MiMedx provides update on AXIOFILL Request for Designation from FDA

MiMedx Group 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 under Section 361 of the Public Health Service Act, PHSA. Joseph 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.”