Less Invasive Microcurrent Cardiac Device Improves Heart Failure Outcomes

Early microcurrent therapies showed benefits but required a surgical implantation route, limiting their use. A new device now offers a less invasive, outpatient implantation approach with clinically significant improvements reported across functional capacity, quality of life, and New York Heart Association class.

Berlin Heals Holding AG reported late-breaking results for its cardiac microcurrent (CMIC) system from the First-In-Human (FIH) CMIC-III “less invasive” study, presented on April 24, 2026, during a High Impact Science Session at the Heart Rhythm Society Annual Congress in Chicago. The company’s C-MIC technology delivers a constant electrical microcurrent to the heart, generating a localized electrical field designed to improve cardiac function. The CMIC-III study assessed the safety of the novel, less invasive outpatient technique. This marks the first time the system has been implanted as an outpatient procedure. To date, 52 patients have received the therapy across three studies.

Results demonstrated clinically significant improvements in left ventricular ejection fraction (LVEF), 6-minute walk test (6MWT), quality of life (QOL), and New York Heart Association (NYHA) functional class, alongside a strong safety profile. The findings were consistent with outcomes previously reported with the pericardial surgical implantation approach. The outpatient strategy maintained the clinical benefits while reducing procedural invasiveness.

Phase II of the CMIC-III less invasive FIH study has begun, evaluating patients with mildly reduced LVEF greater than 40% and less than 50%. In parallel, the C-MIC-IV double-blind, sham-controlled trial will enroll patients with non-ischemic and ischemic heart failure with LVEF of 20–40%, primarily at centers in Western Europe. Together, these studies are expected to bring the total number of implanted patients to approximately 122 and generate data to inform the design and significantly de-risk an FDA Investigational Device Exemption (IDE) pivotal trial for market approval.

“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,” added Professor Abraham.

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