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.
The focus of this National Science Foundation (NSF) Small Business Innovation Research (SBIR) Project was the development of a new, minimally-invasive biomaterial therapy for the treatment of myocardial infarction (MI) and heart failure. As a result of this research, Ventrix has successfully demonstrated the development of a tissue engineering product for MI and heart failure, which has the potential to positively affect more than 500,000 people per year. Specifically, Ventrix has illustrated the feasibility of VentriGel, its biocompatibility with the native myocardium, its compatibility with currently available catheter delivery methods, demonstrated its safety in preclinical models and established a trend towards efficacy. We believe that we can mitigate the deleterious effects of MI and heart failure through the use of VentriGel and it’s adoption as a clinical therapy. Based on our Phase I findings, we conclude that delivery of VentriGel through a minimally invasive, clinically relevant, percutaneous transendocardial approach is both feasible and safe. We have devised a sterilization technique that maintains the bioactivity of the product as well as demonstrated its bioretention at the site of injection(s) and lack of biodistribution to other parts of the body. We have successfully completed the first steps towards developing a low-priced attractive therapy capable of significantly reducing the heart failure death rate following MI.
