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
03-27-24 0849ET