MIMEDX Provides Update on EPIEFFECT® Randomized Controlled Trial
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.
MiMedx (Nasdaq: MDXG) ha comunicato i risultati intermedi dall' trial CAMPAIGN, randomizzato e controllato, che valuta EPIEFFECT rispetto alla pratica standard (SOC) per le ulcere del piede diabetiche non guarite. L'analisi intermedia (71 pazienti) ha mostrato una probabilità posteriore di superiorità del 98,5% rispetto a una soglia di successo del 90%. I risultati sono stati pubblicati sull'International Journal of Tissue Repair e un campione ampliato di 88 pazienti è stato presentato al TRES il 30 ottobre 2025. Il reclutamento è in corso e MiMedx ha evidenziato la potenziale rilevanza per le prossime implementazioni LCD di Medicare e per le coperture commerciali efficaci dal 1 gennaio 2026.
MiMedx (Nasdaq: MDXG) reportó resultados interinos del ensayo CAMPAIGN, aleatorizado y controlado, que evalúa EPIEFFECT frente a la atención estándar (SOC) para úlceras diabéticas del pie que no sanan. El análisis interino (71 pacientes) mostró una probabilidad posterior de superioridad del 98,5% frente a un umbral de éxito del 90%. Los resultados fueron publicados en el International Journal of Tissue Repair y se presentó una muestra ampliada de 88 pacientes en TRES el 30 de octubre de 2025. El reclutamiento continúa y MiMedx destacó la relevancia potencial para las próximas implementaciones LCD de Medicare y para las coberturas comerciales a partir del 1 de enero de 2026.
MiMedx (나스닥: MDXG)가 EPIEFFECT를 표준 치료(SOC)와 비교해 당뇨 발의 비회복 궤양에 대한 CAMPAIGN 무작위 대조 시험의 중간 결과를 발표했습니다. 중간 분석(71명 환자)에서 우월성의 뒤확률 98.5%이 관찰되었고, 성공 임계치인 90%를 상회했습니다. 결과는 International Journal of Tissue Repair에 게재되었고, 88명의 확대한 표본은 2025년 10월 30일 TRES에서 발표되었습니다. 모집은 계속되며 MiMedx는 2026년 1월 1일 발효 예정인 Medicare 및 상업적 LCD 이행의 잠재적 관련성을 강조했습니다.
MiMedx (Nasdaq : MDXG) a communiqué les résultats intermédiaires de l'essai CAMPAIGN, randomisé et contrôlé, évaluant EPIEFFECT par rapport à la norme de soins (SOC) pour les ulcères du pied diabétique non cicatrisants. L'analyse intermédiaire (71 patients) a montré une probabilité posteriori de supériorité de 98,5% par rapport à un seuil de succès de 90%. Les résultats ont été publiés dans l'International Journal of Tissue Repair et un échantillon élargi à 88 patients a été présenté au TRES le 30 octobre 2025. Le recrutement se poursuit et MiMedx a souligné la pertinence potentielle pour les prochaines mises en œuvre LCD de Medicare et pour les couvertures commerciales à partir du 1er janvier 2026.
MiMedx (Nasdaq: MDXG) berichtete Zwischenergebnisse aus der CAMPAIGN-Studie, einer randomisierten kontrollierten Untersuchung, die EPIEFFECT im Vergleich zur Standardversorgung (SOC) für nicht heilende diabetische Fußulzera bewertet. Die Zwischenanalyse (71 Patienten) zeigte eine posterior probability of superiority von 98,5% gegenüber einer Erfolgsschwelle von 90%. Die Ergebnisse wurden im International Journal of Tissue Repair veröffentlicht und eine erweiterte Stichprobe von 88 Patienten wurde am 30.10.2025 beim TRES vorgestellt. Die Rekrutierung läuft weiter, und MiMedx hob die potenzielle Relevanz für kommende Medicare- sowie kommerzielle LCD-Implementierungen hervor, die ab dem 1. Januar 2026 in Kraft treten.
MiMedx (بورصة ناسداك: MDXG) أعلنت عن نتائج مُؤشّريّة من تجربة CAMPAIGN العشوائية المُضبوطة التي تقيم EPIEFFECT مقابل الرعاية القياسية (SOC) لقرح القدم السكري غير المشفوعة. أظهرت التحليلات الوسيطة (64 مريضًا؟ 71) احتمالية تفوق خلفية بنسبة 98.5% مقارنة بعتبة نجاح قدرها 90%. نُشرت النتائج في International Journal of Tissue Repair وتم تقديم عينة موسعة من 88 مريضًا في TRES في 30 أكتوبر 2025. التوظيف جارٍ وأبرزت MiMedx الصلة المحتملة لتطبيقات Medicare المرتقبة والتغطيات التجارية LCD implementations effective Jan 1, 2026.
- 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
- 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
Insights
Interim RCT data show strong statistical signal favoring EPIEFFECT versus standard care; reimbursement implications are timely.
MIMEDX reports an interim randomized controlled trial result where the posterior probability that EPIEFFECT (LHACM) is superior to standard of care reached
The clinical mechanism is straightforward: a randomized comparison of LHACM versus SOC in nonhealing diabetic foot ulcers produced a posterior probability well above the prespecified target, which implies observed outcome differences favor EPIEFFECT in the enrolled cohort. Key dependencies include final trial size and protocol-prespecified analysis rules, complete follow-up for all randomized patients, and peer-review details such as endpoint definitions and missing-data handling. The company cites expanded interim samples (88 patients) and predictive modeling based on 71 patients; those differing denominators should be clarified before extrapolating broadly.
Concrete items to watch on a short timeline: full CAMPAIGN enrollment completion and final readout (timing unspecified), peer-reviewed publication details and supplementary tables showing absolute effect sizes and confidence intervals, and the
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 >
“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?
How many patients were included in the CAMPAIGN interim analysis for MDXG's EPIEFFECT?
Was the CAMPAIGN interim result for MDXG published or presented publicly?
Do MiMedx's CAMPAIGN results guarantee Medicare coverage for EPIEFFECT (MDXG)?
Is the CAMPAIGN trial for EPIEFFECT (MDXG) complete and final?
