Posted by Michael Wonder on 13 Mar 2018
AmnioFix injectable granted regenerative medicine advanced therapy designation by the FDA for the treatment of osteoarthritis of the knee
9 March 2018 - MiMedx Group today announced that the U.S. FDA has granted MiMedx's micronized amniotic tissue, AmnioFix Injectable, the regenerative medicine advanced therapy designation for use in the treatment of osteoarthritis of the knee.
In its letter to the Company, the FDA confirmed its determination that MiMedx Allogeneic Micronized Dehydrated Human Amnion/Chorion Membrane (micronized dHACM) for the treatment of osteoarthritis (OA) of the knee meets the criteria for RMAT designation. The FDA further stated that MiMedx has provided clinical information to demonstrate preliminary clinical evidence to indicate that the drug has the potential to address unmet medical needs for this condition.
In granting the RMAT designation to MiMedx AmnioFix Injectable for use in the treatment of OA of the knee, the FDA committed to a multidisciplinary comprehensive discussion with MiMedx regarding the Company's development program, including planned clinical trials and plans for expediting the manufacturing development strategy.
