Humacyte today announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.
A press release details that the BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.
“Submitting the BLA to the FDA is a pivotal milestone in achieving our goal of providing regenerative human tissues to injured patients, at commercial scale,” said Laura Niklason, chief executive officer of Humacyte. “I want to thank the patients and medical professionals who participated in our clinical studies, and our Humacyte team for their tremendous effort and dedication in completing the BLA submission for this first-in-class product candidate.”
The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing. Humacyte has requested priority review of the application and, if granted, the review should be completed within six months of the filing acceptance date. In May 2023, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma. In addition, the HAV was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel, such as traumatic injuries.
Humacyte details that the HAV, a bioengineered tissue, is under investigation as an infection-resistant, universally implantable conduit for use in vascular repair. “Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to improve outcomes and reduce complications for patients. The HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, which are expected to have the capacity to provide thousands of vessels for treating patients in need,” a press release reads.
Humacyte claims that the HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for haemodialysis, and peripheral arterial disease.
The company advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
