MiMedx Group, Inc. announced that the U.S. Food and Drug Administration (?FDA?) has issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing. In the letter, FDA reaffirmed its position that AXIOFILL does not meet the regulatory classification requirements of a Human Cell, Tissue or Cellular or Tissue-based Product (?HCT/P?) under Section 361 of the Public Health Service Act (?PHSA?). In response to the RFD determination letter, the Company has filed suit in the U.S. District Court for the Northern District of Georgia and intends to exhaust all legal options available, given the arbitrary and capricious manner in which FDA is regulating like-kind products.

Notably, while these proceedings are taking place, the Company plans to continue marketing AXIOFILL. There are at least three nearly identical products, including AXIOFILL, that are treated differently by FDA. The first of these products received an RFD designation classifying it as a 361 product, consistent with other HCT/Ps.

Based on this precedent, MIMEDX introduced AXIOFILL in September 2022, also as a 361 product. As company now know, the FDA has taken a position that AXIOFILL is designated as a 351 biologic product, requiring the most time-consuming and expensive path to approval. Further confusing the matter, a third human-derived particulate product recently received 510(k) clearance, a regulatory pathway typically used for medical devices, including xenografts and synthetic products.