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Focused Ultrasound

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Focused Ultrasound

ldquoWithout health there can be no happinessrdquo

Focused Ultrasound Technology

Two Stories

Focused Ultrasound Foundation

Focused Ultrasound

Early stage revolutionary noninvasive therapeutic technology

Alternative or adjunct Surgery Radiation therapy Drug delivery

Transform treatment Benign and malignant tumors Metastatic cancer Parkinsonrsquos disease amp epilepsy Back pain hypertension

Early Stage

MR 30 years ago Unknown Revolutionized diagnoses Affects everyone

Focused Ultrasound today Unknown ldquoMedicinersquos Best Kept Secretrdquo As important to therapy as MR is to diagnoses In 10 years may affect everyone

Infancy Not science fiction Real today

Essential Tremor Treatment

Awake no anesthesiaNo incisions

No burr holesNo electrodesNo infection

No blood clotsNo brain damage

>
>

Uterine Fibroid

Pre-treatment

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 2: Fusf presentation to share 11.20

ldquoWithout health there can be no happinessrdquo

Focused Ultrasound Technology

Two Stories

Focused Ultrasound Foundation

Focused Ultrasound

Early stage revolutionary noninvasive therapeutic technology

Alternative or adjunct Surgery Radiation therapy Drug delivery

Transform treatment Benign and malignant tumors Metastatic cancer Parkinsonrsquos disease amp epilepsy Back pain hypertension

Early Stage

MR 30 years ago Unknown Revolutionized diagnoses Affects everyone

Focused Ultrasound today Unknown ldquoMedicinersquos Best Kept Secretrdquo As important to therapy as MR is to diagnoses In 10 years may affect everyone

Infancy Not science fiction Real today

Essential Tremor Treatment

Awake no anesthesiaNo incisions

No burr holesNo electrodesNo infection

No blood clotsNo brain damage

>
>

Uterine Fibroid

Pre-treatment

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 3: Fusf presentation to share 11.20

Focused Ultrasound Technology

Two Stories

Focused Ultrasound Foundation

Focused Ultrasound

Early stage revolutionary noninvasive therapeutic technology

Alternative or adjunct Surgery Radiation therapy Drug delivery

Transform treatment Benign and malignant tumors Metastatic cancer Parkinsonrsquos disease amp epilepsy Back pain hypertension

Early Stage

MR 30 years ago Unknown Revolutionized diagnoses Affects everyone

Focused Ultrasound today Unknown ldquoMedicinersquos Best Kept Secretrdquo As important to therapy as MR is to diagnoses In 10 years may affect everyone

Infancy Not science fiction Real today

Essential Tremor Treatment

Awake no anesthesiaNo incisions

No burr holesNo electrodesNo infection

No blood clotsNo brain damage

>
>

Uterine Fibroid

Pre-treatment

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 4: Fusf presentation to share 11.20

Focused Ultrasound

Early stage revolutionary noninvasive therapeutic technology

Alternative or adjunct Surgery Radiation therapy Drug delivery

Transform treatment Benign and malignant tumors Metastatic cancer Parkinsonrsquos disease amp epilepsy Back pain hypertension

Early Stage

MR 30 years ago Unknown Revolutionized diagnoses Affects everyone

Focused Ultrasound today Unknown ldquoMedicinersquos Best Kept Secretrdquo As important to therapy as MR is to diagnoses In 10 years may affect everyone

Infancy Not science fiction Real today

Essential Tremor Treatment

Awake no anesthesiaNo incisions

No burr holesNo electrodesNo infection

No blood clotsNo brain damage

>
>

Uterine Fibroid

Pre-treatment

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 5: Fusf presentation to share 11.20

Early Stage

MR 30 years ago Unknown Revolutionized diagnoses Affects everyone

Focused Ultrasound today Unknown ldquoMedicinersquos Best Kept Secretrdquo As important to therapy as MR is to diagnoses In 10 years may affect everyone

Infancy Not science fiction Real today

Essential Tremor Treatment

Awake no anesthesiaNo incisions

No burr holesNo electrodesNo infection

No blood clotsNo brain damage

>
>

Uterine Fibroid

Pre-treatment

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 6: Fusf presentation to share 11.20

Essential Tremor Treatment

Awake no anesthesiaNo incisions

No burr holesNo electrodesNo infection

No blood clotsNo brain damage

>
>

Uterine Fibroid

Pre-treatment

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 7: Fusf presentation to share 11.20

Uterine Fibroid

Pre-treatment

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 8: Fusf presentation to share 11.20

Uterine Fibroid

Focused Ultrasound Noninvasive no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility

Hysterectomy Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 9: Fusf presentation to share 11.20

Uterine Fibroid

Pre-treatment 9 months post-treatment

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 10: Fusf presentation to share 11.20

Breast CancerPre-treatment

Two weeks post treatment

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 11: Fusf presentation to share 11.20

What is Focused Ultrasound

How does it work

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 12: Fusf presentation to share 11.20

