MiMedx Group Gets FDA Warning Letter on Axiofill Classification
By Ben Glickman
MiMedx Group has received a warning letter from the U.S. Food and Drug Administration related to the classification of its product Axiofill.
The Marietta, Ga.-based company's recently-launched pacental-derived tissue products were determined by the FDA earlier this year not to meet the requirements as a Section 361 product, which don't require pre-market review.
MiMedx said it received a warning letter from the FDA on Dec. 21 reiterating this position, after the company attempted to engage with the agency. The company said it does not agree with FDA's position.
MiMedx said the letter does not relate to any other products or assert any product safety claims.
MiMedx claimed the product had been incorrectly characterized, as it is "directly comparable" at least one other product regulated under Section 361.
The company said Axiofill is expected to generate less than 5% of total sales in 2023. The company backed its previous guidance of full-year sales in the high-teens.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
December 29, 2023 17:39 ET (22:39 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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