Humacyte, Inc. (HUMA), a clinical-stage biotechnology company focused on universally implantable, bioengineered human tissue at commercial scale, announced Tuesday positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel or HAV in vascular trauma repair.
In pre-market activity on Nasdaq, Humacyte is trading at $3.83, up 3.51 percent.
The single-arm clinical trial showed that the HAV in the study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.
Humacyte said it plans to file a Biologics License Application or BLA for the treatment of vascular trauma with the Food and Drug Administration during the fourth quarter of 2023.
The V005 trial was conducted in the United States and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. 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 company said the V005 trial was a success, and the principal comparison of 30-day secondary patency for the HAV in the clinical trial was 90.2 percent for the extremity patients, compared to 81.1 percent historically reported for synthetic grafts.
Humacyte is currently preparing a BLA for use of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and saphenous vein is not feasible to the FDA before the end of the year.
The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
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