Marriage of Two Innovative Technologies

Focused ultrasound Treat tissue deep in body non-invasively

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 13: Fusf presentation to share 11.20

Marriage of Two Innovative Technologies

Magnetic resonance (MR) or ultrasound (US) imaging Identify and target tissue to be treated Guide and control treatment in real time Immediate confirmation of effectiveness

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 14: Fusf presentation to share 11.20

Focused Ultrasound The Principle

Analogous to a magnifying glass focusing rays of the sunhellip

>

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 15: Fusf presentation to share 11.20

Focused Ultrasound The Principle

Multiple intersecting beams of ultrasound Focused with extreme accuracy (1 mm diameter) Target in body

bull Individual beams pass harmlessly through adjacent tissue

bull Profound effect at point of convergence

>

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 16: Fusf presentation to share 11.20

Thermal ablationHistotripsyDeliver drugsDissolve clots sonothrombolysis Radiation sensitizationDrug activity enhancementSonodynamic therapy Coagulate blood vesselsAmplification of cancer biomarkersImmunomodulationNeuromodulationVasodilationVasoconstriction Stem cell delivery

Effects at Focal Point

Variety of effects variety of disorders

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 17: Fusf presentation to share 11.20

Destroy Tissue Thermal Ablation

Heating any tissue to 130degF (56degC) for 1 second Denatures proteins 100 cell death normal and abnormal

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 18: Fusf presentation to share 11.20

Focal Drug Delivery

Deliver drugs in high concentrations Precisely where needed minimizing systemic toxicity

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 19: Fusf presentation to share 11.20

Lipid Microbubbles

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 20: Fusf presentation to share 11.20

Lipid Microbubbles

Chemotherapeutic agents genes growth factors

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 21: Fusf presentation to share 11.20

Microbubbles Injected

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 22: Fusf presentation to share 11.20

Distribution of Microbubbles

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 23: Fusf presentation to share 11.20

Drugs Released at Focal Point

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 24: Fusf presentation to share 11.20

Focused Ultrasound Procedure

Targeting

Planning

Treating

Confirming Uterine Fibroids

Brain Tumors

Essential Tremor

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 25: Fusf presentation to share 11.20

Focused Ultrasound vs Radiation

Single treatment

Immediate and verifiable effect

Greater precision and accuracy

Real time localization

No cumulative dose

No limitations on lesion size

No limitations on number of treatments

No secondary malignancies

100 cell death

Sharp margins

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 26: Fusf presentation to share 11.20

Sharp Margins

Treated

1 mm

Liver Brain

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 27: Fusf presentation to share 11.20

-

Global Development LandscapeConceptual Preclinical Anecdotal Pilot Pivotal

Other Approvals

FDA Reimbursement

Neurological Essential TremorParkinsonrsquos DiseaseNeuropathic PainBrain TumorsOCD EpilepsyStrokeHydrocephalusTrigeminal NeuralgiaAlzheimerrsquos DiseaseCancer PainDepression

MusculoskeletalBack PainOsteoid OsteomaOsteoarthritisSacroilitis

Oncological BoneProstate TumorsThyroidParathyroidBreast CancerPancreasSoft TissueLiverKidneyHead Neck CancerLung BladderColonEsophagus

CardiovascularHypertensionAtherosclerosisAtrial FibrillationSeptal Perforation

Miscellaneous Acute Tubular NecrosisObesityDiabetesGlaucomaBenign Prostatic HypertrophyUreterocele

Womenrsquos Health Uterine FibroidsUterine AdenomyosisBreast Fibroadenomas

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 28: Fusf presentation to share 11.20

Essential Tremor

Parkinsonrsquos Disease

Neuropathic Pain

Uterine Fibroids

Uterine Adenomyosis

Breast Fibroadenomas

Breast Tumors

Prostate Cancer

Global Development Landscape

ReimbursementSparse Uterine Fibroids

Pain from Bone Metastasis

Regulatory FDA

Cancer Pain

Bladder Cancer

Colon Cancer

Esophageal Cancer

Depression

Regulatory Outside US

Clinical Trials Anecdotal Preclinical ConceptualThyroidParathyroid

Breast Tumors

Pancreatic Tumors

Liver Tumors

Parkinsonrsquos Disease

Soft Tissue Tumors

Uterine Adenomyosis

Breast Fibroadenomas

Osteoarthritis

Hypertension

Hydrocephalus

Alzheimerrsquos Disease

Atherosclerosis

Atrial Fibrillation

Septal Perforation

Trigeminal Neuralgia

Acute Tubular Necrosis

Benign Prostatic Hypertrophy

Head amp Neck Cancer

Lung Cancer

Ureterocele

ThyroidParathyroid

Pain from Bone Metastasis

Pancreatic Tumors

Liver Tumors

Soft Tissue Tumors

Osteoid Osteoma

Back Pain

Kidney Tumors

Brain Tumors

OCD

Kidney Tumors

Neuropathic Pain

Essential Tremor

Prostate Cancer

Epilepsy

Stroke

Obesity

Diabetes

Sacroilitis

Glaucoma

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 29: Fusf presentation to share 11.20

