{"id":28392,"date":"2025-07-23T08:52:46","date_gmt":"2025-07-23T08:52:46","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/landmark-trial-demonstrates-efficacy-of-microcurrent-therapy-in-heart-failure-c-mic-ii-results-published-in-the-european-journal-of-heart-failure\/"},"modified":"2025-07-23T08:52:46","modified_gmt":"2025-07-23T08:52:46","slug":"landmark-trial-demonstrates-efficacy-of-microcurrent-therapy-in-heart-failure-c-mic-ii-results-published-in-the-european-journal-of-heart-failure-2","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=28392","title":{"rendered":"Landmark Trial Demonstrates Efficacy of Microcurrent Therapy in Heart Failure: C-MIC II Results Published in the European Journal of Heart Failure"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

ZUG, Switzerland<\/span>, July 23, 2025<\/span><\/span> \/PRNewswire\/ — Berlin Heals and the\u00a0C-MIC II Investigators today announced the publication of the\u00a0C-MIC II trial\u00a0results in the\u00a0European Journal of Heart Failure<\/i>. The study, titled\u00a0“Cardio-microcurrent Device Treatment for Heart Failure with Reduced Ejection Fraction: Results from the C-MIC II Open Label Randomized Controlled Trial,” <\/i>was previously presented as a\u00a0Late-Breaking Clinical Trial (LBCT)\u00a0at the\u00a02025 ESC-HFA Congress in Belgrade<\/span>.<\/p>\n

\u00a0<\/p>\n

The findings mark a major advancement in the field of\u00a0bioelectronic medicine\u00a0for heart failure, highlighting the potential of the\u00a0Cardio-Microcurrent (C-MIC) device\u2014a novel implantable system that delivers low-intensity microcurrent to the failing myocardium.<\/p>\n

Study Summary<\/b><\/p>\n

In this open-label, randomized controlled trial,\u00a070 ambulatory patients\u00a0with\u00a0non-ischemic dilated cardiomyopathy,\u00a0LVEF 25\u201335%, and\u00a0NYHA Class III\u2013IV\u00a0symptoms were randomized 1:1 to receive\u00a0C-MIC therapy\u00a0plus guideline-directed medical therapy (GDMT) or GDMT alone. The primary endpoint was the difference in change in LVEF at 6 months. Secondary endpoints included change in NYHA class, 6-minute walk distance (6MWD), and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS).<\/p>\n

At six months, patients receiving C-MIC therapy experienced markedly greater improvements than controls across all prespecified endpoints. Left-ventricular ejection fraction (LVEF) rose by an average of 6.6% in the C-MIC group versus 1.5% in the control group, yielding a mean between-group difference of 5.1% (95 % CI 3.1\u20137.1; p < 0.001). Clinically meaningful functional gains were similarly superior: 84 % of C-MIC patients improved by at least one NYHA class compared with 15 % of controls\u2014a risk difference of 68.9 % (95 % CI 50.6\u201387.2; p < 0.001). Quality-of-life also benefited, with 75 % of C-MIC patients achieving a \u22655-point increase in KCCQ Overall Summary Score versus 15 % in controls (risk difference 60.0 %, 95 % CI 42.3\u201377.6; p < 0.001). Finally, nearly half of treated patients (47 %) attained at least a 30 % rise in six-minute-walk distance compared with only 9 % of controls (risk difference 38.3 %, 95 % CI 14.4\u201362.2; p = 0.002), underscoring consistent benefit across structural, symptomatic, and functional outcomes. The therapy was well tolerated, with\u00a0no device-related serious adverse events\u00a0reported.<\/p>\n

Author and Investigator Quotes<\/b><\/p>\n

“This study offers compelling evidence that microcurrent therapy can enhance both cardiac function and patient-centered outcomes in individuals with HFrEF,” said Prof. Jesus E. Rame<\/span><\/b>, co-first author, The Louis R. Dinon MD Professor of Medicine and Surgery and Enterprise Chief of Advanced Cardiac and Pulmonary Vascular Disease at Thomas Jefferson University<\/span>. “These findings introduce a promising new therapeutic avenue for patients who remain symptomatic despite receiving optimal medical therapy.” Dr. Rame further noted, “This randomized controlled trial not only demonstrates the efficacy and safety of the therapy in patients with stable, chronic ambulatory heart failure, but also pioneers an entirely novel treatment paradigm aimed at restoring cardiac function in non-ischemic cardiomyopathy.”<\/p>\n

