Humacyte, Inc. announced the launch of an initiative to provide Human Acellular Vessels (HAVs) to multiple hospitals in Ukraine for the treatment of wounded civilians and soldiers with vascular injury, with the first shipment of HAVs departing the U.S. today. HAVs are engineered, off-the-shelf replacement vessels being developed for vascular repair, reconstruction and replacement. Humacyte worked with the Office of International Programs within the U.S. Food and Drug Administration (FDA) as well as the Ukraine Ministry of Health to coordinate export and import of the investigational HAV for humanitarian use.

Six hospitals in Ukraine, including in Kyiv, Kharkiv and other cities, will be the recipients of the initial shipment. Additional site requests are currently being processed. The HAV is being evaluated in a Phase 2/3 clinical trial in vascular trauma for use a vascular replacement to restore blood flow to a limb, when saphenous veins or synthetic grafts are not a good option.

The HAV has received priority designation the treatment of vascular trauma by the U.S. Secretary of Defense. The HAV is an investigational product and has not been approved for sale by the FDA or any international regulatory agency.