MiMedx announced favorable interim results for EPIEFFECT in treating diabetic foot ulcers, indicating superiority over standard care.
Quiver AI Summary
MiMedx Group, Inc. has announced the publication of interim results from its CAMPAIGN trial, which is evaluating the performance of its EPIEFFECT® product against standard wound care for nonhealing diabetic foot ulcers. The interim analysis, published in the International Journal of Tissue Repair, shows a 98.5% probability of EPIEFFECT being superior to standard care based on an initial sample of 71 patients, with enrollment ongoing. The company presented expanded results from 88 patients at a recent industry summit, highlighting EPIEFFECT's clinical efficacy. CEO Joseph H. Capper expressed optimism about the study's potential and its implications for Medicare and insurance coverage amid upcoming local coverage determinations. MiMedx aims to continue its leadership in healing solutions and chronic wound management.
Potential Positives
- Publication of interim results demonstrating a 98.5% probability of EPIEFFECT's superiority over standard of care for treating nonhealing diabetic foot ulcers, highlighting its clinical effectiveness.
- Presentation at a key industry event (Tissue Research Evidence Summit) with an expanded patient sample provides further validation for EPIEFFECT's efficacy.
- Positive interim results may support future Medicare and commercial insurance coverage, potentially increasing market access for EPIEFFECT.
- MIMEDX's strong commitment to scientific and clinical efficacy reinforces its position as a leader in the wound care market, enhancing its credibility and reputation.
Potential Negatives
- The interim results are based on a relatively small sample size of 71 patients, which may limit the robustness and generalizability of the findings.
- Enrollment for the CAMPAIGN trial is still ongoing, indicating that definitive conclusions about EPIEFFECT's efficacy compared to standard of care cannot yet be made.
- There are pending Local Coverage Determinations that may affect reimbursement policies for EPIEFFECT, introducing uncertainty regarding future market access and financial performance.
FAQ
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 for wound treatment.
How does EPIEFFECT compare to standard of care?
EPIEFFECT has shown significant clinical benefit compared to standard of care, based on both real-world evidence and clinical trials.
What is the significance of the TRES presentation?
At TRES, MIMEDX presented expanded data from 88 patients, further strengthening the case for EPIEFFECT over standard of care.
When is the Local Coverage Determination for EPIEFFECT expected?
The Local Coverage Determination is scheduled for implementation on January 1, 2026, which could enhance coverage for EPIEFFECT.
How long has EPIEFFECT been on the market?
EPIEFFECT was launched in 2023 and has received positive feedback regarding its clinical efficacy in wound treatment.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
[email protected]
