Pulmonary valved conduit xenograft with regeneration potential

具有再生潜力的肺动脉瓣导管异种移植物

• 批准号: 10086830
• 负责人: Naren R Vyavahare
• 金额: $ 5.5万
• 依托单位: ANNOVIANT, INC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-02 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10086830
• 关键词: Affect; Cattle; Cells; Centers for Disease Control and Prevention (U.S.); Child; Childhood; Clinical; Devices; Enrollment; Exhibits; Feasibility Studies; Grant; Growth; Implant; Infection; Innovation Corps; Learning; Legal patent; Natural regeneration; Newborn Infant; Patients; Phase; Population; Predisposition; Pulmonary valve structure; Risk; Small Business Technology Transfer Research; Structure of jugular vein; Technology; Tissues; United States; United States National Institutes of Health; Xenograft procedure; calcification; commercialization; congenital heart disorder; crosslink; experience; mechanical properties; pediatric patients; programs; thrombogenesis

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.

我们于 2019 年 7 月启动的谓词 STTR 第 1 阶段拨款 (#1R41HL147771-01) 的目标是 确认概念验证并进行初步可行性研究以将专利技术商业化 （美国专利# 9,795,573 和 9,283,241），以下简称 TxGuardTM，用于肺动脉瓣导管 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 居住在美国的冠心病患者。新的 TxGuardTM 设备有潜力克服临床难题 缺陷（钙化、血栓形成、耐久性、僵硬、感染易感性等） 商业产品。该技术的新颖之处在于物理交联的脱细胞 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的可降解性。 TGen Tech 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知识 将该技术商业化的经验。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。