Johannes Mueller, MD, EMG, Ph.D. Co-founder and Chairman of Berlin Heals speaks about BERLIN HEALS Receives Breakthrough Device Designation from FDA for its C-MIC Heart Failure Device and Initiates Early Feasibility Study in the United States.
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BERLIN HEALS, a company designing new life-saving drugs for heart failure, revealed today that the US Food and Drug Administration (FDA) has given its patented Cardiac Microcurrent Therapy Device a Breakthrough Device Designation ("C-MIC"). The C-MIC is an implantable device that uses two electrodes to transmit a steady but low-current electrical DC current to the heart. The C-MIC technology has shown promise to become the first near-curative heart failure treatment, according to findings of first-in-human trials in 2019/20. Berlin Heals is about to file an Investigational Device Exemption (IDE) - Application with the FDA for an Early Feasibility Review (EFS) to begin later this year in the United States, after already launching a European-wide CE-study.
The FDA's Breakthrough Technologies initiative helps companies create medical devices that have the ability to cure or detect life-threatening or irreversibly disabling diseases. Heart failure, the most deadly condition on the planet, is a progressive inflammatory illness that affects millions of people worldwide. It accounts for 16% of all deaths and has seen the greatest growth among all deadly diseases since 2000, rising by more than 2 million to 8.9 million deaths in 2019. The FDA has designated the C-MIC technology as a revolutionary medicine because it has the potential to be the first medication to enable patients with cardiac failure to live a normal and mobile life.
As of today, no therapy, drug, or method has been developed and made available to reverse cardiac failure. Designation of the C-MIC as a breakthrough device by the FDA allows significant acceleration in the development and review of the technology, providing patients faster access. Marko Bagaric, CEO of Berlin Heals said, "Our completely novel therapeutic approach has the potential to almost cure heart failure rather than just delaying the progression of the disease. The FDA Breakthrough Designation is a tremendous turning point in the approval process for the US, enabling us to make our device available to patients with life-threatening heart disease much faster."
Berlin Heals has been designing cutting-edge technologies to cure heart disease since 2014. The patented C-MIC system was developed in response to the findings of pre-clinical trials conducted in close collaboration with the Medical University of Vienna, which verified that microcurrents have a highly beneficial effect on cardiac cells. The C-MIC is a small implantable device that causes cardiac muscle tissue to reverse remodel by supplying a steady but low-current electrical DC current to the heart. Extensive preclinical studies not only confirmed the effectiveness and protection of microcurrent application via C-MIC but also revealed a powerful anti-inflammatory impact as well as substantial improvements in cardiac function. Berlin Heals began the first implantations in patients under research conditions after verifying the distinctly beneficial effects of microcurrent in preclinical trials.
In April 2020, Berlin Heals successfully completed a pilot trial with ten patients. The electrical microcurrent was totally undetectable by the patients, had little effect on their heart rate, and resulted in dramatic changes in heart function in just a few days. The hearts of all of the patients, which are usually bloated in dilated cardiomyopathies, had narrowed, and all of the patients had dropped two NYHA classes. There were no device-specific side effects or follow-up procedures necessary.
With its C-MIC system, Berlin Heals has now initiated a European CE-multi-center analysis in Germany, Serbia, Austria, and Poland, which is scheduled to be completed by the end of 2022. In mid-2021, the organization will begin an Early Feasibility Study (EFS) in the United States with ten patients. The promising findings of the first human sample would then be confirmed in a significantly wider population of over 100 participants in a controlled two-arm multicenter experiment. The C-MIC technology will be available in Europe in 2022, the United States in 2025, and the rest of the world in 2025.