Imagine the Future

Advances in technology Imaging Focused ultrasound Focal drug delivery

Undreamed-of applications

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 30: Fusf presentation to share 11.20

Snake Oil Cure-all

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 31: Fusf presentation to share 11.20

Insert MR videos

Magnetic Resonance Imaging

>
>
>

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 32: Fusf presentation to share 11.20

Limitations

Traumatic Injuries

Scoliosis

Leukemia

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 33: Fusf presentation to share 11.20

Potential Impact on Millions of People

Urgent need widespread availability of focused ultrasound Saving time saving lives

Delay results in unnecessary death disability and suffering Countless individuals friends family you

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 34: Fusf presentation to share 11.20

Medical device development and adoption slow

Decades concept to adoption as standard of care

The Problem

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 35: Fusf presentation to share 11.20

Process Complicated and Inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 36: Fusf presentation to share 11.20

PatientsAcademic research sitesPrivate philanthropyDisease specific foundationsNIHVenture capital private equityIndustryFDAInsurersPatient advocacy organizationsMedical societiesTreatment facilitiesPhysicians numerous specialties

Organizations with Different Agendas

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 37: Fusf presentation to share 11.20

Technical and engineering

Awareness and acceptance patients and physicians

Cultural and turf issues

Financial

Regulatory

Reimbursement

Obstacles

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 38: Fusf presentation to share 11.20

Obscure

No roadmap examples or formulas

Obligated to invent

The Solution

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 39: Fusf presentation to share 11.20

The Challenge

There is nothing more difficult to take in hand more perilous to conduct or more uncertain in

its success than to take the lead in the introduction of a new order of things

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 40: Fusf presentation to share 11.20

Itrsquos all about the patients

saving time saving lives

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 41: Fusf presentation to share 11.20

Purpose of the Foundation

Millions of Lives Improved

AdoptionDevelopment

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 42: Fusf presentation to share 11.20

Overview

Founded 2006 Catalyst to accelerate the development and adoption of FUS

Charlottesville based global impact

Tax exempt high performance entrepreneurial Market driven action and results oriented

Essence of activities Foster collaboration Knowledge create aggregate share

Model Venture philanthropy social entrepreneurship Private funding bridges gap between research amp treatment

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 43: Fusf presentation to share 11.20

Unique Hybrid Organization

Device platform technology

Variety of clinical indicators

Fulfill multiple roles

Research amp Education

Foundation

Medical amp Scientific Society

Patient Advocacy

Organization

Patient Support

Organization

Manufacturers Trade

Association

Focused Ultrasound Foundation

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 44: Fusf presentation to share 11.20

Vision

Focused Ultrasound Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 45: Fusf presentation to share 11.20

Mission

Accelerate development of new applications Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care

Accelerate adoption as standard of care

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 46: Fusf presentation to share 11.20

Culture

Patient centric Uncompromisingly passionately obsessively committed to rapidly

improving quality of life

Catalytic small nimble potent

Reputation contagious enthusiasm and energy Instill in others enthusiasm and energy to precipitate change

Entrepreneurial Create reality from imagined future through human action Accomplishments exceed assets available

Pioneering

Pursuit of excellence Hard work risk taking innovation

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 47: Fusf presentation to share 11.20

Strategic Focus

Its all about the patients saving time saving lives Litmus test of actions and expenditures

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 48: Fusf presentation to share 11.20

Medical societies

Disease specific foundations

Venture capital private equity

Positioning Nexus of Organizations

Academic research sitesPatientsPrivate philanthropy

NIH

Industry

FDA

InsurersPatient advocacy organizations

Treatment facilities

Physicians numerous specialties

Academic research sites

Patients

Private philanthropy

Disease specific foundations

NIH

Venture capital private equity

Industry Insurers

Patient advocacy organizations

Medical societies

Treatment facilities

FDA

Physicians numerous specialties

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 49: Fusf presentation to share 11.20

Currency and Incentives

Reputation trusted independent unbiased 3rd party

Contagious passion and enthusiasm

Information

Funding

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 50: Fusf presentation to share 11.20

Activities

Influence direction

Foster collaboration

Change behavior and policy

Create knowledge clinical evidence best practices amp standards

Cultivate the next generation

Convene the community

Collect and disseminate information

Increase awareness communications

Overcome barriers

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 51: Fusf presentation to share 11.20

Influence Direction

Define areas of clinical benefit

Prioritize indications

Market oriented approach Segment to achieve natural advantage Pick battles Rapid success

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 52: Fusf presentation to share 11.20

Foster Collaboration

Rapidly achieve a critical mass of effort and knowledge

Approach Stimulate innovation Leverage intellectual capital Coordinate activities avoid duplication

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 53: Fusf presentation to share 11.20

Change Behavior amp Policy

Amalgamate stakeholders into a cohesive ecosystem Patient centric Sense of urgency

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 54: Fusf presentation to share 11.20

