Humacyte today announced that the first Ukrainian patients have received implants of the Human Acellular Vessel (HAV) for the treatment of vascular trauma injuries. The implants are part of Humacyte’s humanitarian relief initiative to provide investigational HAVs to multiple front-line Ukrainian hospitals for the treatment of patients with traumatic injuries.
Humacyte’s HAVs are engineered replacement vessels designed to be durable, infection-resistant and off-the-shelf to address long-standing limitations in vessel tissue repair and replacement. The first two Ukrainian patients—one injured by shrapnel and the other by a gunshot wound—received HAVs earlier this month and are being followed through their recovery. The Ukrainian patient who suffered a severe gunshot wound to the leg had already suffered a failed repair of his artery with a synthetic graft which became infected, and was at risk of limb loss. The HAV implantation restored blood flow to the injured leg, a company press release reports.
“We are inspired by the dedicated and skilled physicians, nurses and medical staff who were trained on use of the HAV and are endeavoring to bring the innovative technology to Ukrainian patients in need,” said Laura Niklason, chief executive officer of Humacyte. “The HAV has demonstrated durability and infection resistance in multiple clinical trials across various vascular applications, and its off-the-shelf availability means it can be quickly employed in emergency vascular repair. We are honored to be able to contribute to the ongoing Ukraine medical relief work to help save the limbs and lives of patients during this conflict.”
The HAV is being evaluated in a Phase 2/3 clinical trial in vascular trauma, when saphenous veins are not a good option or not available, and has received priority designation for the treatment of vascular trauma by the US Secretary of Defense. As the humanitarian effort in Ukraine progresses and patients are treated with the HAV, a press release details that Humacyte continues to work alongside the Office of International Programs within the US Food and Drug Administration (FDA) and the Ukrainian Ministry of Health.
The HAV is an investigational product and has not been approved for sale by the US FDA, the Ukrainian Ministry of Health, or any international regulatory agency, the company advises.