Provided Humanitarian Aid for Vascular Trauma Injuries
in Ukraine Hospitals
Shortly after the Russian invasion of Ukraine in March of 2022, Humacyte received a letter from Ukrainian surgeons asking for access to our investigational Human Acellular Vessel™ (HAV™) for use in cases of war trauma in their hospitals. Having learned of the HAV and its use in our clinical trials and expanded access case patients, the surgeons thought it would be beneficial for use in their patients.
The team at Humacyte worked with multinational health regulatory organizations, including the Office of Internal Programs within the U.S. FDA, as well as the Ukraine Ministry of Health, to seek approval for the HAV to be sent overseas into an active warzone for humanitarian use. While shipping details were being arranged, our clinical and medical departments trained the Ukrainian surgical teams remotely on how to use the HAV, with thorough instructions around handling, suturing, and post-operative care. As the surgeons would later learn, the bioengineered vessel required little to no learning curve compared to working with a native vessel.
After working with the multiple international agencies, the Humacyte team was able to successfully ship the HAVs into Kyiv, Ukraine, just a month and a half after the request for the HAVs was received.
By the end of June, two HAVs were implanted in injured civilians, and in the months since delivery, our HAVs treated over a dozen soldiers and civilians injured because of the war. Post-operative surgical implant data and thorough follow-up data were reported by the surgical teams at their respective clinical sites for each patient treated. The Ukrainian patient implant and follow-up outcomes will accompany the extensive data collected from our completed V005 clinical trial conducted in the U.S. and Israel.
As a company, Humacyte is exceptionally proud to have contributed to the medical relief efforts in Ukraine. We are grateful to our entire team here in Durham, NC, for their incredible work to see this effort through, and express our gratitude to the surgical teams in the U.S. and Poland who trained the Ukrainian teams.