The FDA has granted a groundbreaking approval to Humacyte for its off-the-shelf, bioengineered blood vessel implant, designed to replace a patient’s damaged artery following traumatic injuries to the arms or legs.
The current surgical standard of care involves harvesting one of the patient’s own veins to act as a new carrier of oxygenated blood, or relying on a synthetic graft—but not all patients can undergo those procedures, and they may carry risks of contamination or infection.
Humacyte’s tissue-based Symvess is designed to be universally implantable, to help rapidly reconnect the vascular system when a patient is facing the loss of a limb.
During its clinical development, it has been used to repair injuries resulting from car accidents, gunshots and industrial accidents, according to the company—and it has also been employed in front-line hospitals in Ukraine to treat wartime wounds through a humanitarian aid program.
Humacyte’s founder and CEO, Laura Niklason, said the FDA’s approval marks a milestone not just for the company, but for the field of regenerative medicine overall.
“We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option,” Niklason said in a statement, adding that the field of treating arterial injuries has not seen “substantial innovation in decades.”
Described as a sterile, acellular implant, Symvess is composed of extracellular matrix proteins that help support the structure of human blood vessels. The engineering process uses smooth muscle cells derived from donor aortic tissue and cell banks to grow the matrix within a bioreactor before the cells are washed away from the implant leaving the biocompatible structure behind.
“Currently available treatment options are limited for vascular trauma, which can lead to severe and potentially life-threatening complications,” the FDA’s Nicole Verdun, director of CBER’s Office of Therapeutic Products, said in an agency statement. “Today’s decision to approve a new therapeutic product based on novel medical technology represents important progress in addressing a significant unmet medical need.”
Humacyte is also developing its engineered vessel approach for use in building fistula access grafts for patients who need dialysis, as well as for people facing peripheral or coronary artery disease.