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# Regenerative Medicine Designation for MiMedx Osteoarthritis Therapy
- URL: https://www.fdaweb.com/regenerative-medicine-designation-for-mimedx-osteoarthritis-therapy/
- Published: 2018-03-09T12:00:00.000Z
- Updated: 2026-09-14T23:28:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140951

FDA has granted MiMedx Group a regenerative medicine advanced therapy designation for micronized amniotic tissue, AmnioFix Injectable, and its use in treating osteoarthritis of the knee. In granting the designation, FDA acknowledged preliminary clinical evidence that the drug has the potential to address unmet medical needs for the condition, according to the company. The agency also committed to a multidisciplinary comprehensive discussion with MiMedx regarding the development program, including planned clinical trials and plans for expediting the manufacturing development strategy, it says.