FDA Events for MiMedx Group (MDXG)
This section highlights FDA-related milestones and regulatory updates for drugs developed by MiMedx Group (MDXG).
Over the past two years, MiMedx Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EPIFIX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EPIFIX - FDA Regulatory Timeline and Events
EPIFIX is a drug developed by MiMedx Group for the following indication: Chronic wounds.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EPIFIX
- Announced Date:
- May 5, 2025
- Indication:
- Chronic wounds
Announcement
MiMedx Group, Inc. announced the publication of its health economics data for reconstruction of cutaneous wounds with EPIFIX® (Dehydrated Human Amnion Chorion Membrane, or DHACM) following Mohs surgery.
AI Summary
MiMedx Group, Inc. recently announced the publication of its health economics data on using EPIFIX® (Dehydrated Human Amnion Chorion Membrane, or DHACM) for the reconstruction of cutaneous wounds following Mohs surgery. The study, which appears in the May 2025 issue of the Journal of Drugs in Dermatology, compared EPIFIX to traditional autologous tissue-based repair methods.
The research analyzed 429 patients and found that 97.2% of those treated with EPIFIX experienced no complications, compared to 78.7% with standard techniques. In addition, wounds closed faster with EPIFIX, with an average length of care of 33.3 days versus 48.3 days for conventional methods. These results suggest that using placental allografts like EPIFIX may lower the risks and costs associated with postoperative complications, offering a promising alternative for patients following Mohs surgery.
Read Announcement
MiMedx Group FDA Events - Frequently Asked Questions
As of now, MiMedx Group (MDXG) has not received any FDA approvals for its therapy in the last two years.
In the past two years, MiMedx Group (MDXG) has reported FDA regulatory activity for EPIFIX.
The most recent FDA-related event for MiMedx Group occurred on May 5, 2025, involving EPIFIX. The update was categorized as "Publication," with the company reporting: "MiMedx Group, Inc. announced the publication of its health economics data for reconstruction of cutaneous wounds with EPIFIX® (Dehydrated Human Amnion Chorion Membrane, or DHACM) following Mohs surgery."
Currently, MiMedx Group has one therapy (EPIFIX) targeting the following condition: Chronic wounds.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:MDXG) was last updated on 7/10/2025 by MarketBeat.com Staff
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