Recent Updates
Recently added Catalysts
MDXG Positive Sentiment

MIMEDX Provides Update on EPIEFFECT® Randomized Controlled Trial

Key Takeaway: MiMedx Group, Inc. announced positive interim results from its CAMPAIGN trial evaluating EPIEFFECT for diabetic foot ulcers. The trial shows a 98.5% probability that EPIEFFECT outperforms standard of care. Enrollment is ongoing, and the results may influence Medicare coverage decisions set for January 2026.
Price reaction · baseline $7.48 (2025-11-12 close) · hit pre-market · clean, no other MDXG news in the window
day 0 close
-0.1%

Market Sentiment Analysis

POSITIVE FACTORS

  • Interim results show EPIEFFECT has a 98.5% probability of superiority over SOC.
  • Ongoing enrollment suggests continued interest and potential for robust data.
  • Positive feedback from the clinical community supports EPIEFFECT's efficacy.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~40 mo
Low dilution risk
Lead asset
Micronized DHACM
Phase 3 · Tendonitis;Achilles

Full Press Release Details

Publication of Interim Results and Presentation at Recent Industry Event Demonstrate Clinical Benefit Associated with Use of EPIEFFECT When Compared to Standard of Care (“SOC”)
Publication Adds to Large Compendium of Evidence for MIMEDX’s Leading Product Portfolio
Trial Enrollment Ongoing
MARIETTA, Ga., Nov. 13, 2025 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced the publication of interim results from its CAMPAIGN trial, a randomized controlled trial (“RCT”) designed to evaluate the performance of the Company’s EPIEFFECT®product in comparison to standard of care (“SOC”) wound treatment.
Thestudy, entitled “Evaluation of lyophilized human amnion/chorion membrane (“LHACM”) in the management of nonhealing diabetic foot ulcers: an interim analysis of the CAMPAIGN trial,” was recently published in theInternational Journal of Tissue Repair.Enrollment for CAMPAIGN is still ongoing; however, advanced predictive models indicate superiority of MIMEDX’s EPIEFFECT over SOC based upon 71 enrolled patients. The Company also presented at the Tissue Research Evidence Summit (“TRES”) in New Orleans, La. on October 30, 2025 with an expanded 88 patient sample set, further widening the gap between EPIEFFECT and SOC.
In the CAMPAIGN study design, success was defined as a posterior probability > 90%, and the interim results demonstrated the posterior probability that LHACM was superior to standard of care was 98.5%.
“Since its launch in 2023, EPIEFFECT has garnered significant praise for its clinical efficacy and utility. Until now, this has been based solely upon real-world evidence. We are, therefore, extremely pleased with the favorable results being demonstrated in this latest RCT. Thus far, EPIEFFECT recipients outperformed those treated with SOC, and we are optimistic that this study will have a successful read out upon completion,” stated Joseph H. Capper, MIMEDX Chief Executive Officer.
“MIMEDX’s ongoing commitment to demonstrating the scientific and clinical efficacy of our product portfolio once again shines through in this interim analysis. We believe the results present a compelling case for Medicare and commercial insurance coverage for this product, particularly in light of pending Local Coverage Determination (“LCD”) implementations, scheduled for January 1, 2026. To that end, we believe our EPIEFFECT study results presented at TRES stood out as having met the current criteria for inclusion under the LCDs,” concluded Mr. Capper.

About MIMEDX

MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX provides a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visitwww.mimedx.com.

Contact:Matt NotarianniInvestor Relations470-304-7291mnotarianni@mimedx.com

Frequently Asked Questions

What are the interim results of the CAMPAIGN trial?

The interim results indicate a 98.5% probability that EPIEFFECT is superior to standard of care.

How many patients are enrolled in the CAMPAIGN trial?

Currently, 71 patients are enrolled, with ongoing enrollment expected to increase this number.

What is the significance of the TRES presentation?

The presentation at TRES showcased an expanded sample set of 88 patients, reinforcing EPIEFFECT's efficacy.

When is the Local Coverage Determination expected?

The Local Coverage Determination is scheduled for implementation on January 1, 2026.

Last updated: Nov 13, 2025