03:06 PM EDT, 03/27/2024 (MT Newswires) -- MiMedx Group ( MDXG ) said Wednesday the US Food and Drug Administration affirmed that Axiofill, a human-derived particulate wound dressing, does not meet the regulatory requirements as a Human Cell, Tissue or Cellular or Tissue-based Product under Section 361 of the Public Health Service Act.

The FDA issued its decision in a determination letter following the company's request for designation.

MiMedx ( MDXG ) said it initiated legal action against the agency in the US District Court for the Northern District of Georgia and plans to explore all legal avenues, given the alleged "arbitrary and capricious manner in which FDA is regulating like-kind products.".

During the proceedings, the company intends to continue marketing Axiofill.

MiMedx ( MDXG ) said it does not expect the Axiofill issue to affect financial guidance for 2024, the company said.

The FDA didn't immediately respond to a request for comment by MT Newswires.

Shares of MiMedx ( MDXG ) fell 0.5% in recent Wednesday trading.

Price: 7.58, Change: -0.04, Percent Change: -0.52