MiMedx Wins Court Ruling Vacating FDA's AXIOFILL Minimal Manipulation and Biologic Classification

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MIMEDX Announces Favorable Federal Court Ruling in AXIOFILL® Regulatory Classification Matter Court Vacates FDA Determinations That AXIOFILL Is Not Minimally Manipulated and Should Be Classified as a Biological Product Order Further Holds That Minimal-Manipulation Analysis Must Consider Tissue Characteristics Relevant to Reconstruction, Repair or Replacement in the Recipient MARIETTA, Ga., Sept. 23, 2026 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced that the U.S. District Court for the Northern District of Georgia issued a favorable ruling in the Company’s litigation challenging the U.S. Food and Drug Administration’s (“FDA”) regulatory classification of AXIOFILL, the Company’s human placental-derived extracellular matrix particulate product. The Court vacated FDA’s determination that AXIOFILL is not a Section 361 HCT/P because it is more than minimally manipulated and FDA’s determination that AXIOFILL should be classified as a biological product rather than a medical device. The Court remanded both matters to FDA for further consideration consistent with its order. “This ruling favorably addresses the central issues of this matter. We are pleased the Court found that the FDA erred in its interpretation of the minimal-manipulation regulation and that the agency did not adequately explain the reasoning behind its divergent classification of AXIOFILL compared with similar products available on the market,” stated Joseph H. Ca

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