---
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"
generated_at: "2026-06-04T07:02:31.984483+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001376339-24-000026
- JSON: https://secwatch.observer/filing/0001376339-24-000026.json
- Plain text: https://secwatch.observer/filing/0001376339-24-000026.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.