Iryna Drozd
MiMedx (NASDAQ:MDXG) said it has received a warning letter from the FDA related to production of its placental-derived tissue product Axiofill.
The biotech company said the letter relates to how the agency has classified the product and the production requirements for that classification. MiMedx said it has been “actively engaged” with the agency over the product’s designation.
MiMedx said the warning letter “does not assert any product safety claims or adverse events related to Axiofill.” It 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 commentary” on the matter during its Q4 earnings conference call in late February.
The company said that Axiofill is expected to generate less than 5% of its total net sales for 2023.
MiMedx also reiterated its 2023 net sales forecast of growth in the high teens and Q4 adjusted EBITDA margin of above 20%.
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