Study shows sustained improvements in heart failure symptoms and function following long-termC-MIC therapy
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 theESC Heart Failurejournal.
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The study presents the long-term follow-up of patients enrolled in the initial pilot trial of theCardiac 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 SummaryThe 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 eventswere reported over the two-year period.
— LVEF improvements of +11.6% at 6 monthsweresustained at +12.6% two yearsafter deactivation of the device.
— 6-minute walk distance (6MWD)improved by over200 metersat 6 months and remained nearly+191 meters above baseline at two years.
— Improvements inNYHA functional classandSF-36 quality-of-life scoreswere maintained.
— Only one patient required C-MIC reactivation.
“These findings offer important clinical insights into the long-term potential of C-MIC therapy,” saidProf. 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 multicenterC-MIC IIItrial now underway in several European countries.
To access the full publication inESC Heart Failure, please visit http://doi.org/10.1002/ehf2.15369.
Media Contact:John Brumfieldmedia@berlinheals.de
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
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