Berlin Heals Holding AG has successfully completed enrollment in the Phase I CMIC-III study, focusing on a new less invasive approach for treating heart failure. This first-in-human study aims to assess the safety of implanting the Cardiac Microcurrent (CMIC) device, with topline results anticipated in 2026. The findings are expected to be presented at a major cardiology congress, marking a significant milestone in the company’s efforts to revolutionize heart failure treatment.
The CMIC-III study, which enrolled patients within six months of initiating the trial, represents a response to the pressing needs of individuals living with heart failure. John Brumfield, Chief Executive Officer of Berlin Heals, expressed gratitude to the trial participants and investigators, emphasizing the excitement surrounding the study’s developments. “Completing enrollment in under six months marks a pivotal moment for the company and reflects the degree of unmet need we are hearing from people living with heart failure,” Brumfield stated.
This less invasive approach aims to extend treatment options to a broader demographic, building on the evidence gathered from prior studies, including the CMIC-I and CMIC-II trials. According to Stefan Anker, M.D., a Professor of Medicine at Charite in Berlin and senior author of the CMIC-II manuscript, microcurrent therapy has shown promise in transforming heart failure treatment. “If similar results can be shown in a less invasive implant approach, many more patients could benefit from this new therapy,” Anker noted.
Understanding CMIC Therapy and Heart Failure Challenges
Cardiac Microcurrent (CMIC) Therapy involves a fully implantable device that applies direct microcurrent to the heart, aiming to reduce inflammation and reverse the remodeling process in damaged cardiac tissue. The initial generation of this device required a surgical procedure performed by cardiothoracic surgeons. In contrast, the new less invasive method allows cardiologists to perform the implantation in an outpatient setting, using conscious sedation in a cardiac catheterization lab.
Heart failure is a debilitating condition affecting over 64 million people worldwide. It occurs when the heart cannot adequately pump blood to meet the body’s needs, resulting in symptoms like shortness of breath, fatigue, and palpitations. The disease is a global crisis, with one in four individuals in the western world expected to develop heart failure during their lifetime. The financial impact of managing heart failure is staggering, with an annual cost of approximately $287 billion, underscoring the urgent need for effective treatments.
Future Plans for Berlin Heals
Berlin Heals is positioned to undertake a pivotal FDA Investigational Device Exemption (IDE) trial, which will facilitate regulatory and reimbursement approvals for market launch. The company’s commitment to innovating heart failure treatments is evident in its strategic plans to expand the indications and levels of evidence for the CMIC device.
With the completion of the CMIC-III study enrollment, Berlin Heals Holding AG is set to make significant strides in advancing the treatment landscape for heart failure. The anticipated topline results in 2026 could pave the way for broader acceptance of less invasive heart therapies, potentially transforming the lives of millions affected by this chronic condition. As the company continues to navigate this critical phase of development, it remains focused on delivering breakthrough solutions that meet the pressing needs of patients around the globe.
