Humacyte announces U.S. FDA accepted, granted priority review to BLA of HAV

Humacyte announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review to Humacyte’s Biologics License Application, BLA, seeking approval of the Human Acellular Vessel, HAV, in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. “We are very pleased that the FDA has accepted our BLA and has recognized the potential importance of the HAV technology by granting us Priority Review,” said Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte. “The BLA acceptance brings us a major step closer to our goal of providing an innovative regenerative medicine product for patients suffering traumatic vascular injury. Many patients with severe injuries are underserved by the current standard of care, and we are proud of the results that have been seen in our clinical trials and real-world humanitarian efforts.”