Develop Evidence of Safety Efficacy

Organize conduct and fund research

Niche translational application gt discovery Preclinical clinical technical High risk early stage broad impact

Iconoclastic model Collaboration vs individual glory Patient centric vs investigator centric Commercially successful products vs publications grants promotion

Programs tightly managed milestone driven External award investigator initiated

bull Competitive peer reviewed Internal Foundation initiated

bull Brain liverbull Contracts with academia industry

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 55: Fusf presentation to share 11.20

Establish Best Practices Set Standards

Research training patient care

Centers of Excellence multidisciplinary luminary sites Showcase for technology Venue for collaboration

Partnership of academia industry and the Foundation

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 56: Fusf presentation to share 11.20

Centers of Excellence

UVA Focused Ultrasound Center Partnership

University of Virginia Commonwealth of VA FUS Foundation InSightec and GE

Institute for Cancer Research London Partnership

Royal Marsden Hospital FUS Foundation Philips Medical

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 57: Fusf presentation to share 11.20

Cultivate the Next Generation

Educate clinicians and scientists

Fund fellowships and internships

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 58: Fusf presentation to share 11.20

Convene the Community

Organize and fund meetings symposia workshops Exchange knowledge and ideas Foster collaborations and partnerships

Foundation Organized

Foundation Supported

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 59: Fusf presentation to share 11.20

Collect and Disseminate Knowledge

Website

Newsletter

Journal

Collaborative Network

Social Media

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 60: Fusf presentation to share 11.20

Website ndash fusfoundationorg

Encyclopedia of Focused Ultrasound

Source of information Comprehensive Trusted Up to date

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 61: Fusf presentation to share 11.20

Newsletter

Published monthly

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 62: Fusf presentation to share 11.20

Journal

Online open access peer reviewed Partnership with International Society for Therapeutic Ultrasound

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 63: Fusf presentation to share 11.20

Collaborative Network

Inventory updated quarterly on website Laboratory research sites investigators and projects Clinical research sites Commercial treatment sites Manufacturers

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 64: Fusf presentation to share 11.20

Social Mediafacebookcomfocusedultrasound

FUSFoundation

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 65: Fusf presentation to share 11.20

Increase Awareness Communications

Inform stakeholders heat up environment advance field Awareness events Media relations

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 66: Fusf presentation to share 11.20

Media Relations

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 67: Fusf presentation to share 11.20

Media Relations (cont)

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 68: Fusf presentation to share 11.20

Media Relations (cont)

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 69: Fusf presentation to share 11.20

Overcome Barriers

Regulatory partner with FDA bridge not a barrier Pathway for new indications preclinical amp clinical studies

Reimbursement obtain coverage amp payment Evidence of safety efficacy cost Patient advocacy Physician advocacy

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 70: Fusf presentation to share 11.20

Strategy

Leverage capital Cofunding and funding indirect costs royalties

Best in class management practices

Transparency accountability Continuous quality improvement policies procedures systems

Align vision mission strategy organization culture resources Prime the pump

Engage Foundations Government Industry VCs Assume functions of Foundation

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 71: Fusf presentation to share 11.20

Organization

Flat flexible responsive to market and technology shifts

17 Athletes A-players Unbounded highly intelligent highly educated Healthcare professionals with over 140 years of experience 3 PhDs 3 MBAs 2 MDs Interns

Organized in teams

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 72: Fusf presentation to share 11.20

Portfolio of Programs

Research

Collaborative network

Educational fellowships

Meetings symposia workshops

Centers of Excellence

Regulatory

Reimbursement

Communications

Website

Newsletter

Online open-source journal

Accelerate development and adoption

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 73: Fusf presentation to share 11.20

Board of Directorshellipactive engaged passionate

Neal F Kassell MD Chairman Focused Ultrasound FoundationProfessor Department of Neurosurgery University of Virginia

Lodewijk JR de Vink Founding Partner Blackstone Health Care Partners

Dorothy N BattenFormer Director Landmark Communications

S Morry Blumenfeld PhDFounding Partner Meditech Advisors Management

Eugene V FifeFounding Principal Vawter Capital

John R GrishamAuthor

Daniel P Jordan PhDPresident Emeritus Thomas Jefferson Foundation Inc

Frederic H Moll MDCo-founder Intuitive SurgicalCo-founder and Executive Chairman Hansen Medical

Steve H RusckowskiCEO Quest Diagnostics Former CEO Philips Healthcare

Edward D Miller MDFormer CEO Johns Hopkins Medicine

Andrew C von Eschenbach MDPresident Samaritan Health Initiatives

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 74: Fusf presentation to share 11.20

Academic and Corporate Relationships

S Morry Blumenfeld PhD InSightec Shareholder

Neal F Kassell MD InSightec Shareholder UVA Faculty Member

Andrew C von Eschenbach MD Histosonics Director and Shareholder

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 75: Fusf presentation to share 11.20

