SUPPORT FOR UKRAINE
Providing 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 Human Acellular Vessel™ (HAV™) for use in in cases of war trauma in their hospitals. Having learned of the HAV and its success in our clinical trials and expanded access case patients, the surgeons thought it would be beneficial for use in patients they were faced with treating.
The team at Humacyte quickly worked on navigating the waters of multinational health regulatory organizations, including the Office of Internal Programs within the U.S. FDA as well as the Ukraine Ministry of Health, to arrange approval for the investigational HAV to be sent overseas into an active warzone for humanitarian use. While shipping details were being arranged, our clinical and medical departments worked tirelessly to remotely train Ukrainian surgical teams to work with the HAV, with thorough instructions around handling, suturing, and post-operative care. As the surgeons would later learn, the human-like qualities of the bioengineered vessel were so exact that there was little to no learning curve compared to working with native vessel.
After multiple attempts to arrange the challenging transportation of the vessels overseas, the Humacyte team was finally able to schedule the shipment, and the cargo container arrived safely in Kyiv, Ukraine just a month and a half after the original request for the HAVs was received.
By the end of June two HAVs had already been implanted in injured civilians, and in the months since delivery our Human Acellular Vessels have been used to treat over a dozen soldiers and civilians injured because of the war in Ukraine. Post-operative surgical implant data and thorough follow-up data has been reported by the surgical teams at their respective clinical sites for each patient treated. The clinical results have been outstanding and immensely informative as Humacyte moves towards filing our Biologics License Agreement, or BLA, for our leading indication in vascular trauma. The Ukrainian patient implant and follow-up outcomes will accompany the extensive data collected from our ongoing V005 clinical trial being conducted in the U.S. and Israel as we move towards commercialization of the product in the vascular trauma space.
As a company, Humacyte is exceptionally proud to have contributed to the ongoing medical relief efforts in Ukraine over the last year. Supporting the patients and brave medical providers has been an honor for us as they face the daily struggles of this humanitarian crisis. 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 have aided in training the Ukrainian teams to work with the HAV.