Humacyte, Inc. announced the presentation of positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel (HAV) in the treatment of vascular trauma, as well as results from the treatment of war injuries in Ukraine. The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City. Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.

Humacyte plans to file a Biologics License Application (BLA) for the HAV for an indication in vascular trauma patients with the U.S. Food and Drug Administration (FDA) during the current quarter. The V005 trial was a single-arm study conducted in the United States and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events for whom the standard of care, saphenous vein, was not feasible or available to use as a bypass graft. As a single-arm study, the comparators for the HAV results were a systematic literature review and meta-analysis of studies conducted with synthetics grafts, providing a benchmark for comparison.

A total of 69 patients were enrolled in the V005 trial, of which 51 had vascular injury of the extremities and comprised the primary evaluation group for the study. The FDA has advised Humacyte to include in the BLA submission patient outcomes from a humanitarian program conducted in Ukraine. Results for the 16 extremity patients from Ukraine who provided consent for use of their results in the BLA filing were also presented at the meeting, a set of data known as the "V017 trial." Results from V005, the Ukraine humanitarian program, and statistical comparison to historic benchmarks were presented at a symposium titled "Vascular Trauma Repair Clinical Study Results with Humacyte Human Acellular Vessel (V005 & V017 Data)" by Dr. Moore, Dr. Fox, and Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte.

The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, AV 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.