CouncilPurpose

Harness goodwill increase awareness

Members Passionate enthusiastic advocates

bull Amanda Megargelbull Michael Milkenbull Paula Newcombbull Wyndham G Robertsonbull Mary Lou Seilheimerbull Alice H Siegel bull Aaron Stern MD PhDbull Howard amp Fredi Stevensonbull Jack Syerbull The Honorable Nicholas F Taubmanbull Kitchie Tollesonbull Linda K Zecher

bull Jane P Batten (Co-chair)bull Charles H Seilheimer Jr (Co-chair)bull John B Adams Jrbull Ellen Blockbull Edgar M Bronfman Srbull Thomas N amp Nancy J Chewning bull Norwood amp Marguerite Davisbull Diane Hellerbull Cecelia S Howellbull Dean L Kamenbull Robert Khayat PhDbull Shirley Lin PhD

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 76: Fusf presentation to share 11.20

Resources ndash Financial Capital

Committed to date $54 million 62 from Individuals 24 from CorporationsOrganizations 10 from Government 3 from Foundations

Next 3 years invest additional $25 million Research Fellowships Centers of Excellence Regulatory amp Reimbursement Symposium Website Newsletter Journal

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 77: Fusf presentation to share 11.20

Fund Raising Model

Patients are impatient

Target venture philanthropists Rapid decisions Results oriented Staying power Substantial capacity (value every dollar every donor)

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 78: Fusf presentation to share 11.20

Value Proposition

Once in a lifetime opportunity Investment with extraordinary return Social not economic

Big idea compelling story noble cause

Perfect timing

Best in class management practices

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 79: Fusf presentation to share 11.20

Results ndash Accelerating Adoption

Magic moment in evolution Opportunity to make a difference

Early stage Small investment = large impact

No major theoretical or technical barriers Development gt Discovery

Brute force application of $ enormous progress

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 80: Fusf presentation to share 11.20

Accelerating Development and Adoption

2020 +$65 million2022 +$50 million2024 +$35 million 2026 +$20 million2028 +$5 million20302013

Millions of Lives Improved

AdoptionDevelopment

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 81: Fusf presentation to share 11.20

Itrsquos all about the patients Saving time Saving lives

Itrsquos all about the patients

Saving time Saving lives

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 82: Fusf presentation to share 11.20

Focused Ultrasound Manufacturers

Acublate SJTU SUNTEC

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 83: Fusf presentation to share 11.20

Research and Commercial Treatment Sites

140+ Research sites

380+ Commercial treatment sites

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 84: Fusf presentation to share 11.20

87

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 85: Fusf presentation to share 11.20

88

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 86: Fusf presentation to share 11.20

89

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 87: Fusf presentation to share 11.20

90

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 88: Fusf presentation to share 11.20

91

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 89: Fusf presentation to share 11.20

92

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 90: Fusf presentation to share 11.20

93

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 91: Fusf presentation to share 11.20

94

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 92: Fusf presentation to share 11.20

Global Development Landscape

Q3 2013

Reimbursement

FDA

Other Approvals

Pivotal

Pilot

Anecdotal

Preclinical

Conceptual

14

2

22

14

4

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 93: Fusf presentation to share 11.20

14

Dissolve Bloodclots Sonothrombolysis

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 94: Fusf presentation to share 11.20

24

Dissolve Bloodclots Sonothrombolysis

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 95: Fusf presentation to share 11.20

34

Dissolve Bloodclots Sonothrombolysis

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 96: Fusf presentation to share 11.20

44

Dissolve Bloodclots Sonothrombolysis

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 97: Fusf presentation to share 11.20

Procedure Targeting

Structures to be avoided

Region to be treated

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 98: Fusf presentation to share 11.20

Procedure Planning

Automatic planning

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 99: Fusf presentation to share 11.20

Procedure Treatment

Temperature measurement

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 100: Fusf presentation to share 11.20

Procedure Guidance

Move to next target

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 101: Fusf presentation to share 11.20

Procedure Confirmation

Pre treatment

Post treatment

Treatment plan

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 102: Fusf presentation to share 11.20

Internship Program

Back to Activities Slide Back to Organization Slide

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 103: Fusf presentation to share 11.20

Procedure Targeting

Structures to be avoided

Region to be treated

14

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 104: Fusf presentation to share 11.20

Procedure Planning

Automatic planning

Manual adjustment

24

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 105: Fusf presentation to share 11.20

Procedure Treatment

Real time guidance

Temperature measurement

Adjust treatment parameters

34

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 106: Fusf presentation to share 11.20

Procedure Confirmation

Confirmation of effectiveness

Retreat if necessary

44

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 107: Fusf presentation to share 11.20

Pre-treatment

15

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 108: Fusf presentation to share 11.20

Targeting

25

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 109: Fusf presentation to share 11.20

Planning

35

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 110: Fusf presentation to share 11.20

Treatment

45

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 111: Fusf presentation to share 11.20

Post-treatment Confirmation

55

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 112: Fusf presentation to share 11.20

Sonication size

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 113: Fusf presentation to share 11.20

