RMAT Designation granted by FDA to AmnioFix Injectable for treatment of Osteoarthritis

MiMedx Group which is a leading developer and marketer of regenerative and therapeutic biologics asserted that the U.S Food and Drug Administration has extended 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 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.

Parker H. “Pete” Petit, Chairman and Chief Executive Officer said “The FDA’s RMAT designation for AmnioFix Injectable is an important milestone for MiMedx and highlights the importance of introducing promising therapies in areas of considerable unmet medical need. We are especially pleased that the FDA will meet to discuss expediting our development and manufacturing of this product to serve the needs of patients suffering from OA of the knee. We look forward to discussions with the FDA.

An investigational regenerative medicine therapy is eligible for RMAT designation if its intended to treat, modify , reverse or cure a serious condition , and if preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition.