Berlin Heals Advances Less-Invasive Heart Failure Therapy With Positive CMIC-III Data

New updates have been reported about Berlin Heals Holding AG.

Berlin Heals Holding AG has reported encouraging first-in-human results for its less invasive implantation approach to the C-MIC cardiac microcurrent device, positioning the company to broaden its addressable heart failure market and advance toward pivotal trials. The CMIC-III study, presented in a High Impact Science Session at the Heart Rhythm Society Congress in Chicago, showed that outpatient implantation of the C-MIC system delivered meaningful gains in left ventricular ejection fraction, six-minute walk distance, quality of life, and New York Heart Association class, with a strong safety profile comparable to earlier, more invasive pericardial surgical implants.

The Swiss clinical-stage company is now moving into Phase II of the CMIC-III program, targeting patients with mildly reduced ejection fraction (LVEF above 40% and below 50%), while simultaneously launching the C-MIC-IV double-blind, sham-controlled trial in Western Europe for both ischemic and non-ischemic heart failure with LVEF between 20% and 40%. Across these studies, Berlin Heals expects to increase its total implanted patient experience from 52 to roughly 122, generating data intended to significantly de-risk the design and regulatory path for an FDA IDE pivotal trial. If successful, the company’s constant microcurrent therapy, which creates a localized electrical field to restore cardiac function, could represent a differentiated, durable treatment option that is deliverable in an outpatient setting, with strategic implications for reimbursement, procedure adoption, and partnering opportunities in the heart failure device market.