Humacyte’s HAV Performance in Ukraine War Injuries Evaluated

August 15, 2023—Humacyte, Inc. announced the presentation of the clinical results of a year-long humanitarian program in Ukraine in which the company’s investigational human acellular vessel (HAV) was provided to five hospitals on the frontlines to treat traumatic vascular injuries.

War injuries in Ukraine have led to tens of thousands of amputations, many of which occur because blood flow cannot be restored after the injury, advised the company.

The humanitarian program was initiated in May 2022 when the company provided investigational HAVs to hospitals in Vinnytsia, Dnipro, Odessa, Kyiv, and Kharkov in response to Ukrainian surgeon requests. Humacyte worked with the International Office of the FDA and the Ukrainian Ministry of Health to obtain approval for the program. Humacyte then trained Ukrainian surgeons by video conference on how to implant the HAV.

The findings were presented at the 2023 Military Health System Research Symposium, held August 14-17 in Kissimmee, Florida.

According to the company, the HAV has been used in Ukraine to treat 19 patients (as of July 2023) with a range of traumatic vascular injuries, including gunshots, shrapnel, blasts, and industrial accidents.

Clinicians reported that the rate of success in treating patients with the HAV was high, with an observed 30-day HAV patency of 95%. At 30 days after treatment with the HAV, the limb salvage rate was 100%. In addition, there was 100% patient survival and no cases of infection of the HAV. There was one patient whose HAV had to be removed due to shrapnel-related bleeding.

“The most expensive thing in life, in love, in war, and in limb-saving vascular reconstruction is time,” commented Oleksandr Sokolov, MD, in the company’s press release, Dr. Sokolov, a Ukrainian vascular surgeon and HAV implanter in the humanitarian program, continued, “The novel bioengineered, off-the-shelf HAV provides time to the surgeon and patient. It has the potential to be a significant advancement in treating life-threatening combat vascular injuries.”

HAV, a regenerative medicine product candidate, is designed to provide surgeons with a universally implantable, bioengineered human vessel. It is intended to be available to the surgeon immediately and provide a potentially life- and limb- saving option in circumstances where synthetics are not indicated and autologous vein is not feasible.

Humacyte stated that clinical results suggest that the HAV is durable and highly infection-resistant, and therefore may be well suited for treating the contaminated wounds created by major wartime blast and shrapnel injuries.

The new data will be included as part of the data in the Humacyte’s Biologics License Application (BLA) to the FDA, which is planned for fourth quarter 2023.

The planned BLA will build on results from Humacyte’s pivotal trial studying the HAV in treating patients with vascular injury in the extremities. The company recently announced that enrollment was completed in the trial.

The HAV also received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation in May 2023 for urgent arterial repair following extremity vascular trauma. The RMAT designation allows for close collaboration between Humacyte and the FDA during the application process.

The HAV is comprised of the same tissue that makes up natural human vessels, thereby having the potential to repopulate with the patient’s own cells. The HAV is designed to be off-the-shelf and can be produced at commercial scale in Humacyte’s existing manufacturing facilities, providing thousands of vessels for treating injured patients, stated the company.