“This was a remarkable collaborative effort across all participating sites,” said Prof. Dragana N. Kosevic<\/span><\/b>, co-first author and\u00a0co-Principal Investigator\u00a0at\u00a0Dedinje Cardiovascular Institute, Belgrade<\/span>. “We observed meaningful improvements in symptoms and functional capacity among our patients\u2014an encouraging sign for broader clinical adoption.”<\/p>\n

Prof. Jan Schmitto<\/span><\/b>,\u00a0Professor of Cardiac Surgery\u00a0at the\u00a0Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, co-first author and\u00a0coordinating investigator\u00a0of the trial, commented: “These results validate more than a decade of translational work. They suggest that restoring myocardial bioelectric signaling can have a direct and clinically meaningful impact on cardiac performance in patients with advanced heart failure.”<\/p>\n

Prof. Stefan D. Anker<\/span><\/b>,\u00a0senior author\u00a0and\u00a0Professor of Cardiology\u00a0at Department of Cardiology (CVK) of German Heart Center Charit\u00e9; German Centre for Cardiovascular Research (DZHK) partner site Berlin<\/span>, Charit\u00e9 Universit\u00e4tsmedizin, Berlin<\/span> added: “This is the first randomized trial to demonstrate that low-level microcurrent stimulation can improve both structural heart function and quality of life. It establishes a strong foundation for future studies focused on long-term clinical outcomes.”<\/p>\n

“We are thrilled to see the C-MIC II results published in the European Journal of Heart Failure<\/i>,” said\u00a0John Brumfield<\/span><\/b>, CEO of Berlin Heals “These findings support our mission to develop breakthrough, bioelectronic therapies for chronic heart failure\u2014targeting the disease at its electrical and cellular roots.”<\/p>\n

To access the full publication in\u00a0European Journal of Heart Failure<\/i>, please visit https:\/\/onlinelibrary.wiley.com\/doi\/epdf\/10.1002\/ejhf.3763<\/a><\/p>\n

Disclaimer:<\/b><\/p>\n

The C-MIC device is investigational and not approved for commercial use in any jurisdiction. Its safety and effectiveness are still under evaluation.<\/i><\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

ZUG, Switzerland<\/span>, July 23, 2025<\/span><\/span> \/PRNewswire\/ — Berlin Heals and the\u00a0C-MIC II Investigators today announced the publication of the\u00a0C-MIC II trial\u00a0results in the\u00a0European Journal of Heart Failure<\/i>. The study, titled\u00a0“Cardio-microcurrent Device Treatment for Heart Failure with Reduced Ejection Fraction: Results from the C-MIC II Open Label Randomized Controlled Trial,” <\/i>was previously presented as a\u00a0Late-Breaking Clinical Trial (LBCT)\u00a0at the\u00a02025 ESC-HFA Congress in Belgrade<\/span>.<\/p>\n

\u00a0<\/p>\n

The findings mark a major advancement in the field of\u00a0bioelectronic medicine\u00a0for heart failure, highlighting the potential of the\u00a0Cardio-Microcurrent (C-MIC) device\u2014a novel implantable system that delivers low-intensity microcurrent to the failing myocardium.<\/p>\n

Study Summary<\/b><\/p>\n

In this open-label, randomized controlled trial,\u00a070 ambulatory patients\u00a0with\u00a0non-ischemic dilated cardiomyopathy,\u00a0LVEF 25\u201335%, and\u00a0NYHA Class III\u2013IV\u00a0symptoms were randomized 1:1 to receive\u00a0C-MIC therapy\u00a0plus guideline-directed medical therapy (GDMT) or GDMT alone. The primary endpoint was the difference in change in LVEF at 6 months. Secondary endpoints included change in NYHA class, 6-minute walk distance (6MWD), and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS).<\/p>\n

