Humacyte, Inc. 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. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision regarding the BLA, is August 10, 2024. This targeted PDUFA date is based on the Priority Review grant, which is a mechanismreserved by FDA for products that, if approved, would significantly improve the treatment, diagnosis, or prevention of serious conditions.

Priority Review applications have a six-month review time instead of ten months for a standard review. The Priority Review aligns with the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2023 for urgent arterial repair following extremities vascular trauma. The Priority Review is also consistent with the priority designation given by the Secretary of Defense under Public Law 115-92, which was enacted to expedite the FDA's review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel.

The BLA submission is supported by positive results from the V005 Phase 2 3 clinical trial, as well as real-world evidence from the treatment of traumatic injuries in Ukraine under a Humanitarian Aid Program supported by the FDA. The HAV has accumulated more than 1,200 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.