Humacyte announces results from FDA sponosored study on HAV

Humacyte announced the presentation of results from a Food and Drug Administration, FDA,-regulated, investigator-sponsored clinical study conducted at the Mayo Clinic. In the study the investigational HAV is being evaluated in patients with chronic limb-threatening ischemia, CLTI, the end stage of peripheral artery disease, PAD. The presentation at the Midwestern Vascular Conference in Minneapolis, MN, entitled Outcomes of Arterial Bypass Using the Human Acellular Vessel In Patients With Chronic Limb Threatening Ischemia, concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. This is an important result since approximately 40% of patients requiring lower extremity bypass do not have saphenous vein available, which is the standard of care for treating this challenging disease state. The presentation reported the outcomes of 29 patients, with a mean age of 71 and having no available vein to use as a bypass graft, who underwent HAV implantation. Of these 29 patients, 97% had previously experienced unsuccessful revascularization procedures on the extremity and 21 had tissue loss or gangrene. Based on the state of this disease, this patient group had a 30-50% one-year risk of amputation. Notably, surgery in 22 patients necessitated a tibial artery target, a surgical procedure involving the fusion of two 42 cm long HAVs to achieve the required bypass length. Surgeons reported that the operations to implant the HAV achieved a 100% technical success rate, without any HAV-related major adverse events reported. At a median follow-up of nine months, the secondary patency rate for patients implanted with the HAV was 72%. The limb salvage rate was 86%, corresponding to only a 14% amputation rate.