Berlin Heals CMIC-III Study Results

Berlin Heals Holding AG, a clinical-stage medical device company, announced positive results from its First-In-Human (FIH) CMIC-III study. The study evaluated a novel, less invasive approach to implanting its cardiac microcurrent (CMIC) device for heart failure treatment. Dr. Marat Fudim of Duke University presented the data at the Heart Rhythm Society's Annual Congress in Chicago. The results showed clinically significant improvements in LVEF, 6MWT, QOL, and NYHA with a strong safety profile, consistent with previous surgical implantation studies. This marks the first time the CMIC system was implanted via an outpatient procedure. Berlin Heals Holding AG has initiated Phase II of the CMIC-III study to evaluate the therapy in a broader heart failure population and will launch the C-MIC-IV double-blind sham-controlled trial. These studies aim to generate critical data to inform the design and de-risk the United States — Food and Drug Administration IDE pivotal trial for market approval.