Fesarius Therapeutics, a startup founded by Dr. Jason Spector, chief of the division of plastic and reconstructive surgery at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center and a professor of surgery at Weill Cornell Medicine, recently obtained the U.S. Food and Drug Administration (FDA) 510(k) clearance for its DermiSphere Hydrogel Dermal Regeneration Template (DermiSphere hDRT) – an innovative, collagen-based dermal matrices designed for tissue integration and revascularization for improved wound healing and better patient outcomes. This is a major step forward in marketing and distributing their proprietary technology in the U.S.
Enterprise Innovation interviewed Dr. Spector and Mr. Tom Roueche, President and CEO of Fesarius Therapeutics. In this conversation, Dr. Spector elucidates the processes of innovating and transferring an innovation to a startup. Roueche, a seasoned executive with over 30 years of experience in early and growth-stage companies in the medical device and bio-regenerative technology industries, shares his insight into getting funding and government approval as well as the benefits of commercializing an innovation.