Humacyte, Inc. presented at MHSRS the clinical results of a year-long humanitarian program in Ukraine. The Company's investigational Human Acellular Vessel (HAV) was provided to five hospitals on the frontlines to treat traumatic vascular injuries beginning in June 2022. Humacyte's humanitarian program was initiated in May 2022, when the company provided investigational HAVs to hospitals in Vinnytsia, Dnipro, Odessa, Kyiv, and Kharkiv, in response to Ukrainian surgeon requests.

Humacyte worked closely with the International Office of the U.S. Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to obtain approval for the program. Humacyte then subsequently trained Ukrainian surgeons by video conference on how to implant the HAV. Additionally, 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.

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 war blast and shrapnel injuries. Importantly, the HAV can be produced at commercial scale in Humacyte's existing manufacturing facilities, providing thousands of vessels for treating injured patients. The new data demonstrating the HAV's success on the frontlines in Ukraine 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, which recently completed enrollment. 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 has accumulated over 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 peripheral arterial disease. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.