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Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma
– Presentations included results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime
About this update from Humacyte, Inc.
[{"type":"text","content":"– Presentations included results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime injuries in Ukraine – – Results showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks – – BLA for an indication in vascular trauma planned to be filed with the FDA during the current quarter – DURHAM, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today 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 wartime 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 V005 trial met its objectives, and the HAV demonstrated a higher 30-day secondary patency rate of 90.2% for the extremity patients compared to 78.9% historically reported for synthetic grafts. Primary patency for the HAV was 81.2% for the extremity patients, although no comparison to synthetic graft primary patency was possible since this measure was...