Humacyte CEO rebuts NYT article questioning FDA approval of Symvess

Humacyte, Inc.

FDA took 19 extra weeks after PDUFA date, consulted three outside surgeons before approving Symvess on Dec 19, 2024.
Dr. Lee, cited as source, resigned from FDA months before approval; his LinkedIn says he 'retired' after a decade.
CEO disputes claim synthetic grafts never rupture; cites MAUDE database showing >25% failures from rupture/death.
In Ukrainian wartime study, all Symvess-treated limbs retained at 30 days with zero infections.
Post-approval study planned to confirm safety; prior studies on 600+ patients never halted for safety.

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