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Humacyte announces publication in Lancet Regional Health - Europe presenting use of Human Acellular Vessel™ (HAV™) to treat vascular injuries in Ukraine
May 9, 2023
- First regenerative medicine technology used in battlefield trauma
- Ukrainian surgeons trained on HAV procedures over video conferencing
DURHAM, N.C., May 09, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the publication in The Lancet Regional Health - Europe detailing the encouraging experience of Humacyte’s investigational Human Acellular Vessel (HAV) in treating battlefield and other vascular trauma injuries suffered in Ukraine-Russia conflict.
The letter, titled ‘Use of Bioengineered Human Acellular Vessels to Treat Traumatic Injuries in the Ukraine-Russia Conflict’ reports how Ukrainian surgeons have been using Humacyte’s investigational HAV to save life and limb, and provides data on the clinical outcomes of patients treated with the conduit.
Humacyte’s initial shipment of HAVs arrived in Ukraine in May 2022, in response to requests from surgeons on the frontlines in that country. Humacyte worked closely with the International Office of the US Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to obtain approval for a humanitarian program, under which Humacyte provided the HAV to hospitals in Ukraine. Additionally, Ukrainian surgeons were virtually trained by video conference to learn the procedures for HAV implantation into patients. Today, the HAV has been used in four hospitals throughout Ukraine.
Since June 2022, 18 patients (13 at time of publication submission) in Ukraine have been treated with the HAV to repair vascular trauma and thereby prevent amputation. Three patients received the HAV to treat arterial wounds after failure of their initial vascular repairs using vein or synthetic grafts. Most patients had sustained major vascular injuries to their limbs from blasts and shrapnel on the battlefield. As of April 2023, all HAVs remained patent with no incidents of infection of the conduits, or amputation of the affected limbs. Follow-up procedures post-surgery found no occurrence of mechanical failure in any of the HAVs implanted.
“The HAV’s real-world trauma experience in the conflict in Ukraine demonstrates its potential to revolutionize regenerative medicine, and to save life and limb worldwide,” said Laura Niklason, CEO at Humacyte. “Humacyte puts patients first and we’re proud to be able to help save lives and prevent additional suffering on the frontlines of battle in Ukraine. We are thrilled to see the potential of the HAV recognized in The Lancet Regional Health - Europe, a journal respected for pioneering medical research globally.”
Humacyte’s HAV is designed to be a universally implantable vascular conduit for use in vascular repair. Importantly, the HAV has shown a low rate of infection in clinical trials, making it well-suited for use in settings such as vascular trauma where wounds may be contaminated with foreign material. The HAV is designed to be available off-the-shelf and ready whenever surgeons need it, potentially saving valuable time and potentially improving patient outcomes in cases requiring urgent vascular repair, for both civilians and military personnel.
The publication of this letter comes as Humacyte nears the completion of enrollment in its Phase 2/3 V005 clinical trial of the HAV in the repair of civilian vascular trauma, a study that is being conducted at Level 1 Trauma Centers in the U.S. and Israel. The HAV has accumulated over 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous access for hemodialysis, and peripheral artery disease. Humacyte plans to file a BLA with the FDA later in 2023.
The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.