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
