MiMedx wins federal court ruling on Axiofill FDA classification

MiMedx Group, Inc. (Nasdaq: MDXG) announced that the U.S. District Court for the Northern District of Georgia vacated two FDA determinations regarding the regulatory classification of its AXIOFILL product, a human placental-derived extracellular matrix particulate.

The court vacated FDA's finding that AXIOFILL is not a Section 361 HCT/P on the grounds that it is more than minimally manipulated, and also vacated FDA's classification of AXIOFILL as a biological product rather than a medical device. Both matters were remanded to FDA for further consideration consistent with the court's order.

The court found that FDA had incorrectly interpreted its minimal-manipulation regulation by focusing on the placental disc's function in the donor — specifically its role as a selective barrier between fetal and maternal circulatory systems — rather than considering the tissue characteristics relevant to reconstruction, repair, or replacement in the recipient.

On the classification question, the court found FDA's determination that AXIOFILL should be classified as a biological product to be "arbitrary and capricious," noting the agency had classified other commercially available human-derived particulate products as medical devices without providing "a reasonable explanation or record of evidence" for treating AXIOFILL differently.

"This ruling favorably addresses the central issues of this matter," said Joseph H. Capper, Chief Executive Officer of MIMEDX. "We continue to believe that AXIOFILL meets the requirements for classification as a Section 361 HCT/P, and we look forward to engaging constructively with FDA as it reconsiders the matter consistent with the Court's order."

AXIOFILL was launched in 2022. The company is based in Marietta, Georgia.

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