MiMedx wins federal court ruling on Axiofill FDA classification

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Go back to MiMedx wins federal court ruling on Axiofill FDA classification

MIMEDX Announces Favorable Federal Court Ruling in AXIOFILL® Regulatory Classification Matter

September 23, 2026 4:01 PM EDT

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 Companys litigation challenging the U.S. Food and Drug Administrations (FDA) regulatory classification of AXIOFILL, the Companys... More