At six months, patients receiving C-MIC therapy experienced markedly greater improvements than controls across all prespecified endpoints. Left-ventricular ejection fraction (LVEF) rose by an average of 6.6% in the C-MIC group versus 1.5% in the control group, yielding a mean between-group difference of 5.1% (95 % CI 3.1\u20137.1; p < 0.001). Clinically meaningful functional gains were similarly superior: 84 % of C-MIC patients improved by at least one NYHA class compared with 15 % of controls\u2014a risk difference of 68.9 % (95 % CI 50.6\u201387.2; p < 0.001). Quality-of-life also benefited, with 75 % of C-MIC patients achieving a \u22655-point increase in KCCQ Overall Summary Score versus 15 % in controls (risk difference 60.0 %, 95 % CI 42.3\u201377.6; p < 0.001). Finally, nearly half of treated patients (47 %) attained at least a 30 % rise in six-minute-walk distance compared with only 9 % of controls (risk difference 38.3 %, 95 % CI 14.4\u201362.2; p = 0.002), underscoring consistent benefit across structural, symptomatic, and functional outcomes. The therapy was well tolerated, with\u00a0no device-related serious adverse events\u00a0reported.<\/p>\n

Author and Investigator Quotes<\/b><\/p>\n

“This study offers compelling evidence that microcurrent therapy can enhance both cardiac function and patient-centered outcomes in individuals with HFrEF,” said Prof. Jesus E. Rame<\/span><\/b>, co-first author, The Louis R. Dinon MD Professor of Medicine and Surgery and Enterprise Chief of Advanced Cardiac and Pulmonary Vascular Disease at Thomas Jefferson University<\/span>. “These findings introduce a promising new therapeutic avenue for patients who remain symptomatic despite receiving optimal medical therapy.” Dr. Rame further noted, “This randomized controlled trial not only demonstrates the efficacy and safety of the therapy in patients with stable, chronic ambulatory heart failure, but also pioneers an entirely novel treatment paradigm aimed at restoring cardiac function in non-ischemic cardiomyopathy.”<\/p>\n

“This was a remarkable collaborative effort across all participating sites,” said Prof. Dragana N. Kosevic<\/span><\/b>, co-first author and\u00a0co-Principal Investigator\u00a0at\u00a0Dedinje Cardiovascular Institute, Belgrade<\/span>. “We observed meaningful improvements in symptoms and functional capacity among our patients\u2014an encouraging sign for broader clinical adoption.”<\/p>\n

Prof. Jan Schmitto<\/span><\/b>,\u00a0Professor of Cardiac Surgery\u00a0at the\u00a0Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, co-first author and\u00a0coordinating investigator\u00a0of the trial, commented: “These results validate more than a decade of translational work. They suggest that restoring myocardial bioelectric signaling can have a direct and clinically meaningful impact on cardiac performance in patients with advanced heart failure.”<\/p>\n

Prof. Stefan D. Anker<\/span><\/b>,\u00a0senior author\u00a0and\u00a0Professor of Cardiology\u00a0at Department of Cardiology (CVK) of German Heart Center Charit\u00e9; German Centre for Cardiovascular Research (DZHK) partner site Berlin<\/span>, Charit\u00e9 Universit\u00e4tsmedizin, Berlin<\/span> added: “This is the first randomized trial to demonstrate that low-level microcurrent stimulation can improve both structural heart function and quality of life. It establishes a strong foundation for future studies focused on long-term clinical outcomes.”<\/p>\n

“We are thrilled to see the C-MIC II results published in the European Journal of Heart Failure<\/i>,” said\u00a0John Brumfield<\/span><\/b>, CEO of Berlin Heals “These findings support our mission to develop breakthrough, bioelectronic therapies for chronic heart failure\u2014targeting the disease at its electrical and cellular roots.”<\/p>\n

To access the full publication in\u00a0European Journal of Heart Failure<\/i>, please visit https:\/\/onlinelibrary.wiley.com\/doi\/epdf\/10.1002\/ejhf.3763<\/a><\/p>\n

Disclaimer:<\/b><\/p>\n

The C-MIC device is investigational and not approved for commercial use in any jurisdiction. Its safety and effectiveness are still under evaluation.<\/i><\/p>\n

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