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

项目摘要： 我们的长期目标是使透明质酸增强的聚合物经导管主动脉瓣（HAPTAV）商业化 具有手术植入机械瓣膜的耐久性，不需要终身抗凝，避免 基于组织的TAV出现的问题，并且由低成本的合成材料制成，使用自动化的 制造业一种新型生物材料，由工程塑料（聚乙烯）制成，在分子水平上， 与天然存在的生物分子（透明质酸或HA）互锁， 血液友好型聚合物小叶，具有工程合成聚合物的耐用性。在实验室和 这些瓣膜显示出优异的血流动力学性能和耐久性，无任何血栓 形成或钙化。通过第一阶段的应用，我们的目标是证明长期耐用性， 血液动力学和HAPTAV的性能达到或超过国际标准，并采取了初步的 逐步制定商业化战略，为SBIR第二阶段和A系列做好准备 经费我们将在目标1和目标2中使用我们目前的第一阶段设计原型HAPTAV。目标1将具有 独立实体根据国际标准（ISO）测试长期疲劳和血流动力学性能 标准Aim 2将与标准行业合同研究组织（NAMSA）合作， 提交前和监管策略，并促成与FDA的会议。我们将与Larta Inc.到 制定我们的商业化战略，以进行第二阶段申报。YoungHeartValve，LLC于2009年共同创立， 2020年初由心脏瓣膜工程和心血管专家Dasi博士（首席技术官） James博士（首席运营官），他是一位知名的聚合物材料科学家， HA-聚乙烯材料的发明者。托德·托姆巴先生于2020年年中加入YoungHeartValve，担任首席执行官， 总统他带来了超过三十年的医疗器械行业，特别是心脏瓣膜置换 商业化的经验，团队。

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.