Humacyte, Inc. 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 (HAV) 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.

The limb salvage rate was 86%, corresponding to only a 14% amputation rate. PAD is increasingly prevalent, affecting approximately one in every 20 Americans over the age of 50.CLTI is an advanced, severe form of PAD that poses a significant risk to limb health and viability. Importantly, the HAV can be produced at commercial scale in Humacyte's existing manufacturing facilities, providing thousands of vessels for treating patients in need.

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, arteriovenous access for hemodialysis, and PAD. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.