Berlin Heals Holding AG has successfully completed enrollment for the First-In-Human (FIH) CMIC-III study, which aims to evaluate a new Less Invasive approach to implanting its innovative cardiac microcurrent device. The company, headquartered in Zug, Switzerland, reported this milestone on October 10, 2025, noting that the topline data from the study is expected to be presented in 2026 at a major Cardiology Congress.
The CMIC-III study assesses the safety of this new implantation method, which is designed to increase accessibility for cardiologists and patients alike. With the completion of enrollment taking under six months since the first patient was implanted, the company is positioned to expand this treatment to a broader population. The CMIC device aims to address the significant unmet needs of patients suffering from Heart Failure, a condition that affects more than 64 million people globally.
John Brumfield, Chief Executive Officer of Berlin Heals, expressed gratitude to the patients, their families, and the trial investigators, stating, “This milestone reflects the degree of unmet need we are hearing from people living with Heart Failure.” He further emphasized the company’s commitment to sharing the Phase I results next year.
The CMIC therapy involves a fully implantable medical device consisting of two electrodes connected to an implantable generator that delivers a constant direct microcurrent to the heart. This treatment has shown promise in previous studies by reducing inflammation and promoting heart recovery. The previous generation of the device required a minimally invasive surgical procedure, while the new Less Invasive approach allows for implantation in an outpatient setting under conscious sedation.
As part of the FDA’s Breakthrough and TAP programs, Berlin Heals plans to initiate a pivotal FDA Investigational Device Exemption (IDE) trial, aiming for regulatory and reimbursement approvals for market launch. The potential for a less invasive option could significantly change the landscape of Heart Failure treatment, according to Stefan Anker, M.D., a Professor of Medicine at Charite, Berlin, and a senior author of the CMIC-II manuscript. He noted that if the results from the CMIC-III study mirror those seen in earlier trials, many more patients could benefit from this innovative therapy.
Heart Failure is a progressive condition characterized by the heart’s inability to meet the body’s demands for blood flow, leading to symptoms such as fatigue, shortness of breath, and palpitations. It represents a global health crisis, with a staggering annual cost of care amounting to $287 billion. In the western world, it is estimated that one in four people will develop Heart Failure in their lifetime, making it a leading cause of death, with mortality rates surpassing those of cancer.
Berlin Heals Holding AG has been at the forefront of developing treatments aimed at reversing Heart Failure. Following a successful First-In-Human study in 2019 and a Randomized Controlled Trial completed in 2024, the company is now focused on refining its approach to ensure a less invasive implantation process. With subsidiaries in Germany and the United States, Berlin Heals continues to innovate in the field of cardiac care, working towards solutions that enhance patient outcomes in a condition that currently has no commercially available cure.
