Humacyte gets FDA approval for bioengineered blood vessel
Durham-based Humacyte, founded by three female scientists in 2004, has received marketing approval from the U.S. Food and Drug Administration for its first product – a groundbreaking bioengineered blood vessel designed to be universally implantable.
The vessel, trademarked as SYMVESS, was approved for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is no
t feasible. The technology is technically called an acellular tissue engineered vessel (ATEV). It can be transported and stored in sterile packages, without complicated freezing or other handling procedures. After it’s implanted, it’s eventually overgrown by the body’s healing mechanism, ultimately dissolving, being resorbed and eliminated by the recipient.
In 2006 the North Carolina Biotechnology Center provided Humacyte a $150,000 Small Business Research Loan. The company subsequently raised nearly $480 million, including a $150 million equity investment from Fresenius Medical Care, the world's leading provider of products and services for patients with renal diseases and for surgical care centers. Humacyte became a publicly traded company in August 2021.
Humacyte received a special priority designation from the U.S. Secretary of Defense in 2022 to use the SYMVESS vessel to treat vascular trauma in members of the military. That same year Humacyte worked with the FDA’s Office of International Programs as well as the Ukraine Ministry of Health to provide SYMVESS vessels to Ukraine for humanitarian use treating wounded civilians and soldiers with vascular injuries suffered in the Russian invasion.
“We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. SYMVESS has been made possible by our innovative bioengineering science along with the contributions of many patients, healthcare providers and Humacyte team members,” said Laura Niklason, M.D., Ph.D., co-founder and chief executive officer, in a news release issued after the FDA decision was handed down.
“SYMVESS’s approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte. The FDA’s full approval of SYMVESS is a transformational event for the company and our bioengineering technology platform. Even more importantly, we believe SYMVESS provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades. We look forward with great excitement to our upcoming commercial launch of SYMVESS, and we have recruited and trained a terrific team to execute on our sales and marketing missions.”
Humacyte has numerous products in the pipeline, including a vessel for arteriovenous access in patients with kidney failure who need hemodialysis. That was the first product to receive Regenerative Medicine Advanced Therapy designation from the FDA and has also received FDA Fast Track designation. Humacyte is also developing multiple novel cell and tissue applications such as in coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes, and even as a “host” for islet cells to regenerate the pancreas when implanted.
“It’s great to see these success stories from North Carolina-based startups that received early funding from NCBiotech,” said Mike Carnes, vice president of emerging company development at NCBiotech. “We’re delighted that Humacyte has achieved FDA approval of its SYMVESS product. Kudos to this innovative company for advancing a disruptive technology to market, providing a new solution for vascular injuries.”