Berlin Heals' Microcurrent Device Aims to Reverse Heart Failure

ZUG, SWITZERLAND – February 12, 2026 – Swiss MedTech firm Berlin Heals Holding AG has secured over $10 million in a new financing round, signaling strong investor confidence in its novel approach to treating one of the world's most persistent and debilitating chronic conditions: heart failure. The funding will accelerate the development of its C-MIC (Cardiac Microcurrent) device, an implantable technology that aims not just to manage symptoms, but to potentially reverse the underlying damage of the disease.

The capital, raised from a mix of existing shareholders and new investors, is earmarked for a critical new phase of innovation. The company plans to expand its clinical trial program, develop less invasive implantation techniques, and take decisive steps toward global commercialization, including preparing for a pivotal Investigational Device Exemption (IDE) submission to the U.S. Food and Drug Administration (FDA).

A Gentle Current to Mend a Failing Heart

At the core of the company's strategy is the C-MIC system, a technology that stands apart in the crowded field of cardiac devices. Unlike pacemakers or defibrillators that deliver electrical pulses to regulate heart rhythm, C-MIC delivers a constant, low-level electrical microcurrent directly to the heart muscle. This creates a localized electrical field intended to improve cardiac function and stimulate tissue regeneration. Berlin Heals suggests this may be one of the first technologies capable of actually reversing heart failure, a claim supported by increasingly robust clinical data.

Results from the company's C-MIC II randomized controlled trial, presented at the 2025 European Society of Cardiology's Heart Failure Association (ESC-HFA) Congress, were particularly striking. The study, which enrolled 70 patients with non-ischaemic dilated cardiomyopathy, compared C-MIC therapy combined with standard medical treatment against standard treatment alone.

After six months, the C-MIC group showed remarkable improvements. Their left ventricular ejection fraction (LVEF), a key measure of the heart's pumping power, improved by a mean difference of 5.1% over the control group. Furthermore, 84% of patients receiving the therapy improved by at least one New York Heart Association (NYHA) functional class—a standard for classifying symptom severity—compared to just 15% in the control group.

These clinical metrics translated into tangible quality-of-life benefits. Three-quarters of the C-MIC patients reported a significant improvement in their Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Functional capacity also saw a major boost, with nearly half of the treated patients increasing their six-minute walk distance (6MWD) by at least 30%, a feat achieved by only 9% of the control group. These results build on an earlier first-in-human pilot study where patients nearly doubled their walking distance within two weeks, and the benefits were sustained over a two-year follow-up period, even after the device was deactivated. Critically, across these studies, the therapy has been well-tolerated with no device-related serious adverse events reported.

From Surgery to Catheter: The Next Frontier

While the clinical efficacy is promising, Berlin Heals is acutely aware that the invasiveness of a procedure can be a major barrier to adoption for both patients and physicians. The company's latest funding will heavily support the C-MIC III study, which is evaluating a new, less invasive implantation technique. The goal is to transform the procedure from an open surgical operation requiring general anesthesia into a more streamlined process that can be performed in an outpatient cardiac catheterization lab.

This strategic shift aligns with a dominant trend in cardiology, where transcatheter-based therapies like Abbott's MitraClip for valve repair have revolutionized treatment by offering effective, less burdensome alternatives to open-heart surgery. By pursuing a similar path, Berlin Heals aims to significantly broaden the eligible patient population, reduce recovery times, and make its therapy more accessible to hospitals and clinicians who may not have the resources for complex surgical interventions. Topline data from this first-in-human study of the less invasive approach are anticipated later in 2026.

John Brumfield, Chief Executive Officer of Berlin Heals, emphasized the importance of this new phase. "Closing this financing round marks an important milestone for us," he stated in the company's announcement. "Having this strong background and support, together with our clinical data, we now have even more confidence to move into less invasive solutions that could significantly expand the impact of our therapy. This funding allows us as well to take decisive steps toward global commercialization."

Investor Confidence and the Path to Market

The investment comes at a pivotal time, as the global market for heart failure devices is projected to surge, with some estimates suggesting it could exceed $40 billion by 2032. This lucrative landscape is currently dominated by MedTech giants such as Medtronic, Abbott, and Boston Scientific, whose devices primarily focus on cardiac rhythm management and mechanical circulatory support.

Berlin Heals is positioning C-MIC as a disruptive technology in this established market. Its focus on functional recovery and potential disease reversal offers a different value proposition compared to devices that manage symptoms or provide end-stage support. The recent funding, secured with the help of Co-Founder and Board Member Marko Bagaric, validates this unique approach and provides the necessary capital to challenge the incumbents.

The company's strategy is bolstered by strong regulatory tailwinds in the United States. The C-MIC system has already received Breakthrough Device Designation from the FDA, a status reserved for technologies that may provide more effective treatment for life-threatening or irreversibly debilitating conditions. It was also selected for the FDA's Total Product Life Cycle Advisory Program (TAP), both of which are designed to expedite development and review cycles, potentially shortening the path to market.

Rob ten Hoedt, Board Chairman of Berlin Heals, commented on the technology's potential to shift the treatment paradigm. "Heart failure remains an area of tremendous unmet medical need," he said. "Having followed the growth of Berlin Heals, I am convinced that this technology has the potential to redefine how we treat heart failure patients. This financing enables the company to translate its innovation into a therapy that can reach many more patients worldwide and influence greatly their quality of life." With a European market launch for its first-generation device anticipated by mid-2026 following a CE Mark application, and a large-scale FDA trial on the horizon, the company is methodically laying the groundwork to bring its potentially transformative therapy to patients around the globe.