Berlin Heals Publishes Groundbreaking Two-Year Study on Cardiac Microcurrent Therapy for Heart Failure

Berlin Heals Publishes Groundbreaking Two-Year Study



Berlin Heals, a leader in bioelectric medicine aimed at treating heart failure, has announced significant advancements in cardiac therapy with the recent publication of a two-year clinical study. This peer-reviewed research, titled "Two-year outcomes of a cardiac microcurrent device in chronic heart failure: A first-in-human pilot study," was featured in the prestigious ESC Heart Failure journal.

Study Overview


The study highlights the long-term follow-up of patients who participated in an initial pilot trial of the Cardiac Microcurrent Implantable Device (C-MIC). Designed to enhance myocardial function in individuals with chronic heart failure, this research stands out as the first report demonstrating lasting clinical benefits even after active therapy was stopped two years post-implantation.

Conducted on seven participants with chronic heart failure categorized under NYHA Class III and an average left ventricular ejection fraction (LVEF) of 31.7%, the two-year follow-up scrutinized the safety, durability, and overall efficacy of the C-MIC therapy. Patients underwent evaluations for mortality, hospitalization rates, device-associated adverse events, and functional health status after completing the six-month initial trial.

Key Findings


A plethora of encouraging outcomes emerged from the study, including:
  • - No device-related adverse events were reported throughout the two-year duration.
  • - Improvement in LVEF of +11.6% at the six-month mark was notably sustained at +12.6% two years after deactivation of the device.
  • - The six-minute walk distance (6MWD) showed remarkable enhancement, improving by over 200 meters at six months and remaining nearly +191 meters above the baseline at two years.
  • - Enhancements in NYHA functional classifications, coupled with sustained SF-36 quality-of-life scores, underscored the benefits of the treatment. Remarkably, only one individual required reactivation of the C-MIC.

Insights from the Research Team


According to Prof. Dragana Kosevic, the principal investigator of the study, these findings illuminate the long-term potential of C-MIC therapy. The most striking aspect is that improvements in cardiac performance and overall patient health persisted even after the device was turned off, hinting at a potential disease-modifying effect.

John Brumfield, CEO of Berlin Heals, expressed enthusiasm over the publication, asserting that the results bolster their confidence in microcurrent therapy as a revolutionary treatment for heart failure. The data not only validate the safety but also confirm the lasting impact of the C-MIC, establishing groundwork for future extensive clinical trials.

Berlin Heals is actively expanding its clinical development pipeline, with the multicenter C-MIC III trial currently progress across several European nations.

For those interested in exploring the full details, the publication is accessible at ESC Heart Failure Journal.

Disclaimer


It is essential to note that the C-MIC device remains investigational and is not authorized for commercial use across any jurisdiction, with safety and efficacy still undergoing evaluation.

Topics Health)

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