116

Unique

Accelerate development of device

Platform technology Multiple mechanisms of action Variety of medical disorders

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 114: Fusf presentation to share 11.20

117

Patient Support Organization

Advocacy Group Grass Roots Increase Awareness

bull Patientsbull Physiciansbull Insurers

Facilitate Reimbursement

Fibroid Relief Prototype

FR Website ndash 71000 visitors since January 2009

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 115: Fusf presentation to share 11.20

118

Team

Jill Roberts

Whitney Robertson Mary Rose Serafini

John Snell PhD

Interns

Mark Adcock

Rachel Browning

Matt Eames PhD

Jessica Foley PhD

Arik Hananel MD MBA BsCs

Melissa Healy

Sara Horton

Heather Huff-Simonin MBA

Robin Jones

Neal Kassell MD

Susan Klees

Pamela Minetti MBA

Dave Moore MSc

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 116: Fusf presentation to share 11.20

Potential Impact Urgent Need

Millions of People

With theFoundation

Without theFoundation

2000 2010 2020 2030

Cumulative adoption

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 117: Fusf presentation to share 11.20

120

Use of Funds

Research $9 million Meetings Symposia Workshops $1 million Fellowships $1 million Centers of Excellence $1 million Reimbursement Initiative $1 million Core Programs $7 million

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 118: Fusf presentation to share 11.20

121

Research

External Awards $2 million

Parkinsonrsquos Disease $24 million

Brain Tumors $850000

Pancreatic Cancer $250000

Liver Cancer $250000

Breast Cancer $600000

Stroke $600000

Epilepsy $500000

Brain Technology $800000

Back Pain $500000

$9 million

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 119: Fusf presentation to share 11.20

12213

Management Practices

Highest standards not-for-profit for profit Best practices policies processes systems Continuous Quality Improvement People

Strategic Plan Reviewed and updated frequently Acting gt studying and planning

Culture Entrepreneurial market driven results oriented Patient centric Itrsquos all about the patients

Operating plan and program management Updated annually quarterly weekly

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 120: Fusf presentation to share 11.20

12323

Management Practices

Governance Articles of incorporation bylaws Board of Directors represent all stakeholders Audit amp compensation committees Legal review

Finance Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 121: Fusf presentation to share 11.20

12433

Management Practices

People Philosophy lsquoArsquo players athletes Quarterly performance review against objectives Biannual external compensation review Structured hiringtermination process Employee handbook

Research awards and contracts Contracting legal and sponsored program expertise Peer reviewed research advisory committee Competitive program funding committee Monitoring milestones progress reports payments

IT Infrastructure Backups security redundancy

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 122: Fusf presentation to share 11.20

125

Use of Funds

Research $96 million Fellowships $14 million Centers of Excellence $41 million Communications $36 million Reimbursement $18 million Miscellaneous $400000 Development $22 million

$23 million

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 123: Fusf presentation to share 11.20

12613

Individual Donors (updated 91912)

Anonymous

Bob and Glorie Bailie

Baker Construction Group

Aimee and Frank Batten Jr Foundation

DN Batten Foundation

Frank and Jane Batten

Mr and Mrs David A Beach

Anson and Debra Beard

The Bernstein Law Firm LLC

Ms Lois Berry

Birdsall Family Fund

Ellen and Ronald Block Family Foundation

Dr and Mrs S Morry Blumenfeld

Rich and Roxanne Booth

Charles R Bronfman

Edgar M Bronfman and Jan Aronson

Peter and Nancy Brooks

Scott Byron and Company Inc

Phebe Cambata

The Caruthers Foundation

Mr and Mrs Norton E Cater

Mr and Mrs John Chamales

Roy R Charles Charitable Trust

Derwood and Johanna Chase

Tom and Nancy Chewning

Christian Broadcasting Network Inc

Moffett and Dupre Cochran

Mr and Mrs Victor M Dandridge Jr

Mr and Mrs Terrence D Daniels

Mr and Mrs John Stewart Darrell

Mrs Margareta CH Douglas

Mrs Francis Dulaney

Joan and Barry Elman

Mr and Mrs Albert D Ernest

Fibroid Foundation

Eugene V Fife Family Foundation

Bruce D Fisher

Margaret and Thomas Flynn

Penny and John Freund

Mr and Mrs Donald Geller

Struthers and Frederick Gignoux

Mark and Judy Giles

Leslie and Richard Gilliam

Mr and Mrs Donald Goldsmith

Ms Audrey Gould

Julann Griffin

Marge and Joe Grills

Mr and Mrs Eugene R Hack Jr

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 124: Fusf presentation to share 11.20

127

Individual Donors (updated 91912)

