MiMedx Says it Received Favorable Court Ruling in Axiofill Classification Matter

04:53 PM EDT, 09/23/2026 (MT Newswires) -- MiMedx (MDXG) said late Wednesday that the US District Court for the Northern District of Georgia vacated the Food and Drug Administration's determinations that its Axiofill matrix particulate product is not minimally manipulated and should be classified as a biological product. The court concluded that the FDA's classification of Axiofill as a biological product was "arbitrary and capricious" because it had not provided a record of evidence supporting its decision, according to a statement. The court has remanded matters to FDA for further consideration consistent with the order, the company said, adding that it looks forward to engaging constructively with FDA. The FDA did not immediately respond to a request for comment from MT Newswires.