Project Summary: YoungHeartValve (YHV), Inc. is commercializing the Rejuvenate™ Heart Valve, a balloon-expandable, stented, transcatheter aortic heart valve (TAVR) with hyaluronan-impregnated polymeric, flexible leaflets that will obviate the need for chronic anti-coagulation and prevent calcification while simultaneously rivaling the longevity of surgically placed mechanical valves. Unique and novel Dynamic Sealing Technology (DST) that activates once implanted will form fit the valve to provide for a more complete and reliable annular seal, rivaling that of sutured-in-place surgical valves. Further, YHV’s “no tissue / no farm” manufacturing automation and supply chain will significantly reduce the cost and complexity of today’s pericardial based TAVR systems, thereby opening up possibilities for this life-saving technology to truly be adopted worldwide. Aim 1 will verify Valve 2.0 design meets all ISO Standards and begin manufacturing for scale up. Aim 2 will complete acute and chronic animal testing to achieve design freeze (Valve 3.0). This SBIR Phase II grant will help YHV emerge from the “Valley of Death” commonly faced by start-ups. The Rejuvenate™ Valve will be ready for GLP pre-clinical testing and “first-in-human” testing. YHV will have the supply-chain, manufacturing, and distribution relationships required for commercialization, will have raised “Series A” funding in parallel with Phase II funding and have a full-time employee team. YoungHeartValve, Inc. was co-founded by Drs. Dasi (Chief Technology Officer) and James (Chief Operating Officer), based on technology they jointly developed over the preceding decade with NIH funding. Mr. Todd Tomba, YoungHeartValve CEO and President, brings over three decades of medical device industry, specifically heart valve replacement commercialization experience, to the team. Ms. Arthi Rathi, YoungHeartValve CFO, a CPA by professional background, brings over a decade of healthcare financial leadership experience to YHV. Our scientific advisory board consists of key opinion leaders and pioneers in the field of heart valves: Dr. Vinod Thourani (Piedmont Hospital, President of Heart Valve Society), Howard Hermann (Professor of Cardiovascular Medicine, U. Penn) and Dr. Janarthanan Sathananthan (Director of the Centre for Heart Valve Innovation Bench Testing Laboratory, U. British Columbia). YoungHeartValve is currently being incubated within GeorgiaTech’s VentureLab with lab space in the GATV innovation labs.