Berlin Heals Releases Two-Year Clinical Study Results on Cardiac Microcurrent Therapy for Heart Failure

Berlin Heals Announced Groundbreaking Findings on Cardiac Microcurrent Therapy



Berlin Heals, a leader in bioelectric medicine focusing on heart failure treatments, has recently unveiled the findings of a two-year study examining the effects of its innovative Cardiac Microcurrent Implantable Device (C-MIC). This peer-reviewed study titled Two-year outcomes of a cardiac microcurrent device in chronic heart failure: A first-in-human pilot study was published in the reputable journal ESC Heart Failure, marking a significant milestone in the way we understand cardiac interventions.

Study Overview


The primary aim of the study was to assess the long-term safety, efficacy, and durability of C-MIC therapy in patients suffering from chronic heart failure. The study revisited seven patients initially involved in a pilot trial—these individuals had an average left ventricular ejection fraction (LVEF) of 31.7% and were classified under NYHA Class III, indicating severe heart failure symptoms.

After two years of data collection following the deactivation of the device, the results were compelling. The study primarily evaluated mortality rates, hospital readmissions, adverse events associated with the device, and functional assessments of the participants.

Key Findings


1. Safety & Adverse Events


The findings were notably positive as no device-related adverse events were documented throughout the two-year follow-up period. Such results suggest a high safety profile for the C-MIC therapy, an encouraging sign for future clinical applications.

2. Sustained Improvements in Cardiac Function


The most remarkable aspect of the study was the sustained improvement in the patients' cardiac function.
  • - LVEF showed an increase from +11.6% at the six-month mark to +12.6% at the two-year follow-up, even after device activation ceased.
  • - The six-minute walk distance (6MWD) improved significantly, showing an increase of over 200 meters at six months, and maintaining a remarkable distance of +191 meters above the baseline at the two-year follow-up. This indicates improved mobility and a higher quality of life for the patients involved.

3. Quality of Life Metrics


Along with cardiac function improvements, the study reported enhancements in the NYHA functional class along with a significant rise in SF-36 quality-of-life scores, emphasizing not just survival but a better quality of life post-treatment. Remarkably, only one patient required the reactivation of their C-MIC device during this period.

Clinical Implications and Future Prospects


These groundbreaking findings are particularly significant as they indicate potentially transformative effects of C-MIC therapy in heart failure treatment. According to Prof. Dragana Kosevic, who led the study, these outcomes provide critical insights into the long-term efficacy of the treatment, especially since improvements in cardiac function were maintained even after the device was turned off, hinting at its possibility to modify the disease itself.

John Brumfield, the CEO of Berlin Heals, expressed his optimism regarding the publication of this study. He stated that these encouraging two-year results not only affirm the safety of C-MIC but also bolster confidence in its long-lasting impact as a viable treatment option for heart failure patients.

Continuing with its mission to improve treatment methods for heart failure, Berlin Heals is expanding its clinical development program, with the multicenter C-MIC III trial already underway across several European territories.

For further details on the complete publication and insights from the study, visit the ESC Heart Failure journal at this link.

It's important to note that while the C-MIC therapy shows promise, the device is still investigational and has not yet received commercial approval in any jurisdiction. Its long-term safety and effectiveness are still undergoing thorough evaluation.

As we look towards the future of heart failure treatments, the advancements being made at Berlin Heals highlight a positive shift in how patients might manage their conditions, potentially leading to better outcomes and improved lives.

Topics Health)

【About Using Articles】

You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.

【About Links】

Links are free to use.