By Ben Glickman
Shares of MiMedx Group fell on Friday after the company received a warning letter from the Food and Drug Administration related to the classification of its product Axiofill.
The stock was down 6.5% to $8.20 in after-hours trading, which followed a 1.5% drop at the close. Shares have more than tripled this year.
The FDA sent a letter to the company Dec. 21 reaffirming its position that Axiofill products, which are pacental-derived tissue products, fails to meet the requirements of a Section 361 product, which don’t require pre-market review.
MiMedx said the products are therefore subject to enforcement as Section 351 products, which includes pre-market review.
The company expects Axiofill to generate less than 5% of its total sales in 2023.
Write to Ben Glickman at [email protected]
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