Jim and Sue Haden

Carolyn Hadesman and Family

John A Hartford Foundation Inc Matching Gift Program

The Hassenfeld Foundation

Diane and David Heller

Herndon Foundation

Mary Buford and Frederick P Hitz

The Joseph M and Lisa B Hogan Charitable Fund

Ulrike Hoffmann-Burchardi and Dirk Willes

Horton Foundation Fund in CACF

The Horwich Family Foundation

Mr and Mrs Robert M Huff

Chad D Inman

Dean Johnson

Mr Thomas NP Johnson III

Lou and Dan Jordan

Drs Neal and Lee Kassell

Marcia and Jonathan Kean

The Keeley Family Foundation

The Kellogg Organization Inc

Mr and Mrs Donald A King Jr

Mr and Mrs Douglas M Kinney

Mr James B Klutznick

Mrs Delores J Kuberka

Mr and Mrs Fritz R Kundrun

Diana Levin

Lawrence and Carol Levy

Dr Stanley H Levy

John L Lewis IV

Mr and Mrs Harvey L Lindsay Jr

Terry J Lockhart

Mr and Mrs John Lucey

St Lukersquos Hospital

John and Dudley MacFarlane

Chrisanne Mannion

Paul and Diane Manning

Jill Kiersky and Andrew Marcus

Mr and Mrs Donald Mazzoni

Janice McArdle Cancer Research Foundation

Patrick McCarthy

Melville Foundation

Methodist Hospital

Milken Family Fund

Mitford Childrenrsquos Foundation

Frederic Moll

Mr and Mrs Victor A Morgenstern

Thos Nelson Jr Initiative of the Community Foundation

Serving Richmond and Central Virginia

Paula and Rob Newcomb

Dick and Judy Nunley23 127

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 125: Fusf presentation to share 11.20

128

Individual Donors (updated 91912)

Joy Marie Polefrone

Prince Charitable Trusts

Dr MG Pat Robertson

The Robertson Foundation

Wyndam Robertson

Mr and Mrs Thomas C Rodeno

Felicia W Rogan

Madison Rogers

Harry and Ady Rosenberg

Mr and Mrs Charles M Rotgin

Steve and Deborah Rusckowski

Mr Raymond L Rusnak

Cari and Michael Sacks

The Adler Schermer Foundation

Valerie Beth Schwartz Foundation

Mr and Mrs Charles H Seilheimer Jr

Linda Rae Sher

Rick and Sherry Sharp The Community Foundation

Serving Richmond and Central Virginia

Dr James A Shield Jr

Alice H Siegel

Mr and Mrs Thomas A Silberman

Jane-Ashley and Peter Skinner

Albert H Small

The Eddie and Jo Allison Smith Family Foundation Inc

Oscar F SmithMarjorie Smith Charles Charitable Fund of

the Community Serving Richmond and Central Virginia

Robert H Smith Family Foundation

Mr and Mrs Francis M Stanis

Barbara and Cyrus Sweet III

Virginia and John Syer

Fay Davis Taylor In Memory of Bertrand L Taylor III

Sandra Thomas

Jane Tolleson

Ms Cecile Trop

Sarah Beck and Wojtek Uzdelewicz

Eleanor Cameron Van Clief Foundation

Mrs Faith Van Clief

Sheri Waddell

Mr and Mrs Herbert S Wander

Mark Warner and Lisa Collis

The Watterson Foundation

R Ted and Sheila Weschler

Custis Westham Fund of the Community Foundation

Serving Richmond and Central Virginia

Jane Woldenberg Family Foundation

Laurie and Bruce Zessar

Michael Zoller Family Philanthropic Fund

33 128

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 126: Fusf presentation to share 11.20

129

Corporate Donors and Sponsors

Abbott Laboratories

Cooley Godward Kronish

Crutchfield Corporation

EDAP

Elbit

Elekta

GE Healthcare

IGT

Imasonic

InSightec

International Society for

Therapeutic Ultrasound (ISTU)

JJA Instruments

JP Morgan

The Kellogg Organization Inc

Meditech Advisors

Methodist Hospital

Microsoft

Ogilvy Public Relations

Philips Healthcare

Siemens

St Lukersquos Hospital

Supersonic Imagine

Theraclion

University of Virginia

Varian Medical Systems Foundation

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 127: Fusf presentation to share 11.20

Process complicated and inefficient

Technology RampD

Pre-clinical proof of concept

Design engineering

manufacturing

Evidence safety efficacy cost

IP generation and protection

Regulatory approval

Marketing sales support

Insurancereimbursement

Physician andScientist education

Patientadvocacy

Physicianadvocacy

Training andcredentialing

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 128: Fusf presentation to share 11.20

Uterine Fibroids Approved FDA 2004 CE 2003

before treatment

planning

post-treatment

>

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 129: Fusf presentation to share 11.20

Pain Palliation of Bone MetastasesPatient with osteolytic breast cancer metastasis at right iliac bone

Pain score of 55 before treatment reduced to 0 at 3M follow up

Note At 3M new bone formation and thickening

of cortical layer in treatment area

CT Before Treatment

>

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 130: Fusf presentation to share 11.20

Prostate Cancer - Transrectal

>

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 131: Fusf presentation to share 11.20

Prostate Cancer - Transurethral

>

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 132: Fusf presentation to share 11.20

