Berlin Heals Announces Publication of Two-Year Clinical Outcomes of Cardiac Microcurrent Therapy in ESC Heart Failure

Study shows sustained improvements in heart failure symptoms and function following long-term C-MIC therapy

ZUG, Switzerland, July 16, 2025 /CNW/ -- Berlin Heals, a pioneer in bioelectric medicine for the treatment of heart failure, is pleased to announce the publication of a new peer-reviewed study titled "Two-year outcomes of a cardiac microcurrent device in chronic heart failure: A first-in-human pilot study" in the ESC Heart Failure journal.

The study presents the long-term follow-up of patients enrolled in the initial pilot trial of the Cardiac Microcurrent Implantable Device (C-MIC), designed to restore myocardial function in patients with chronic heart failure. This publication marks the first report of sustained clinical benefit following the discontinuation of active therapy—two years after initial device implantation.

Study Summary
The two-year follow-up evaluated the safety, durability, and efficacy of C-MIC therapy in seven patients with chronic heart failure (NYHA Class III, mean LVEF 31.7%). Patients who had completed the initial six-month pilot trial were reassessed for mortality, hospitalization rates, device-related adverse events, and functional status.

Key findings include:

• No device-related adverse events were reported over the two-year period.
• LVEF improvements of +11.6% at 6 months were sustained at +12.6% two years after deactivation of the device.
• 6-minute walk distance (6MWD) improved by over 200 meters at 6 months and remained nearly +191 meters above baseline at two years.
• Improvements in NYHA functional class and SF-36 quality-of-life scores were maintained.
• Only one patient required C-MIC reactivation.

"These findings offer important clinical insights into the long-term potential of C-MIC therapy," said Prof. Dragana Kosevic, the study's first author and Co-Principal Investigator. "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, CEO of Berlin Heals, added: "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."

Berlin Heals is currently expanding its clinical development program, with the multicenter C-MIC III trial now underway in several European countries.

To access the full publication in ESC Heart Failure, please visit http://doi.org/10.1002/ehf2.15369.

Media Contact:
John Brumfield
[email protected]

Disclaimer:
The C-MIC device is investigational and not approved for commercial use in any jurisdiction. Its safety and effectiveness are still under evaluation.

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SOURCE Berlin Heals Holding AG