Berlin Heals Reports Positive First-in-Human Results for Less Invasive Heart Failure Device Implantation

Berlin Heals Holding AGSearch company announced positive results from its CMIC-III first-in-human study, marking a significant milestone in the development of less invasive cardiac microcurrent therapy for heart failure patients. The clinical-stage medical device company presented data demonstrating that their cardiac microcurrent (CMIC) device can be safely implanted via an outpatient procedure while maintaining therapeutic efficacy.

Study Results and Clinical Outcomes

The CMIC-III study evaluated the safety of a novel, less invasive approach to implanting the cardiac microcurrent device, representing the first time the CMIC system has been implanted via an outpatient procedure. Results presented by Dr. Marat Fudim, Associate Professor of Cardiology and Heart Failure at Duke University, during a High Impact Science Session at the Heart Rhythm Society's Annual Congress in Chicago showed clinically significant improvements across multiple endpoints.

Patients demonstrated improvements in left ventricular ejection fraction (LVEF), 6-minute walk test (6MWT), quality of life (QOL), and New York Heart Association (NYHA) class, all with a strong safety profile. These outcomes are consistent with the robust results previously observed in studies using the pericardial surgical implantation approach, indicating that the less invasive method maintains therapeutic effectiveness while potentially improving patient access.

Technology and Treatment Approach

Berlin Heals' C-MIC technology delivers a constant electrical microcurrent to the heart, generating a localized electrical field designed to improve cardiac function. The company describes this as a first-in-class, durable therapy for heart failure treatment. To date, a total of 52 patients have been implanted across three studies, providing a growing body of clinical evidence for the technology's safety and efficacy.

"Earlier heart failure studies of microcurrent therapy demonstrated compelling clinical benefits but required a surgical implantation approach," said Professor William T. Abraham, M.D., College of Medicine Distinguished Professor at The Ohio State University Wexner Medical Center and senior author of the study. "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."

Future Clinical Development

Berlin Heals has initiated Phase II of the CMIC-III less invasive first-in-human study, which 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 plans to 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. This expanded clinical program represents a comprehensive approach to validating the technology across different heart failure populations and severity levels.

Company Background

Berlin Heals Holding AGSearch company is a Swiss joint-stock company founded in 2014, focused on transforming heart failure treatment through innovative medical device technology. Based on clinical studies conducted to date, the company's microcurrent approach has shown the potential to deliver rapid and sustained benefits for patients suffering from heart failure, positioning it as a potentially significant advancement in cardiac care.