SBIR Phase I: Novel Hyaluronan Enhanced Polymeric Trans-Catheter Aortic Valve

Project Summary: Our long-term goal is to commercialize hyaluronan enhanced polymeric transcatheter aortic valves (HAPTAVs) that have the durability of surgically implanted mechanical valves, do not require life-long anticoagulation, avoid the emerging problems for tissue-based TAVs, and are made from low-cost, synthetic materials using automated manufacturing. A novel biomaterial, made of engineering plastic (polyethylene) that, at a molecular level, is interlocked with a naturally occurring biomolecule (hyaluronan or HA) is used to make highly hydrophilic, blood-friendly polymer leaflets with the durability of engineered synthetic polymers. In both the laboratory and in live sheep, these valves have shown excellent hemodynamic performance and durability without any thrombus formation or calcification. With this Phase I application we aim to demonstrate that the long-term durability, hemodynamics, and performance of the HAPTAVs meet or exceed international standards, and take the initial steps toward developing a commercialization strategy to position the business for Phase II SBIR and Series A funding. We will use our current Phase I Design prototype HAPTAVs in both Aims 1 and 2. Aim 1 will have independent entities test the long-term fatigue and hemodynamic performance according to international (ISO) standards. Aim 2 will work with a standard industry contract research organization (NAMSA) to prepare an FDA pre-submission and regulatory strategy, and facilitate a meeting with the FDA. We will work with Larta Inc. to develop our commercialization strategy for a Phase II submission. YoungHeartValve, LLC was co-founded in early 2020 by Dr. Dasi (Chief Technology Officer), an expert in heart valve engineering and cardiovascular biomechanics, and Dr. James (Chief Operating Officer), who is an established polymer materials scientist, and the inventor of HA-polyethylene materials. Mr. Todd Tomba, joined YoungHeartValve mid 2020 as CEO and President. He brings over three decades of medical device industry, and specifically heart valve replacement commercialization experience, to the team.Project Narrative: The objective of this project is to develop an advanced polymeric aortic valve that can be implanted using a catheter, avoiding the risks associated with open heart surgery and cardiopulmonary bypass. The plastic leaflets are precisely shaped for excellent blood flow, and engineered to maximize blood compatibility using a natural biomolecule, hyaluronan, which is present in all body tissues. Proving the long-term durability and performance of these novel heart valve implants exceed commercial gold standards will speed translation of the technology to the clinic, and lead to a dramatic improvement in heart valve technology.