MiMedx Says FDA Still Won't Budge on Axiofill Designation, Files Lawsuit

By Dean Seal

MiMedx Group said federal regulators are sticking to their position that its Axiofill product doesn't meet regulatory requirements for a certain classification sought by the company.

The company said Wednesday that the Food and Drug Administration issued a determination letter reaffirming its position that Axiofill, a human-derived particulate wound dressing, doesn't meet the requirements of a human cell, tissue or cellular or tissue-based Product under Section 361 of the Public Health Service Act.

MiMedx has filed a lawsuit in Georgia federal court challenging the FDA's determination. It will continue to market Axiofill in the meantime.

"We are disappointed that the FDA, through the [request for designation] process, has reached a conclusion that continues an inconsistent approach to regulating Axiofill and other human-derived particulate products," Chief Executive Joseph Capper said.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

March 27, 2024 08:49 ET (12:49 GMT)

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