Latest news with #JohnBrumfield
Cision Canada
16-07-2025
- Health
- Cision Canada
Berlin Heals Announces Publication of Two-Year Clinical Outcomes of Cardiac Microcurrent Therapy in ESC Heart Failure USA
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
Associated Press
18-02-2025
- Business
- Associated Press
Berlin Heals Holding AG Successfully Raises Over 7Million CHF Round for Initiating First Studies of New Less Invasive Approaches
ZUG, Switzerland, Feb. 18, 2025 /PRNewswire/ -- Berlin Heals Holding AG, a late stage MedTech start up, has developed a breakthrough method and a product for the therapy of heart failure. The product - an electronic device called C-MIC - has already successfully been tested in patients in a pilot study and recently completed enrollment in an International Multi-Center Controlled Randomized Clinical Trial for CE certification. The company will present the new data at upcoming conferences and publish the results soon. With the therapeutic method now well supported, the company is ready to test the next generation technology in less invasive implant approaches. To reach these next milestones, the company has successfully raised over CHF 7Million from investors in a recently executed financing round. This funding will support First-In-Human studies to evaluate the safety and efficacy of these new approaches to prepare for the large pivotal trial for global regulatory and reimbursement approvals. This funding will also support further development of the product and preparation for CE submission for the first-generation device. Berlin Heals Holding AG has already demonstrated the unprecedented success of its dilated cardiomyopathy therapy in a first-in-human pilot study. The company recently presented the Long-Term sustainable results of that study in a Late Breaking Clinical Trial session at the Technology and Heart Failure Therapeutics (THT) conference on February 11th in Boston and has plans to publish the results in an upcoming journal. John Brumfield, Chief Executive Officer, Berlin Heals Holding AG comments: 'We are very grateful to our internal investors that continue to support our mission to heal Heart Failure. We are also excited to welcome our new investors that have joined us on this journey. The results from our early clinical work showed strong potential for this new therapeutic approach. We are excited to share the results of our new Randomized Clinical Trial later this year. This funding round will give us the opportunity to test the method through several new less invasive approaches to determine which technique should be used in our Pivotal Trial for FDA and global market entry. Dr. Felix Baader, Chairman of the Board, Berlin Heals Holding AG comments: 'I had the pleasure of meeting several patients together with Co-Founder Marko Bagaric from our first two studies and can see the real impact our innovation has had on returning significant quality of life to them. They were so grateful to have their lives back and be active again. With this funding round, we further our progress to impact many more lives ahead.' Berlin Heals Holding AG is a Swiss joint-stock company founded in 2014. The company has developed a revolutionary implantable device called 'C-MIC' (Cardiac Microcurrent), which - by way of a constant electrical microcurrent and the ensuing electrical field - results in a sustainable and swift improvement of outcomes in heart failure patients according to recent studies.
