MiMedx falls on FDA warning letter for its placental-derived Axiofill

MiMedx

02/01/2024 15:11

** Shares of Georgia-based biotech company MiMedx Group
 MDXG.O  fall 11% to $7.80
    ** Co said on Friday it received a warning letter from the
U.S. Food and Drug Administration related to the classification
of Axiofill, a human placental-derived product
    ** The FDA said Axiofill does not meet the requirements as a
Section 361 product, under which human tissue-based products are
reviewed and regulated
    ** U.S. health agency says Axiofill falls under Section 351
of the Public Health Service Act, which regulates products such
as biologics that require premarket approval
    ** MDXG said that it disagrees with the FDA's stance and
that Axiofill was developed and manufactured to comply with the
requirements for a human cell or tissue-based product
    ** Axiofill was launched in September 2022 for surgical
recovery procedures
    ** Shares of MDXG fell ~54% in 2023 

 (Reporting by Sneha  S K)
 ((Sneha.SK@thomsonreuters.com;))