Tissium today said it received FDA investigational device exemption for its vascular sealant.
The vascular sealant is designed to quickly achieve hemostasis and prevent post-operative bleeding after peripheral vascular surgeries. It also offers biocompatibility with a simple preparation and application process for surgeons. Tissium’s vascular sealant 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,” CEO Christophe Bancel said in a news release. “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.”
Tissium’s platform uses technology that was originally developed at the Massachusetts Institute of Technology and Brigham and Women’s Hospital, Harvard Medical School, to serve as a foundation of fully synthetic, biomorphic and programmable polymers. The polymers were designed to be used inside the body as sealants, adhesives, barriers, plugs or other drug delivery vehicles, as well as implantable devices.
The IDE approval allows Tissium to continue to expand the platform in its effort to develop a unique platform of polymers, activation technologies and delivery devices for multiple therapeutic areas.