On December 29, 2023, MiMedx issued a press release announcing that “[f]ollowing 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.”
On this news, MiMedx’s stock price fell $0.90 per share, or 10.26%, to close at $7.87 per share on January 2, 2024.
