Further Studies to Confirm the Healing Effects of the C-MIC Technology
In order to confirm the positive results generated in the first-in-human study within a significantly larger group of cardiomyopathy/heart failure patients, Berlin Heals decided in the spring of 2021 to launch a pivotal study to confirm the efficacy of its C-MIC device.
Europe: CE Marking
Clinical Evaluation of C-MIC Device to Confirm Initial Successful Results
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).
USA: Early Feasibility Study (FDA)
Breakthrough Device Designation granted by US Food and Drug Administration (FDA)
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»).
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.
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.
Promising Results in
Dual Center first-in-human Studies (2019/2020) & Launch of EU and US Studies (2023: Berlin Heals) successfully completed a pilot study (dual center first-in-human studies in Belgrade, Serbia and Vienna, Austria) with 10 patients in April 2020.
Rapid improvements in heart function, heart size and quality of life of C-MIC placement patients within days of C-MIC placement.
Patients’ average 6-minute walking distance improved by almost 100% after 4 weeks.
Hearts, which were typically enlarged in dilated cardiomyopathies, shrunk in size.
All patients saw their NYHA classification drop by two classes. The NYHA classification is a scheme originally published by the New York Heart Association to classify heart disease according to severity
The electrical microcurrent remained completely undetectable to the patients and did not interfere with the heart rhythm.
No device-specific side medication or follow-up procedures were required.
Berlin Heals is currently undertaking a European-wide CE Study and is in parallel preparing an Early Feasibility Study in the US.
The patients maintained and increased these improvements for 6 months after implantation.