Berlin Heals Holding AG BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure Device and Initiates Early Feasibility Study in the United States BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure Device and Initiates Early Feasibility Study in the United States BERLIN and ZUG, Switzerland, March 11, 2021 (GLOBE NEWSWIRE) -- BERLIN HEALS, a company developing novel life-saving treatments for heart failure, announced today that the US Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for its proprietary Cardiac Microcurrent Therapy Device ("C-MIC"). The C-MIC is an implantable device that delivers a constant but minimal electrical DC-current to the heart via two electrodes. Based on results of first-in-human studies in 2019/20, the C-MIC device has shown potential to become the first near-curative heart failure therapy. Berlin Heals, which has already launched a European-wide CE-study, is now about to file an Investigational Device Exemption (IDE) - Application with the FDA for an Early Feasibility Study (EFS) to commence in the US later this year.