BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
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
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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.
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BERLIN and ZUG, Switzerland, March 04, 2021 (GLOBE NEWSWIRE) BERLIN HEALS, a company dedicated to developing and offering novel and life-saving treatments for patients suffering from heart failure, announces results of a first-in-human study published in
ESC Heart Failure, in patients with dilated cardiomyopathy for its proprietary C-MIC device. The C-MIC is a small implantable device that delivers a minimal constant electrical DC current to the heart. The results show significant, rapid improvements in heart function, heart size and quality of life of patients. Thus, this treatment has the potential to become the first sustainable, almost curative, treatment for heart failure in patients with unmet medical needs.