Clinical Update Presented on Humacyte’s Investigational Human Acellular Vessel for Treatment of Vascular Trauma

September 9, 2022—Humacyte, Inc. announced the presentation of a clinical update on the company’s human acellular vessel (HAV) for treatment of vascular trauma. Humacyte, a clinical-stage biotechnology platform company, is developing universally implantable bioengineered human tissues, complex tissue systems, and organs at commercial scale.

The update was presented by Todd E. Rasmussen, MD, (Colonel [Retired], United States Air Force), at the 44th International Committee of Military Medicine World Congress held in Brussels, Belgium, on September 5-9, 2022.

According to the company, Dr. Rasmussen reported to an audience of NATO and other international surgeons that the incidence of wartime vascular injury has increased over the past several decades. He added that vascular injury, whether in a military or civilian setting, is a leading cause of death and or amputation. The presentation highlighted the clinical progress of the HAV, including updates on his own experiences and those of his colleagues using the vessel to treat patients, as well as the potential of the investigational product to overcome limitations in care.

Dr. Rasmussen concluded that injured service members and those with certain complex injuries in the civilian sector could benefit from the use of a readily available and infection-resistant vascular conduit that would facilitate quick implantation and restoration of blood flow, even in the setting of contaminated wounds, such as those encountered on the battlefield.

“The incidence of vascular trauma in the modern combat setting has increased fivefold over the past century,” stated Dr. Rasmussen in Humacyte’s press release. “Advances in prehospital casualty care now allow surgeons to attempt repair and limb salvage in two-thirds of these cases. Because most injuries are the result of blast injuries and are associated with soft tissue wounds and contamination, there is a pressing need for a readily available, infection-resistant biologic conduit for arterial repair or bypass.”

Dr. Rasmussen continued, “Currently available synthetic conduits such as plastic and polyester grafts, and even cryopreserved allografts, are not practical or durable in these settings. The HAV has the physical and biologic properties to be an ideal solution for wartime vascular injury and even many injuries sustained in the civilian setting.”

Humacyte advised that its investigational HAVs were recently provided to several front-line Ukrainian hospitals as part of a humanitarian relief effort, allowing doctors to use the HAVs to treat patients with traumatic vascular injuries during the conflict. Patients successfully treated to date under the humanitarian program include those with a range of traumatic injuries, including those from gunshots, shrapnel, and industrial accidents.

Humacyte is working with the Office of International Programs within the FDA and the Ukrainian Ministry of Health as the humanitarian efforts in Ukraine progress, and the company continues to provide this additional treatment option to those affected.

The HAV is an investigational product and has not been approved by the FDA, the Ukrainian Ministry of Health, or any international regulatory agency, stated the company.

Humacyte stated that the HAV is designed to offer off-the-shelf availability and resistance to infection, as well as to address long-standing limitations in vascular tissue repair and replacement. Humacyte’s HAVs are currently being evaluated in multiple advanced-stage clinical trials in vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The HAV has been implanted in > 500 patients under eight clinical trials and combined with the FDA’s Expanded Access Program.

On February 28, 2022, the company announced that 5-year data from a phase 2 clinical trial of patients receiving the HAV for arteriovenous access in hemodialysis were published by Professor Tomasz Jakimowicz, MD, et al in the European Journal of Vascular and Endovascular Surgery companion journal EJVES Vascular Forum (2022;54:58-63).

On January 31, Humacyte announced results from the first series of compassionate-use cases of the HAV for the treatment of critical limb ischemia and vascular trauma. Alexander Kersey, MD, presented the findings at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society, held January 27-30 in Snowmass, Colorado. The presentation, “Real World Experience with the Human Acellular Vessel: A Bioengineered Implant for Arterial Repair That Expands Limb Salvage Options,” is available on the company’s website at Humacyte.com.