MiMedx Group, Inc. announced the publication of interim results from its CAMPAIGN randomized controlled trial (RCT) for EPIEFFECT, the company’s flagship product for treating non‑healing diabetic foot ulcers. The study was published in the International Journal of Tissue Repair and represents the first randomized evidence for EPIEFFECT, which was launched in 2023.
The interim analysis, based on 71 enrolled patients, achieved a 98.5% posterior probability of superiority over standard of care, surpassing the 90% success threshold defined in the study design. An expanded data set of 88 patients was presented at the Tissue Research Evidence Summit on October 30 2025, further widening the evidence gap between EPIEFFECT and conventional treatments.
These findings are material because they provide robust clinical evidence that could support Medicare coverage decisions and strengthen MiMedx’s position in a market where evidence‑based reimbursement is increasingly critical. CEO Joseph H. Capper emphasized that the results present a compelling case for Medicare and commercial insurance coverage, particularly with Local Coverage Determination (LCD) implementations scheduled for January 1 2026.
MiMedx’s broader financial health underpins its investment in clinical trials. In the third quarter of 2025, the company reported revenue of $114 million, up 35% year‑over‑year, and an adjusted EBITDA margin of 31%. Net cash stood at $124 million, giving MiMedx the resources to pursue further evidence generation and market expansion.
The trial’s success aligns with MiMedx’s strategy to transition from real‑world evidence to RCT data, enhancing credibility with payers and clinicians. The 98.5% probability of superiority indicates strong efficacy, which could accelerate reimbursement decisions and drive future sales growth.
Overall, the interim results position MiMedx to potentially secure Medicare coverage for EPIEFFECT, creating a tailwind for the wound‑care market and reinforcing the company’s growth trajectory.
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