The FDA approved Humacyte’s lab-grown blood vessel Symvess despite internal warnings from agency scientists about its safety and efficacy, The New York Times reported March 24.
The decision, made in December without a public review, has sparked criticism from medical experts and former FDA officials.
Humacyte designed its study to assess blood flow through its bioengineered vessel 30 days after implantation, the report said. However, FDA records showed that among 54 study participants, four people died, four underwent amputations and several cases lacked proper follow-up data.
Despite the concerns, Humacyte launched marketing efforts targeting hospitals and the military, with intentions to sell the vessels to treat injuries sustained in combat, according to the Times. The company also reported a 84% success rate in medical journals and investor meetings. while the FDA found the success rate to be only 67%.
The product is accompanied by a black box warning, the agency’s most severe, saying potential failures that “can result in life-threatening hemorrhage.” The FDA also requires ongoing safety monitoring, though critics have argued the vessel should not have been approved given the uncertainty of its performance.
