MiMedx reports US FDA warning letter for Axiofill, shares drop (updated)

MiMedx

29/12/2023 23:58

(Adds shares in paragraph 2, details throughout)
       Dec 29 (Reuters) - MiMedx Group  MDXG.O  said on Friday
it had received a warning letter from the U.S. Food and Drug
Administration related to the classification of its
placental-derived tissue product Axiofill, and its shares fell
7% after the bell.
        MiMedx said the letter, which it received last week, was
not related to a safety issue.
  
        Axiofill, a human placental-derived product, was
launched in September last year for surgical recovery
procedures. 
  
        FDA asserted the production of Axiofill involves more
than "minimal manipulation", the company said. It said it
disagrees with the health regulator's stance.
  
        Following a routine inspection this year, the FDA found
Axiofill does not fall under Section 361 of the U.S. Public
Health Service Act. Instead, the regulator said Axiofill should
be under Section 351, which regulates products as biologics that
require premarket approval. Human tissues, in contrast, are
regulated under section 361, where the primary safety concern is
infectious disease transmission.
        MiMedx said the product was developed and is
manufactured to comply with the requirements of section 361. It
is used to "replace or supplement damaged or inadequate
integumental tissue", it said.
  
        Axiofill, is expected to generate less than 5% of the
company's total net sales anticipated for 2023.
  
        The company said it has been working with the FDA and
will provide updates regarding the matter in late-February.
  

 (Reporting by Sriparna Roy in Bengaluru; Editing by Shounak
Dasgupta and David Gregorio)
 ((Sriparna.Roy@thomsonreuters.com))