FDA rules AXIOFILL does not qualify as HCT/P; MiMedx to sue, reiterates 2024 guidance

MIMEDX GROUP, INC.

FDA determined AXIOFILL does not meet HCT/P criteria under Section 361, treating it as a 351 biologic product.
MiMedx files suit in U.S. District Court for Northern District of Georgia to challenge FDA's decision.
Company plans to continue marketing AXIOFILL while legal proceedings are ongoing.
Reiterates 2024 guidance: low double-digit net sales growth, adjusted EBITDA margin above 20%.
Acquired exclusive rights to bovine-derived collagen particulate from Regenity Biosciences for new product later in 2024.

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