Further Studies to Confirm the Healing Effects of the C-MIC Technology

The results obtained in the First-in-human study involving 10 patients showed that the C-MIC device significantly improved cardiac performance by two levels of the New York Heart Association (NYHA) classification from Class III to I and that it furthermore improved the quality of life of patients with heart failure as assessed by the SF-36 questionnaire (published in ESC Heart Failure). Berlin Heals announced on March 4, 2021, the launch of a large-scale clinical evaluation with its C-MIC device to confirm the successful results obtained in the first-in-human study within a larger group of 100 patients.

Gaining Momentum After the Pandemic

The implementation of the clinical evaluation is gaining momentum after having been significantly slowed down by the Covid-19 pandemic (patient recruitment). Following the encouraging results from the first-in-human study, the commitment of the treating physicians was so strong that they were able to recruit further patients for the large scale clinical evaluation despite the difficult market environment. The Berlin Heals team is confident to be able to recruit the number of patients required by mid 2023. Finally, after the completion of the evaluation, the company intends to test the efficacy of its technology also with patients suffering from heart failure with preserved ejection fractions (HFpEF-patients).

As early as March 11, 2021, Berlin Heals was able to announce that the US Food and Drug Administration (FDA) granted a Breakthrough Device Designation for its proprietary Cardiac Microcurrent Therapy Device («C-MIC»).

Faster Access

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. As a consequence, the company decided to increase its activities in the US – in parallel to its European-wide CE marking – with the aim to formally file an Investigational Device Exemption (IDE) application with the FDA for an Early Feasibility Study (EFS). After initial preparations, Berlin Heals US, Inc., Delaware was incorporated in January 2022 as part of the group and to serve as a hub and domestic counterparty for all submissions to be made to the FDA.

Considerable Support

In the drafting process of the study protocol, Berlin Heals received considerable support from Mr. J. Eduardo Rame, M.D. (Philadelphia) and Mr. Daniel Goldstein, M.D. (New York), two renown and highly respected US cardiologists. After interested US clinics had been evaluated, the first draft of the study protocol could be completed and fine-tuned with the respective examination doctors who will participate in the study. The final text of the submission was then further refined and adapted and has been filed with the FDA in November 2022.