SBIR Phase II: A Perfusable, Revascularized, Cardiac-Derived Patch for the Treatment of Heart Disease

This Small Business Innovations Research Phase (SBIR) II project is to support the continued development of using proprietary perfusion decellularization technology to create a fully revascularized cardiac patch for the treatment of ischemic heart disease and congenital heart repair. Current surgical approaches for cardiac reconstruction utilize synthetic materials that do not have the ability to grow and remodel with the patient. Feasibility will be demonstrated by in-vitro and in-vivo characterization to create a perfusable cardiac-derived revascularized cardiac patch to promote faster reconstruction of functional tissue by providing a fully perfusable scaffold with a composition and architecture similar to native cardiac tissue. This product will have significant advantages over existing technologies, including: 1) full thickness, biological, cardiac-derived matrix material; 2) vascular supply to support migrating cells and remodeling; 3) superior mechanical properties; and, 4) no need for immunosuppressive therapies. Moreover, this will be the first cardiac-derived, revascularized patch available for treating ischemic areas of the heart. The broader impact/commercial potential of this project, if successful, is the development of a revascularized cardiac patch to treat ischemic heart failure and congenital repair in a way that is superior to existing technologies. While medical advancements have decreased the overall mortality rate for acute myocardial infarction patients, therapeutic options are lacking to address the underlying loss of myocardial tissue, resulting in a mortality rate greater than 33% at five years. Inhibiting the onset or delaying the severity of heart failure will have a significant effect on lowering this mortality rate and reducing the treatment cost of heart failure, which currently is estimated at over $37 billion annually. The use of this product will further enhance the medical and scientific understanding of the mechanisms by which damaged cardiac tissue may be restored/repaired and patient life may be extended following myocardial infarction.