Humacyte (NASDAQ:HUMA) completed enrollment of its Phase 2/3 vascular trauma trial that is expected to support a BLA filing for Humacyte’s human acellular vessel (HAV) in vascular trauma repair planned for the fourth quarter of 2023.
The HAV, a regenerative medicine product candidate, is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries.
The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level 1 trauma centers in the U.S. and Israel.
“We believe that the HAV could revolutionize the ability of surgeons to save the lives and limbs of patients suffering vascular injuries, not only in civilian settings, but also in more challenging environments like the battlefield,” Dr. Laura Niklason, CEO of Humacyte, said in a statement.
“Our regenerative medicine technologies create dramatic new therapies – with the potential to provide treatment options for patients facing loss of life or limb for whom current therapies are either inadequate or not available,” she added.
In addition to the V005 trial, the HAV is also being used in Ukraine under a humanitarian aid program that has treated 19 vascular trauma patients in the ongoing war, demonstrating a high rate of favorable outcomes in treating some of the most difficult and infection-prone vascular injuries. The data from the Ukraine humanitarian program will be included in the BLA filing with the FDA.
