MIMEDX Announces Favorable Federal Court Ruling in AXIOFILL® Regulatory Classification Matter
Globe Newswire•23/09/2026•16:01 ET
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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
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