Mayo Clinic study results back bioengineered vessels, Humacyte reports

DURHAM — Humacyte, a biotechnology platform company based in Durham, is reporting positive results from their recent FDA-regulated clinical study conducted at the Mayo Clinic of its bioengineered blood vessels.

The study followed 29 patients with chronic limb-threatening ischemia (CLTI), an outcome of end-stage peripheral artery disease (PAD). The patients were treated with the implantation of a Human Acellular Vessel (HAV), a bioengineered tissue, to facilitate revascularization. In 76% of patients, two 42cm-long HAV segments were required to achieve the bypass lengths needed.

The results were extremely positive, with a 100% technical success rate and no major adverse HAV-related events reported. After a nine-month follow-up, the limb salvage rate for patients was 86%.

Peripheral artery disease affects around 1 in 20 Americans over the age of 50, occurring when blood flow is limited by blocked arteries. The disease can lead to tissue damage, ulcers, and the risk of amputation. Further complicating treatment is the fact that 40% of patients lack a suitable vein for a bypass. These are the challenges Humacyte is seeking to address.

“Millions of individuals suffering from PAD today deserve treatment options that are not only effective, but that reduce unnecessary pain and suffering,” Laura Niklason, M.D., Ph.D., Humacyte’s CEO and founder said in a statement. “The results of this Mayo Clinic clinical study demonstrate the potential of the HAV to bridge existing gaps in treatment and provide an alternative that is ready off-the-shelf for surgeons to use to help prevent the loss of limb and life.”

Triangle’s Humacyte sending its own type of help to Ukraine: Engineered blood vessels

The HAV product can also be used in traumatic injury. Humacyte received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for use in vascular trauma in May of this year. The company also has a Phase 2/3 trial underway aiming to support an application for a Biologics License Application (BLA) to the FDA later this year. In the meantime, the company is involved in a humanitarian program in Ukraine, providing the HAV to hospitals on the frontlines of the war since June 2022.

Results from the most recent Mayo Clinic study were presented this past weekend at the Midwestern Vascular Conference in Minneapolis, MN.