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

项目总结： 我们的长期目标是将透明质酸增强型聚合物经导管主动脉瓣(HAPTAVs)商业化 具有手术植入的机械瓣膜的耐用性，不需要终身抗凝，避免 基于组织的TAV正在出现的问题，这些TAV是由低成本的合成材料使用自动化 制造业。一种新型的生物材料，由工程塑料(聚乙烯)制成，在分子水平上， 与自然产生的生物分子(透明质酸或HA)互锁被用来制造高度亲水性， 血液友好型聚合物小叶，具有工程合成聚合物的耐用性。在实验室和在 活体绵羊，这些瓣膜表现出优异的血流动力学性能和耐用性，没有任何血栓。 形成或钙化。通过这个第一阶段的应用，我们的目标是证明长期耐用性， 血液动力学，HAPTAVs的性能达到或超过国际标准，并采取初步 制定商业化战略的步骤，以定位第二阶段SBIR和系列A的业务 资金问题。我们将在AIMS 1和AIMS 2中使用我们当前的第一阶段设计原型HAPTAV。AIM 1将拥有 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，准备FDA 提交前和监管战略，并促进与FDA的会议。我们将与Larta Inc.合作 为第二阶段提交制定我们的商业化战略。杨心瓣有限责任公司成立于 2020年初由心脏瓣膜工程和心血管专家达西博士(首席技术官)主持 生物力学和詹姆斯博士(首席运营官)，他是一位知名的聚合物材料科学家，以及 HA-聚乙烯材料的发明者。托德·通巴先生于2020年中加入Young HeartValve，担任首席执行官和 总统。他带来了三十多年的医疗器械行业，特别是心脏瓣膜置换 商业化的经验，给了团队。

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.