Berlin Heals and the C-MIC II Investigators announced publication of landmark trial results in the European Journal of Heart Failure, demonstrating the efficacy of an implantable microcurrent device for treating heart failure with reduced ejection fraction. The findings represent a major advancement in bioelectronic medicine, introducing a novel therapeutic approach for patients with advanced heart failure.
Trial Design and Patient Population
The C-MIC II study was an open-label, randomized controlled trial involving 70 ambulatory patients with non-ischemic dilated cardiomyopathy. Participants had left ventricular ejection fractions between 25-35% and NYHA Class III-IV symptoms. Patients were randomized 1:1 to receive either the Cardio-Microcurrent (C-MIC) device plus guideline-directed medical therapy or guideline-directed medical therapy alone.
The C-MIC device is a novel implantable system that delivers low-intensity microcurrent to the failing myocardium through two electrodes connected to an implantable generator that provides constant direct current across the diseased heart.
Primary Efficacy Results
At six months, patients receiving C-MIC therapy experienced markedly superior improvements across all prespecified endpoints. The primary endpoint showed left ventricular ejection fraction increased by an average of 6.6% in the C-MIC group compared to 1.5% in controls, yielding a statistically significant between-group difference of 5.1% (95% CI 3.1-7.1; p < 0.001).
Functional and Quality of Life Outcomes
The trial demonstrated consistent benefits across multiple clinical measures. Regarding functional capacity, 84% of C-MIC patients improved by at least one NYHA class compared with only 15% of controls, representing a risk difference of 68.9% (95% CI 50.6-87.2; p < 0.001).
Quality of life improvements were similarly impressive, with 75% of C-MIC patients achieving a ≥5-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score versus 15% in controls (risk difference 60.0%, 95% CI 42.3-77.6; p < 0.001).
Exercise capacity also improved significantly, with 47% of treated patients attaining at least a 30% increase in six-minute walk distance compared with only 9% of controls (risk difference 38.3%, 95% CI 14.4-62.2; p = 0.002).
Safety Profile
The therapy demonstrated a favorable safety profile throughout the six-month study period, with no device-related serious adverse events reported among participants.
Expert Commentary
"This study offers compelling evidence that microcurrent therapy can enhance both cardiac function and patient-centered outcomes in individuals with HFrEF," said Prof. Jesus E. Rame, co-first author and The Louis R. Dinon MD Professor of Medicine and Surgery at Thomas Jefferson University. "These findings introduce a promising new therapeutic avenue for patients who remain symptomatic despite receiving optimal medical therapy."
Prof. Stefan D. Anker, senior author and Professor of Cardiology at the German Heart Center Charité, noted the significance of the results: "This is the first randomized trial to demonstrate that low-level microcurrent stimulation can improve both structural heart function and quality of life. It establishes a strong foundation for future studies focused on long-term clinical outcomes."
Future Development
Berlin Heals has completed enrollment in the CMIC-III study, evaluating a less invasive approach to device implantation that could be performed by cardiologists in outpatient cardiac catheterization laboratories rather than requiring cardiothoracic surgery. This development could potentially expand access to the therapy for a broader patient population.
The company plans to pursue a pivotal FDA IDE trial as part of the FDA Breakthrough and TAP programs, with the goal of achieving regulatory and reimbursement approvals for market launch.
