MiMedx Group (MDXG) FDA Approvals

MiMedx Group's Drug in the FDA Approval Process

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 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.

Publication - May 5,2025

• Drug: EPIFIX
• Announced Date: May 5, 2025
• Indication: Chronic wounds

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.

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.

MiMedx Group FDA Events - Frequently Asked Questions

Has MiMedx Group received FDA approval?

As of now, MiMedx Group (MDXG) has not received any FDA approvals for its therapy in the last two years.

What drugs has MiMedx Group submitted to the FDA?

In the past two years, MiMedx Group (MDXG) has reported FDA regulatory activity for EPIFIX.

What is the most recent FDA event for MiMedx Group?

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."

What conditions do MiMedx Group's current drugs treat?

Currently, MiMedx Group has one therapy (EPIFIX) targeting the following condition: Chronic wounds.