ZUG, Switzerland, Sept. 1, 2025 -- Berlin Heals Holding AG, a MedTech company, is developing a novel treatment to reverse remodel and recover from Heart Failure. After a successful First-In-Human study in 2019 followed by sustaining long-term results and a successful Randomized Controlled Trial completed in 2024, the company has been developing a new approach to implant the device less invasively in an outpatient cardiac cath lab procedure.
The implant consists of two electrodes connected to an implantable generator that provides constant direct microcurrent across the diseased heart. This constant DC current reduces inflammation and reverse remodels the heart, which has been shown in previous studies to improve cardiac function and reduce symptoms.
After completing a successful A1 fundraising round earlier this year, the company was able to advance testing and development of this new approach and initiate a new First-In-Man study called the CMIC-III trial. This study will implant 10 patients in an open label evaluation where the leads are placed less invasively allowing for faster recovery and more clinicians and hospitals to access the therapy.
This new A2 funding round will support the completion of this study, preparation for future double blinding studies and further testing and documentation for an eventual FDA Investigational Device Exemption study 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 comments: "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."
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). The device is under investigation and will be evaluated by CE regulatory authorities for approval. Recently the C-MIC system received a Breakthrough Device Designation and was selected to be part of the Total Product Life Cycle Advisory Program (TAP) with the FDA.
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