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- High Impact Session presented at Heart Rhythm Society’s Congress in Chicago
- First time showing results of new Less Invasive approach
- Improvement in Left Ventricular Ejection Fraction (LVEF), 6 Minute Walk Test (6MWT), Quality of Life (QOL) and New York Heart Association (NYHA) class.
CHICAGO, April 25, 2026 /PRNewswire/ — Berlin Heals Holding AG, a clinical-stage medical device company focused on transforming the treatment of heart failure (HF) with a first-in-class, durable therapy, announced the presentation of positive results from the First-In-Human (FIH) CMIC-III study. The study evaluated the safety of a novel, less invasive approach to implanting the cardiac microcurrent (CMIC) device. The data were presented by Dr. Marat Fudim, Associate Professor of Cardiology and HF at Duke University, during a High Impact Science Session at the Heart Rhythm Society’s Annual Congress in Chicago, Illinois.
This marks the first-time the CMIC system has been implanted via an outpatient procedure. The results demonstrated clinically significant improvements in LVEF, 6MWT, QOL and NYHA with a strong safety profile. Notably, these results are consistent with the robust outcomes previously observed in studies using the pericardial surgical implantation approach. To date, a total of 52 patients have been implanted across 3 studies.
"Earlier heart failure studies of microcurrent therapy demonstrated compelling clinical benefits but required a surgical implantation approach." Said Sr. Author of the study Professor William T. Abraham, M.D., College of Medicine Distinguished Professor at The Ohio State University Wexner Medical Center. "These new data from the CMIC-III study show that we can achieve comparable improvements using a less invasive, outpatient procedure, significantly enhancing the safety profile and expanding access to a much broader population of patients."
Berlin Heals has initiated Phase II of the CMIC-III less invasive FIH study. This next phase will evaluate the therapy in patients with mildly reduced left ventricular ejection fraction (LVEF >40% and <50%) expanding the clinical experience into a broader heart failure population. In parallel the company will launch the C-MIC-IV double blind sham- controlled trial, enrolling patients with both non-ischemic and ischemic heart failure and LVEF of 20-40%, primarily across Western European centers.
Together, these two studies are expected to increase the total number of implanted patients to approximately 122, generating critical data to inform the design and significantly de-risk the FDA IDE pivotal trial for market approval.
Berlin Heals Holding AG is a Swiss joint-stock company founded in 2014. The company’s C-MIC technology delivers a constant electrical microcurrent to the heart, generating a localized electrical field designed to improve cardiac function. Based on clinical studies to date, this approach has shown the potential to deliver rapid and sustained benefits for patients suffering from heart failure.
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