Funding secured to advance clinical programme for implantable heart failure device

Berlin Heals has announced the successful closing of a new financing round, raising over US$10 million to advance the company’s cardiac microcurrent technology and expand its clinical research programme.

The company has developed a novel therapeutic approach for the treatment of heart failure based on its proprietary implantable device, C-MIC (Cardiac Microcurrent), a novel implantable system that delivers low-intensity microcurrent to failing myocardium.

The system has demonstrated promising clinical outcomes in the C-MIC II trial, where patients were randomised to receive C-MIC therapy plus guideline-directed medical therapy (GDMT) or GDMT alone, and assessed against a primary endpoint of the difference in change in left ventricular ejection fraction (LVEF) at six months. The company is seeking to expand on the evidence, with updated clinical data expected this year.

The next phase of innovation will focus on less invasive implantation techniques and enhanced device designs intended to broaden patient eligibility and streamline future adoption, the company says in a press release. The newly secured capital will support expanding indications into wider patient populations and begin larger double blinded trials to prepare for the US Food and Drug Administration (FDA) investigational device exemption (IDE) submission.

Berlin Heals has previously demonstrated sustained functional and quality-of-life improvements in patients with dilated cardiomyopathy treated with C-MIC. Long-term follow-up data from early studies continue to support the durability of the therapy, reinforcing confidence in the company’s clinical and regulatory strategy.

“Closing this financing round marks an important milestone for us,” John Brumfield, chief executive officer of Berlin Heals Holding comments. “We are deeply thankful to our Co-Founder of Berlin Heals Holding Ltd and the Member of the Board—Marko Bagaric for achieving another impressive round of financing. His long-term vision and dedication to this company is crucial for the trust of our long-standing shareholders and welcoming new investors who share our vision. 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 commercialisation.”

“Heart failure remains an area of tremendous unmet medical need. 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.”

Berlin Heals Holding AG is a Swiss joint-stock company founded in 2014. The company’s C-MIC technology delivers a constant electrical microcurrent to the heart, generating a localised electrical field designed to improve cardiac function. Based on clinical studies to date, this approach has shown the potential to deliver rapid and sustained benefits for patients suffering from heart failure.


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