Breast CancerPre-treatment

Two weeks post treatment

>

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 133: Fusf presentation to share 11.20

Liver Tumors

post treatment dose maps (in blue)

and post treatment T1W C

>

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 134: Fusf presentation to share 11.20

Facet RhizotomyFocused ultrasound energy treats in the same locations as RF ablation

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 135: Fusf presentation to share 11.20

Neuropathic Pain ndash Zurich Research

>

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 136: Fusf presentation to share 11.20

Brain TumorsAccumulated thermal dose

at end of treatmentDiffusion weighted image

immediately after treatmentT1w contrast enhanced image

immediately after treatment

>

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 137: Fusf presentation to share 11.20

140

Capsulotomy for OCD

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation
Page 138: Fusf presentation to share 11.20

FUSF

Focused Ultrasound Foundation

  • Slide 1
  • ldquoWithout health there can be no happinessrdquo
  • Two Stories
  • Focused Ultrasound
  • Early Stage
  • Essential Tremor Treatment
  • Uterine Fibroid
  • Uterine Fibroid (2)
  • Uterine Fibroid (3)
  • Breast Cancer
  • Slide 11
  • Marriage of Two Innovative Technologies
  • Marriage of Two Innovative Technologies (2)
  • Focused Ultrasound The Principle
  • Focused Ultrasound The Principle (2)
  • Effects at Focal Point
  • Destroy Tissue Thermal Ablation
  • Focal Drug Delivery
  • Lipid Microbubbles
  • Lipid Microbubbles (2)
  • Microbubbles Injected
  • Distribution of Microbubbles
  • Slide 23
  • Focused Ultrasound Procedure
  • Focused Ultrasound vs Radiation
  • Sharp Margins
  • Global Development Landscape
  • Global Development Landscape (2)
  • Imagine the Future
  • Slide 30
  • Snake Oil Cure-all
  • Magnetic Resonance Imaging
  • Limitations
  • Potential Impact on Millions of People
  • The Problem
  • Process Complicated and Inefficient
  • Organizations with Different Agendas
  • Obstacles
  • The Solution
  • The Challenge
  • Slide 41
  • Purpose of the Foundation
  • Overview
  • Unique Hybrid Organization
  • Vision
  • Mission
  • Culture
  • Strategic Focus
  • Slide 49
  • Currency and Incentives
  • Activities
  • Influence Direction
  • Foster Collaboration
  • Change Behavior amp Policy
  • Develop Evidence of Safety Efficacy
  • Establish Best Practices Set Standards
  • Centers of Excellence
  • Cultivate the Next Generation
  • Convene the Community
  • Collect and Disseminate Knowledge
  • Website ndash fusfoundationorg
  • Newsletter
  • Journal
  • Collaborative Network
  • Social Media
  • Increase Awareness Communications
  • Media Relations
  • Media Relations (cont)
  • Media Relations (cont) (2)
  • Overcome Barriers
  • Strategy
  • Organization
  • Portfolio of Programs
  • Board of Directorshellipactive engaged passionate
  • Academic and Corporate Relationships
  • Council
  • Resources ndash Financial Capital
  • Fund Raising Model
  • Value Proposition
  • Results ndash Accelerating Adoption
  • Accelerating Development and Adoption
  • Slide 82
  • Focused Ultrasound Manufacturers
  • Research and Commercial Treatment Sites
  • Slide 86
  • Slide 87
  • Slide 88
  • Slide 89
  • Slide 90
  • Slide 91
  • Slide 92
  • Slide 93
  • Slide 94
  • Global Development Landscape (3)
  • Dissolve Bloodclots Sonothrombolysis
  • Dissolve Bloodclots Sonothrombolysis (2)
  • Dissolve Bloodclots Sonothrombolysis (3)
  • Dissolve Bloodclots Sonothrombolysis (4)
  • Procedure Targeting
  • Procedure Planning
  • Procedure Treatment
  • Procedure Guidance
  • Procedure Confirmation
  • Internship Program
  • Procedure Targeting (2)
  • Procedure Planning (2)
  • Procedure Treatment (2)
  • Procedure Confirmation
  • Pre-treatment
  • Targeting
  • Planning
  • Treatment
  • Post-treatment Confirmation
  • Sonication size
  • Unique
  • Patient Support Organization
  • Team
  • Potential Impact Urgent Need
  • Use of Funds
  • Research
  • Management Practices
  • Management Practices (2)
  • Management Practices
  • Use of Funds (2)
  • Individual Donors (updated 91912)
  • Individual Donors (updated 91912) (2)
  • Individual Donors (updated 91912) (3)
  • Corporate Donors and Sponsors
  • Process complicated and inefficient
  • Uterine Fibroids
  • Slide 132
  • Prostate Cancer - Transrectal
  • Prostate Cancer - Transurethral
  • Breast Cancer (2)
  • Liver Tumors
  • Facet Rhizotomy
  • Neuropathic Pain ndash Zurich Research
  • Brain Tumors
  • Capsulotomy for OCD
  • Focused Ultrasound Foundation