SBIR Phase I:Feasibility of a minimally-invasive biomaterial therapy for heart failure

This Small Business Innovation Research (SBIR) Phase I project will test the feasibility of delivering a biomaterial treatment for myocardial infarction (MI) and heart failure via catheter, thereby paving the way towards translation and commercialization. Despite recent advances in tissue engineering, heart failure post-MI continues to be the leading cause of death in the U.S. with end-stage heart failure patients still relying on donor hearts. Herein, the feasibility of delivering a regenerative matrix via catheter to the heart will be tested. The key objectives of this project are: 1) Demonstrate injection of the myocardial matrix through a catheter in a porcine MI model, and 2) Demonstrate gelation and targeted delivery of the myocardial matrix in a porcine MI model. The broader/commercial impacts of this research are the development of a new minimally invasive therapy for treating the millions of patients that suffer a MI each year, and the drastic reduction in the cost of healthcare related to MI by preventing subsequent heart failure, which is currently estimated at $37.2 billion for indirect and direct costs in 2009. This product will have significant advantages over competing technologies including: 1) minimally invasive delivery, 2) no need for donor organ or cell collection, 3) no need for immunosuppressive therapies, 4) off-the-shelf available treatment, and 5) low cost. Moreover, this will be the first injectable regenerative biomaterial product for treating the millions of patients suffering from MI and heart failure.