A potential medical breakthrough more than two decades in the making will have to wait a little longer before becoming widely available.
Humacyte, which has developed lab-grown blood vessels to treat people with traumatic injuries and other conditions, was expecting the FDA to approve its product by Aug. 10. But on Friday, a day before the deadline, the company said the agency has asked for more time to finish its review.
The company said the FDA noted that Humacyte’s vessels are “a first-in-class product” and that the treatment’s priority review status only left the agency with six months to assess its safety and efficacy, compared to the standard 10 months. Regulators haven’t said how much longer the review will take, according to Humacyte.
Laura NiklasonHumacyte needs the approval. The company told investors in May that it only had $115.5 million in cash and cash equivalents on hand, enough to fund it for “at least 12 months.” In an interview with Endpoints News last month, CEO Laura Niklason said the company’s runway is a bit longer, and that a loan could fund the company “well into 2026.”
The Durham, NC-based biotech company is a pioneer in the regenerative medicine field. The company was co-founded by Niklason, a bioengineer and anesthesiologist, in 2004. It was a time when extraordinary experiments in petri dishes and lab animals suggested that scientists may soon be able to grow new tissues or even whole organs in the lab. Yet most of those grand ambitions have yet to materialize.
Even Humacyte’s seemingly simpler goal of developing blood vessels has taken longer than expected. Its vessels are grown on biodegradable polymer tubes for about two months before being stripped of all cells, leaving behind a white casing of collagen and other structural proteins that is implanted in patients to minimize potential immune reactions.
“We’ve treated nearly 600 patients, and we’ve never had an episode of clinical rejection,” Niklason said. “We’ve been in man for almost 12 years, and we’ve never been put on clinical hold, ever.”
The FDA submission was largely based on a Phase 2/3 study of 51 people with limb injuries. Humacyte’s acellularized vessels restored blood flow in about 90% of patients, while the other 10% ended up requiring amputations. Although there was no placebo control in the study, Humacyte believes its approach is superior to synthetic vessels made from plastic, where 24% of patients typically end up with amputations.
“We compared our outcomes to published outcomes from synthetic grafts. And that was agreed with the FDA,” Niklason said.