TISSIUM, a privately held medtech company that develops biomorphic programmable tissue regeneration polymers, today reported that it received US Food and Drug Administration (FDA) for its vascular sealant application for its Investigational Device Exemption (IDE).
The vascular sealant of is designed to resolve the problem of rapidly achieving hemostasis and preventing postoperative bleeding following peripheral vascular surgery, while at the same time providing biocompatibility and an easy preparation and application procedure for surgeons. In this application, the configuration of TISSIUM’s polymer complements sutures as a sealant for a fully effective surgical closure.
“We are pleased to receive this approval from the FDA as it represents a key milestone that accelerates the development of our vascular indication and triggers the further expansion of our broad platform.We will continue to execute on our strategy to build devices using our core polymer technology and offer applications across multiple therapeutic areas, such as peripheral nerve and hernia repair where we have recently started development.” said Christophe Bancel, CEO of TISSIUM.
Initially developed at the Massachusetts Institute of Technology (MIT) & Brigham and Women's Hospital, Harvard Medical School, the TISSIUM platform leverages proprietary technology which serves as the foundation of a family of fully synthetic, biomorphic and programmable polymers. These polymers are intended to be used as sealants, adhesives, barriers, plugs or as a drug delivery vehicle within the body, as well as as implantable devices produced using 3D printing technology outside the body.