Swiss-German medtech start-up secures CHF 6 million to advance heart therapy

Founded in 2014 as a Swiss joint-stock company by renowned heart specialists and engineers, Berlin Heals Holding AG has developed an easily implantable low-invasive microcurrent implantable device called “C-MIC” (Cardiac Microcurrent). The device propagates reverse remodelling of the cardiac muscle tissue by delivering a constant but minimal electrical direct current equivalent to physiological electrical currents in the heart. This results in a sustainable and swift improvement of the texture of heart tissue of heart failure patients.

Berlin Heals completed a pilot study (dual center First-in-human studies in Belgrade, Serbia and Vienna Austria) with 10 patients suffering from ‘dilative cardiomyopathy’ in April 2020. So far, over 35 C-MIC devices have been implanted to date, with positive clinical effects - the results showed significant, rapid improvements in heart function, heart size and quality of life of patients. Based on these results, Berlin Heals launched a European-wide CE Study in 2022 while preparing an Early Feasibility Study in the US. The company has already recruited roughly 60% of the required CE patients, and the data generated for CE certification study appears to confirm the initial findings.

The Zug-based startup has obtained fresh capital amounting to CHF 6 million to further accelerate the CE certification study. The company expects that 100% of the patients required for the CE certification study will be fully recruited by Q1 of 2024, with respective study results available approximately six months later. The company aims to obtain the CE marking for the C-MIC device thereafter. So far, roughly CHF 35 million have been invested in research, development, and regulatory procedures.

“We have initiated the financing round to complete the CE-certification study swiftly and successful”, said Marko Bagaric, Chief Executive Officer, Berlin Heals Holding AG. “We are convinced that Berlin Heals Holding AG’s groundbreaking technology will have a significant impact on heart insufficiency, which remains widespread and a leading cause of death worldwide.”

The round attracted new investors, including the Swiss company Fumedica, a special provider in heart surgery and invasive cardiology, as a new investor. According to the company, Fumedica could play an essential role in the initial distribution of the C-MIC in the DACH region.

(Press release/RAN)