- Completed Enrollment in First-In-Human Phase I study of Less Invasive Approach
- Expected to Present 6-Month data in 2026 at a major Cardiology Congress
- Via Less Invasive Approach, more Cardiologists could implant out-patient
- Additional studies expanding indications and level of evidence are planned next
Berlin Heals Holding AG, a leading clinical-stage medical device company focused on revolutionizing the care of Heart Failure with a first of its kind durable treatment, today announced it has completed enrollment in the First-In-Human (FIH) CMIC-III study to evaluate 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. Berlin Heals is on track to expand this new Less Invasive approach to a wider population of patients and build on the body of evidence already seen in the first-generation surgical approach. As part of the FDA Breakthrough and TAP programs, we intend to pursue a pivotal FDA IDE trial that will lead to regulatory and reimbursement approvals for market launch.
“Completing enrollment in under 6 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,” said Berlin Heals Holding Chief Executive Officer John Brumfield. “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.”
“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.”
