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

SBIR 第一期：新型透明质酸增强型聚合物经导管主动脉瓣

• 批准号: 10325141
• 负责人: Todd Charles Tomba
• 金额: $ 44.24万
• 依托单位: YOUNGHEARTVALVE LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325141
• 关键词: Accreditation; Address; Adolescent; Animal Sources; Anticoagulant therapy; Anticoagulation; Biocompatible Materials; Biomechanics; Blood; Blood Platelets; Blood flow; Businesses; Cardiac Surgery procedures; Cardiopulmonary Bypass; Cardiovascular system; Catheters; Chronic; Clinic; Collaborations; Colorado; Contracts; Deposition; Engineering; FDA approved; Fatigue; Finite Element Analysis; Funding; Future; Goals; Gold; Hand; Heart Valve Prosthesis; Heart Valves; Hospitals; Hyaluronan; Image; Implant; In Vitro; Incubated; Industry; Industry Standard; International; Intervention; Laboratories; Lead; Letters; Licensing; Life; Mainstreaming; Mechanics; Medical Device; Molecular; National Heart, Lung, and Blood Institute; National Institute of Biomedical Imaging and Bioengineering; Ohio; Operative Surgical Procedures; Outcome; Patients; Performance; Phase; Pilot Projects; Polyethylenes; Polymers; Positioning Attribute; Property; Proteins; Research Contracts; Resistance; Risk; Scientist; Series; Shapes; Sheep; Sinus; Small Business Innovation Research Grant; Societies; Speed; Technology; Testing; Thrombosis; Thrombus; Tissues; Translating; Translations; United States National Institutes of Health; Universities; Velocimetries; Work; aortic valve; aortic valve replacement; base; calcification; commercialization; cost; density; design; experience; heart valve replacement; hemocompatibility; hemodynamics; hydrophilicity; in vivo; innovation; innovative technologies; meetings; new technology; novel; particle; phase 1 designs; prototype; stability testing; success

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.

项目摘要： 我们的长期目标是商业化透明质酸增强的聚合物经导管主动脉瓣（HAPTAVS） 具有外科手术植入机械瓣的耐用性，不需要终身抗凝性，避免 基于组织的TAV的新兴问题，由自动化的低成本合成材料制成 制造业。一种由工程塑料（聚乙烯）制成的新型生物材料，在分子水平上是 与天然存在的生物分子（透明质酸或HA）互锁的用来使高度亲水性， 具有工程合成聚合物的耐用性的血液友好聚合物小叶。在实验室和 活绵羊，这些阀门表现出出色的血液动力学性能和耐用性，没有任何血栓 形成或钙化。在此阶段I应用中，我们旨在证明长期耐用性， 血液动力学和HAPTAVS的表现达到或超过国际标准，并以最初的态度 制定商业化策略的步骤，以定位第二阶段SBIR和A系列 资金。我们将在AIM 1和2中使用当前的I阶段设计原型Haptavs。AIM 1将具有 独立实体根据国际（ISO）测试长期疲劳和血液动力学性能 标准。 AIM 2将与标准行业合同研究组织（NAMSA）合作，准备FDA 预提交和监管策略，并促进与FDA的会议。我们将与Larta Inc.合作 制定我们的第二阶段提交的商业化策略。 Youngheartvalve，LLC共同创立了 2020年初Dasi博士（首席技术官），心脏瓣膜工程专家和心血管专家 生物力学和詹姆斯博士（首席运营官）是一位既定的聚合物材料科学家， HA-聚甲基材料的发明者。托德·托姆巴（Todd Tomba）先生，于2020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设备行业，尤其​​是心脏瓣膜更换 商业化经验，给团队。