Pulmonary valved conduit xenograft with regeneration potential

我们于2019年7月启动的谓词STTR第一阶段拨款(#1R41HL147771-01)的目标是 确认概念论证并进行专利技术商业化的初步可行性研究 (美国专利#9,795,573&9,283,241)，此后称为TxGuardTM，用于肺瓣膜管道 先天性心脏病(CHD)儿童所需的。大约4万名新生儿患有先天性心脏病 每年在美国。根据疾控中心的研究，估计有超过250万人 生活在美国的冠心病患者。新的TxGuardTM设备具有克服临床 缺陷(钙化、血栓形成、耐久性、僵硬、感染敏感性等)与 商业产品。这项技术的新奇之处在于物理上交联的脱细胞 在植入开始时提供足够机械性能的组织，并且缓慢 当宿主细胞重新填充组织时，可降解性。 TGen Tech已经为NIH的i-Corps项目组建了一个团队，展示了必要的相关 将这项技术商业化的经验。该团队渴望通过I-Corp计划了解 商业化所需的具体步骤，特别是我们项目的知识产权和监管风险，以及 验证客户需求。

The objective of our predicate STTR Phase 1 grant (#1R41HL147771-01) activated in July 2019 is to confirm proof of concept and conduct initial feasibility studies to commercialize patented technologies (US Patents # 9,795,573 & 9,283,241), hereafter referred a TxGuardTM, for pulmonary valved conduits needed for children with congenital heart disease (CHD). CHD affects approximately 40,000 newborns each year in the United States. According to CDC studies, there are estimated more than 2.5 million patients with CHD living the US. The new TxGuardTM device has a potential to overcome the clinical deficiencies (calcification, thrombogenicity, durability, stiffness, susceptibility to infection, etc.) with the commercial products. The novelty of the technology lies in the physically crosslinked decellularized tissue that provides adequate mechanical property at the beginning of the implant and slow degradability as the host cells repopulate the tissue. TGen Tech has assembled a team for the I-Corps at NIH program that exhibits necessary relevant experience to commercialize the technology. The team is eager to learn through I-Corp program about the specific steps required for commercialization, specifically IP and regulatory risk for our project, and validate the customer needs.