Posted by Michael Wonder on 12 Dec 2023
Humacyte submits biologics license application to US FDA seeking approval of human acellular vessel for the treatment of vascular trauma
12 December 2023 - BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the human acellular vessel under a humanitarian aid program to treat wartime trauma injuries in Ukraine.
Humacyte today announced that it has submitted a biologics license application to US FDA seeking approval of the human acellular vessel in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.
