Berlin Heals secures funding to advance novel heart failure therapy and launch new clinical trial 

Berlin Heals Holding AG, winner of MedTech Malta 2024 Startup Pitch Competition, continues to push the boundaries of heart failure treatment with its innovative implantable therapy. The Swiss-based MedTech company is developing a groundbreaking solution designed to reverse remodel and aid recovery from heart failure, moving beyond symptom management to address the disease at its core.

Building on clinical success 

Following a successful First-In-Human study in 2019, Berlin Heals has since demonstrated sustained long-term results and completed a successful Randomised Controlled Trial in 2024. Building on this progress, the company is now advancing a less invasive implantation method that can be performed in an outpatient cardiac catheterisation lab. 

The device itself consists of two electrodes connected to an implantable generator, which delivers a constant direct microcurrent (DC) across the diseased heart. This steady flow of current reduces inflammation and reverses remodelling in the heart muscle. Studies have shown this mechanism can improve cardiac function and alleviate symptoms in patients living with heart failure. 

From innovation to next-stage trials 

After closing a successful A1 fundraising round earlier this year, Berlin Heals launched its latest clinical study, CMIC-III. This First-In-Man trial will implant 10 patients in an open-label evaluation, testing the less invasive approach that shortens recovery times and broadens access for clinicians and hospitals. 

The new A2 funding round will support completion of this study, as well as preparations for future double-blind studies and regulatory milestones, including an FDA Investigational Device Exemption submission.

“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, Berlin Heals Holding AG. “Over 10 years ago, we set off on a mission to reshape the heart failure market, and our early results put us on the path to make that vision a reality. This new funding round will help accelerate our development to bring this new treatment to the millions of heart failure patients around the world.” 

Marko Bagaric, Co-Founder and Member of the Board, Berlin Heals Holding AG, added: “It has been our vision from the beginning to not just mask the symptoms of this terrible disease, but actually reverse and remodel the heart back to a healthier state. The clinical results we have seen from our first studies have exceeded our original expectation. With this new approach of implanting in the outpatient cath lab and no longer requiring invasive surgery, we will be able to reach a much larger patient population.” 

Looking ahead 

Berlin Heals Holding AG was founded in 2014 and has since developed the C-MIC (Cardiac Microcurrent) system, the company’s flagship device. The therapy recently received Breakthrough Device Designation and has been selected for the FDA’s Total Product Life Cycle Advisory Program (TAP), highlighting its potential impact in addressing one of the most pressing challenges in cardiovascular medicine. 

CEO John Brumfield joined MedTech World Dubai 2025 earlier this year, and the company will also feature at MedTech Malta 2025, where Brumfield will present updates on Berlin Heals’ journey and clinical progress. 

Join us at MedTech Malta 2025 

Be part of the conversation on 12-14 November in Valletta, Malta, where Berlin Heals and other global innovators will share insights and breakthroughs in medical technology. For partnerships, speaking opportunities, or participation details, reach out to us at [email protected].