From MassDevice in March 2018:
MIMedx won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week.
The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee.
Can we stop with the talk that AmnioFix is not FDA approved?!?