{"schema_version":"secwatch.filing_event.v1","accession":"0001376339-24-000026","form_type":"8-K","ticker":"MDXG","cik":"0001376339","company_name":"MIMEDX GROUP, INC.","filed_at":"2024-03-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:23.994588+00:00","generated_at":"2026-06-04T07:02:31.984483+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA rules AXIOFILL does not qualify as HCT/P; MiMedx to sue, reiterates 2024 guidance","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001376339-24-000026","json":"https://secwatch.observer/filing/0001376339-24-000026.json","markdown":"https://secwatch.observer/filing/0001376339-24-000026.md","text":"https://secwatch.observer/filing/0001376339-24-000026.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1376339/000137633924000026/0001376339-24-000026-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1376339/000137633924000026/mdxg-20240327.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T07:02:31.984483+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}