Berlin Heals Holding AG has completed enrollment in the first-in-human (FIH) study to evaluate the safety of a less invasive approach to implanting its cardiac microcurrent (CMIC) device.

Topline data are expected in 2026 and will be presented at a major Cardiology Congress. Berlin Heals is on track to expand this new less invasive approach to a wider population of patients and build on the evidence already collected in the first-generation surgical approach. As part of the U.S. Food and Drug Administration (FDA) Breakthrough and TAP programs, the company will pursue a pivotal FDA IDE trial to obtain the necessary regulatory and reimbursement approvals for market launch.

“Completing enrollment in under six months since implanting our first patient marks a pivotal moment for the company and reflects the degree of unmet need we are hearing from people living with heart failure,” Berlin Heals Holding CEO John Brumfield said. “We are very grateful to the patients, their families and the trial investigators for their enthusiasm and look forward to sharing topline results from the Phase I study next year.”

Cardiac microcurrent (CMIC) therapy is delivered through a fully implantable medical device that consists of two electrodes connected to an implantable generator that provides constant direct microcurrent across the diseased heart. This constant DC current reduces inflammation and reverse remodels the heart that has been shown in previous studies to improve cardiac function and reduce symptoms. The first generation required a minimally invasive surgical procedure where a cardiothoracic surgeon placed an electrode on the outside of the heart. The new less invasive approach can be implanted in a cardiac catheterization lab through a conscious sedation out-patient procedure by a cardiologist.

“Based on results from the CMIC-I FIH and CMIC-II Randomized Controlled Trial (RCT), microcurrent therapy showed great promise to positively transform the treatment for heart failure,” said Stefan Anker, M.D., professor of Medicine at Charite, Berlin, and senior author of the CMIC-II manuscript. “If similar results can be shown in a less invasive implant approach, many more patients could benefit from this new therapy.”

Heart failure is a condition where the heart is weakened and cannot meet the body’s demand for blood flow. Symptoms include shortness of breath, fatigue, and palpitations, which limit the ability to perform daily activities. The progressive disease leads to frequent hospital admissions, poor clinical outcomes, and high care costs. Heart failure affects more than 64 million people globally and costs healthcare systems $287 billion annually. In the western world, one in four people will develop the disease in their lifetime. The disease—for which there currently is no cure—is a leading cause of death with a worse mortality than cancer.

Berlin Heals Holding is developing a novel treatment to reverse remodel and recover from heart failure. After a successful first-in-human study in 2019 followed by sustaining long-term results and a successful randomized controlled trial completed last year, the company has been developing a new approach to implant the device less invasively in an outpatient cardiac catheterization lab procedure. The company is based in Zug, Switzerland, with subsidiaries in Germany and the United States.