MIMEDX Provides Update on AXIOFILL Request for Designation (“RFD”) from FDA

Receives Determination Letter from FDA Stating AXIOFILL Does Not Qualify for Classification as an HCT/P Under Section 361

MIMEDX Continues to Pursue All Available Options to Keep AXIOFILL on the Market

Reiterates Expectations for 2024 Net Sales Percentage Growth in the Low Double Digits and 2024 Adjusted EBITDA¹ Margin Above 20%

MARIETTA, Ga., March 27, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today 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”).

Joseph H. Capper, MIMEDX Chief Executive Officer, commented: “We are disappointed that the FDA, through the RFD process, has reached a conclusion that continues an inconsistent approach to regulating AXIOFILL and other human-derived particulate products. As I stated on our February conference call, we intend to exhaust all of our legal and regulatory options in an attempt to ensure continued access to this incredibly safe and effective product. Since the FDA has issued a final agency decision, we are taking steps to assert our position in court."

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.

Today, 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 we 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.