MIMEDX Provides Update on EPIEFFECT® Randomized Controlled Trial

Rhea-AI Summary

MiMedx (Nasdaq: MDXG) reported interim results from the CAMPAIGN randomized controlled trial evaluating EPIEFFECT versus standard of care (SOC) for nonhealing diabetic foot ulcers. The interim analysis (71 patients) showed a posterior probability of superiority of 98.5% against a 90% success threshold. Results were published in the International Journal of Tissue Repair and an expanded 88-patient sample was presented at TRES on Oct 30, 2025. Enrollment is ongoing and MiMedx highlighted potential relevance for pending Medicare and commercial LCD implementations effective Jan 1, 2026.

Positive

• Posterior probability of superiority: 98.5%
• Interim analysis based on 71 enrolled patients
• Published in International Journal of Tissue Repair
• Expanded 88-patient sample presented at TRES

Negative

• CAMPAIGN enrollment is ongoing; results are interim
• Primary interim evidence rests on a 71–88 patient sample
• Medicare and commercial LCDs are pending for Jan 1, 2026

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.

The study, 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 the International 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 visit www.mimedx.com.

Contact:
Matt Notarianni
Investor Relations
470-304-7291
mnotarianni@mimedx.com

FAQ

What did MiMedx announce about the CAMPAIGN trial for EPIEFFECT (MDXG) on Nov 13, 2025?

MiMedx announced an interim CAMPAIGN RCT analysis showing a 98.5% posterior probability that EPIEFFECT is superior to standard of care.

How many patients were included in the CAMPAIGN interim analysis for MDXG's EPIEFFECT?

The interim analysis was based on 71 enrolled patients, with an expanded 88-patient set presented at TRES.

Was the CAMPAIGN interim result for MDXG published or presented publicly?

Yes — interim results were published in the International Journal of Tissue Repair and presented at TRES on Oct 30, 2025.

Do MiMedx's CAMPAIGN results guarantee Medicare coverage for EPIEFFECT (MDXG)?

No — the company said results support coverage arguments, but LCD implementations are pending and not yet in effect.

Is the CAMPAIGN trial for EPIEFFECT (MDXG) complete and final?

No — the release states enrollment is ongoing and the reported findings are interim.