Pulmonary valved conduit xenograft with regeneration potential

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 andamp; 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.TGen Tech, LLC has received NIH STTR Phase I grant to commercialize pulmonary valve conduit for the pediatric population. We have patented decellularized bovine jugular vein valved conduits that have the potential for host cell repopulation and growth with the patient. With this proposal, a team of TGen Tech would enroll in the NIH I-Corps program to help us understand the strategies and steps needed to take this device to the clinical setting and help thousands of pediatric patients.