Berlin Heals Publishes Promising Two-Year Results on Heart Therapy

Berlin Heals has published a significant study demonstrating the long-term effectiveness of its innovative Cardiac Microcurrent Implantable Device (C-MIC) in treating chronic heart failure. The peer-reviewed research, titled “Two-year outcomes of a cardiac microcurrent device in chronic heart failure: A first-in-human pilot study,” appears in the prestigious journal ESC Heart Failure. This study marks a critical milestone in chronic heart failure treatment, as it confirms sustained improvements in patients’ heart function and overall health following the discontinuation of the therapy.

The research focused on a cohort of seven patients diagnosed with chronic heart failure, specifically NYHA Class III, with a mean left ventricular ejection fraction (LVEF) of 31.7%. These patients had previously participated in a six-month pilot trial of the C-MIC device and were evaluated two years after the device had been deactivated. The follow-up assessed several key outcomes, including mortality rates, hospitalization, device-related adverse events, and functional status.

Key findings from the study are promising: patients experienced no device-related adverse events throughout the two-year period. Remarkably, the LVEF improvements observed at six months, which stood at +11.6%, were maintained, showing an increase of +12.6% two years post-therapy. Additionally, the six-minute walk distance (6MWD) improved by over 200 meters at six months and remained nearly +191 meters above baseline after two years. Improvements in the New York Heart Association (NYHA) functional class and the SF-36 quality-of-life scores were also sustained.

Prof. Dragana Kosevic, the study’s first author and Co-Principal Investigator, highlighted the significance of these results. “These findings offer important clinical insights into the long-term potential of C-MIC therapy,” she stated. “What’s most encouraging is that the improvements in cardiac function and patient well-being were sustained even after the device was deactivated, suggesting a disease-modifying effect.”

John Brumfield, the CEO of Berlin Heals, expressed his enthusiasm regarding the study’s implications. “The publication of this study reinforces our confidence in microcurrent therapy as a transformative treatment for heart failure. These two-year results validate both the safety and long-lasting impact of C-MIC and set the stage for larger clinical trials.”

Currently, Berlin Heals is expanding its clinical development program, with the multicenter C-MIC III trial underway across several European countries. The company aims to further establish the efficacy of its innovative therapy in broader patient populations.

For those interested in exploring the full study, it is accessible in ESC Heart Failure at the following link: http://doi.org/10.1002/ehf2.15369. It is important to note that the C-MIC device remains investigational and has not yet received approval for commercial use in any jurisdiction, with its safety and effectiveness still under evaluation.

As the field of heart failure treatment evolves, studies like these illuminate the potential for new therapies to enhance patient outcomes and reshape the landscape of cardiac care.