Pulmonary valved conduit xenograft with regeneration potential

2019年7月启动的同品种器械STTR第1阶段授权（#1R41HL147771-01）的目的是 确认概念证明，并进行初步可行性研究，以将专利技术商业化 (US专利#9，795，573和9，283，241），下文称为TxGuardTM，用于肺瓣膜管道 患有先天性心脏病（CHD）的儿童需要CHD影响约40，000名新生儿 每年在美国。根据CDC的研究，估计有超过250万人 生活在美国的CHD患者。新的TxGuardTM设备有可能克服临床 缺陷（钙化、血栓形成、耐久性、硬度、感染敏感性等）与 商业产品。该技术的新奇在于物理交联的脱细胞化的 在植入开始时提供足够的机械性能， 随着宿主细胞在组织中重新繁殖， TGen Tech已经为NIH项目的I-Corps组建了一个团队，该团队展示了必要的相关信息。 将技术商业化的经验。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.