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Jason Schulte

Biocompatibility and Tissue Regeneration Laboratory

Agneta Simionescu, Ph.D., Dan Simionescu, Ph.D.

Christopher Wright, M.D.

Tissue-Engineered

Regeneration of Myocardium:

Making New Heart Muscle

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Heart attack damages tissue and is replaced with scar tissue presence of

scar tissue causes changes that lead to congestive heart failure (CHF)mustreplace scar to prevent or possibly reverse CHF

Current gold standard is heart transplantation, but severe shortage of donor

organs

Prevalence of CHF is 6 million, with about 100,000 new patients likely to

develop CHF each year1

$44 billion spent on CHF in 2015, expected to grow to $97 billion by 2030

Clinical Need

NORMAL INFLAMMATORY CARDIOMYOPATH

Y

1 Lloyd-Jones, D., et al.,Heart Disease and Stroke Statistics--2009 Update: A Report From

the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.

Circulation, 2009. 119(3): p. e21-181.

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Overall Goal:

Develop athick,biomimetic, functional, vascularized

graft for replacement or regeneration of scarred heart

tissue

Develop scaffold by removing cells from animal

tissue

Harvest patients own stem cells and seed on

scaffold Use bioreactor to grow seeded scaffold into

functional tissue-engineered graft

Engineered Heart Tissue Graft for

Replacement of Scar Tissue

CELL

S

BIOREACTO

R

SCAFFOLD

PATIENT

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Cells

Chemicals

Engineered Heart Tissue Graft for

Replacement of Scar Tissue

So far, we have developed and characterized the scaffold

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Developing bioreactor, and planning animal studies

Engineered Heart Tissue Graft for

Replacement of Scar Tissue

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Comparison to Current

ProductsFeature Heart Transplantation Tissue-Engineered Graft

Accessibility

Only 2,200 transplants

performed annually, many more

in need1, 2

Available materials, patients own

cells; accessible to all patients

Immunosuppressive

TherapyCan result in complications Patient-tailored

Cost $997,000 per transplant3 Should be less or comparable

Risk High Significant, but possibly lower

1 Heart Transplants: Statistics. The American Heart Association. Retrieved 24 February

2011. www.americanheart.org2 Organ Procurement and Transplantation Network. U.S. Department of Health & Human

Services. Retrieved 24 February 2011. http://optn.transplant.hrsa.gov/data3 Hauboldt RH, Hanson SG. 2008 U.S. organ and tissue transplant cost estimates and

discussion. Milliman Market Research. April 2008

http://optn.transplant.hrsa.gov/datahttp://optn.transplant.hrsa.gov/datahttp://optn.transplant.hrsa.gov/datahttp://optn.transplant.hrsa.gov/data

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IP: Provisional application filed March 23, 2012; not converted to non-

provisional by CU tech transfer, assignee rights passed to inventors

Regulatory Pathway: High risk, clinical trials necessary

Funding: NIH grants through pre-clinical studies, Angel and VC forsubsequent phases

License or start-up are both possible, dependent upon preclinical data

Commercialization Plan

Phase Time Cost

Additional Lab Development 1 year $30,000

Pre-clinical studies 2 years $250,000

Clinical Trials 5-10 years $10-$40 M

Total 8-13 years $10-$50 M

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Clemson University Biomedical

Engineering Innovation Campus

MissionStrives to develop high-impact medical technology and devices

for disease management and the transfer of

this technology from the bench to bedside.

www.cucubeinc.com