ZUG, Switzerland — October 10, 2025 — Leads & Copy — Berlin Heals Holding AG has completed enrollment in its First-In-Human (FIH) CMIC-III study, which evaluates the safety of a new Less Invasive approach to implanting the CMIC device. Topline data are expected in 2026 and will be submitted for presentation at a major Cardiology Congress.
The company is focused on revolutionizing heart failure care with a first-of-its-kind durable treatment. The new Less Invasive approach aims to expand treatment to a wider patient population, building on evidence from the first-generation surgical approach. The company intends to pursue a pivotal FDA IDE trial through the FDA Breakthrough and TAP programs, targeting regulatory and reimbursement approvals for market launch.
According to Berlin Heals Holding CEO John Brumfield, completing enrollment in under 6 months marks a pivotal moment for the company. Stefan Anker, M.D., Professor of Medicine at Charite, Berlin, noted the promise of Microcurrent therapy based on prior trials and the potential benefit of a less invasive implant approach for more patients.
Cardiac Microcurrent (CMIC) Therapy uses a fully implantable device to deliver constant direct microcurrent across the heart, reducing inflammation and remodeling the heart. The new Less Invasive approach allows for implantation in a cardiac catheterization lab as an outpatient procedure.
Heart Failure affects over 64 million people globally, with high costs and mortality rates. Berlin Heals Holding is developing a novel treatment to reverse remodel and recover from Heart Failure, building on successful prior studies.
Contact: John Brumfield, Chief Executive Officer, Berlin Heals Holding AG
Source: Berlin Heals Holding AG
