Berlin Heals Advances Less Invasive Approach for Heart Failure Treatment with New Funding Round

Berlin Heals Holding AG, a MedTech company based in Switzerland, is progressing the development of its implantable device designed to reverse remodeling and aid recovery in heart failure patients. The company’s technology, called C-MIC (Cardiac Microcurrent), delivers a constant direct current microcurrent across diseased heart tissue through two electrodes connected to an implantable generator. Prior studies have shown this approach reduces inflammation, improves cardiac function, and alleviates symptoms.

Following a First-In-Human study in 2019 and sustained long-term results, Berlin Heals Holding AG completed a randomized controlled trial in 2024. Building on this foundation, Berlin Heals Holding AG has developed a less invasive method to implant the device through an outpatient cardiac catheterization lab procedure. This approach aims to reduce recovery times and broaden access for clinicians and hospitals.

Earlier this year, Berlin Heals Holding AG closed a successful A1 fundraising round, enabling further testing and the initiation of the CMIC-III trial. This new First-In-Man study is designed to implant 10 patients in an open-label evaluation, using the less invasive implantation technique. According to the company, the results from this trial will inform subsequent clinical studies.

The newly launched A2 funding round will provide resources to complete the CMIC-III trial, prepare for future double-blind studies, and support documentation and testing for an eventual submission to the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption. Berlin Heals Holding AG views these steps as critical on the regulatory pathway in both Europe and the U.S.

“We are grateful for the continued and long-term support from our internal investors and welcome our new investors to the journey,” said John Brumfield, Chief Executive Officer of Berlin Heals Holding AG. He added that the mission began more than a decade ago with the goal of reshaping the heart failure market and that the new funding will accelerate development efforts to bring the treatment to patients worldwide.

Marko Bagaric, Co-Founder and Member of the Board, emphasized that the company’s goal has always been to move beyond symptom management and instead focus on reversing the disease process itself. He noted that early studies produced stronger-than-expected results and stated that the new outpatient implantation approach by Berlin Heals Holding AG could expand access to a larger patient population.

Founded in 2014, Berlin Heals Holding AG operates as a Swiss joint-stock company. Its C-MIC system remains under investigation and subject to evaluation by CE regulatory authorities. The device has recently received Breakthrough Device Designation and has been selected to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP).

---

Additional Content Added

Later in 2025, Berlin Heals Holding AG published the results of its C-MIC II trial, enrolling 70 ambulatory patients with non-ischaemic dilated cardiomyopathy. Data showed that patients receiving C-MIC therapy plus standard medical treatment had significantly greater improvements in left ventricular ejection fraction (LVEF), functional class, exercise capacity, and quality of life compared to controls. Cardiovascular News+2implantable-device.com+2

Also, two-year outcomes of the first-in-human pilot study from Berlin Heals Holding AG revealed sustained improvements in LVEF, walk-distance, and symptoms, even after deactivation of the device. No device-related adverse events occurred over that period. Newswire+1

With the less invasive implant route under evaluation, Berlin Heals Holding AG is aiming to reduce hospital time, lower risk, and make C-MIC implantation feasible in more settings, including smaller hospitals. The company is also monitoring durability of benefit, cost-effectiveness, and longer-term safety as larger trials begin.

Marko Bagaric, Co-Founder and Member of the Board, emphasized that the company’s goal has always been to move beyond symptom management and instead focus on reversing the disease process itself. He noted that early studies produced stronger-than-expected results and stated that the new outpatient implantation approach by Berlin Heals Holding AG could expand access to a larger patient population.