Iryna Drozd
MyMedx (NASDAQ:MDXG) said it received a warning letter from the FDA related to the production of its placenta-derived tissue product Axiofill.
The biotech company said the letter relates to how the agency classified the product and production requirements. for that classification. MiMedx said it has been “actively engaged” with the agency on the product designation.
MiMedx said the warning letter “does not make any product safety claims or adverse events related to Axiofill.” He noted that Axiofill has been on the market since September 2022 and “has a strong safety record.”
The company plans to respond to the warning letter within the required 15-day period and “provide comment” on the matter during its fourth-quarter earnings conference call in late February.
The company said Axiofill is expected to generate less than 5% of its total net sales by 2023.
MiMedx also reiterated its 2023 net sales forecast of growth in the teens and a fourth-quarter adjusted EBITDA margin above 20%.
