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MIMEDX Provides AXIOFILL® Update & Reiterates 2023 Full Year Net Sales and Fourth Quarter Adjusted EBITDA Margin Outlook
Receipt of FDA Warning Letter for AXIOFILL Classification; Not Related to Safety Request for Designation for AXIOFILL Submitted to FDA and Currently Under
About this update from Mimedx Group, Inc
[{"type":"text","content":"Receipt of FDA Warning Letter for AXIOFILL Classification; Not Related to Safety Request for Designation for AXIOFILL Submitted to FDA and Currently Under Review Reiterates Expectations for 2023 Net Sales Growth in the High Teens and Fourth Quarter Adjusted EBITDA Margin of Above 20% MARIETTA, Ga., Dec. 29, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today provided the following update regarding AXIOFILL and reiterated its outlook for 2023 full year net sales growth and fourth quarter adjusted EBITDA margin. AXIOFILL Update Following a routine inspection earlier in the year, the United States Food and Drug Administration (“FDA”) took the position that one of the Company’s recently-launched placental-derived tissue products – AXIOFILL – does not meet the requirements as a Section 361 product and is therefore subject to enforcement as a Section 351 product. Specifically, FDA asserts that the production of AXIOFILL involves more than “minimal manipulation.” The Company does not agree with FDA’s position and has been actively engaged with the agency through its “Request For Designation” (“RFD”) process. However, on December 21, 2023, MIMEDX received a Warning Letter from FDA reiterating the agency’s position on AXIOFILL. The Warning Letter does not relate to any of the Company’s other products, nor does it assert any product safety claims or adverse events related to AXIOFILL. AXIOFILL has been on the market since September 2022 and has a strong safety record. The Company believes that AXIOFILL, which is expected to generate less than 5% of MIMEDX’s total net sales anticipated for 2023, was developed and is manufactured to comply with the requirements for a Human Cell, Tissue or Cellular or Tissue-based Product (“HCT/P”) under Section 361 of the Public Health Service Act. Specifically, AXIOFILL is composed solely of human placental disc extracellular matrix (ECM)AXIOFILL is used to “replace or supplement damaged or inadequate integumental tissue” which is consistent with ECM homologous use. AXIOFILL’s product characteristics can be reasonably considered directly comparable to at least one other commercially available HCT/P on the market that the FDA regulates under Section 361 and, as a result, the Company believes FDA is not consistently applying the rules for permitted use. Joseph H. Capp...