MiMedx Gets Favorable Court Ruling in FDA Treatment-Classification Dispute
By Katherine Hamilton
MiMedx said it received a favorable ruling in its litigation challenging the Food and Drug Administration's classification of its wound treatment Axiofill.
A Georgia district court ruled against the FDA's decision that Axiofill should be classified as a biological product rather than a medical device. It called the FDA's designation of Axiofill as a biological product "arbitrary and capricious," stating that there wasn't enough explanation for the decision.
The court also vacated the FDA's decision that Axiofill isn't a Section 361 human cell, tissue and cellular and tissue-based product (HCT/P) because it is more than minimally manipulated, MiMedx said.
The court remanded both matters to the FDA for further consideration consistent with its order.
MiMedx is seeking classification of Axiofill as a Section 361 HCT/P. The product, which launched in 2022, is a human placental-derived extracellular matrix particulate product.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
September 23, 2026 16:46 ET (20:46 GMT)
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