Company Research Report: Berlin Heals Holding Ltd.
Company Overview
Name
Berlin Heals Holding Ltd.
Mission of the Company
To develop its proprietary C-MIC technology and establish a novel therapeutic approach to not only delay the progression of heart failure disease but to virtually cure it.
Founding
Founded in 2014.
Founders
Co-Founders:
- Dr. Johannes Hartwig Müller, M.D., M.Sc.
- Dr. Peter Göttel, M.D., M.Eng.
Key People
- Dr. Felix Baader, Chairman of the Board
- Marko Bagaric, Co-Founder and Member of the Board
- Dr. Johannes Hartwig Müller, M.D., M.Sc., Co-Founder of Berlin Heals GmbH
- Dr. Peter Göttel, M.D., M.Eng., Co-Founder of Berlin Heals GmbH
- John Brumfield, CEO of Berlin Heals Group
- Dr. Nazmi Krasniqi, Member of the Board
- Roland Diggelmann, Member of the Board
Headquarters
Zug, Switzerland
Berlin Heals operates an R&D subsidiary in Berlin, Germany.
Number of Employees
No information is available.
Revenue
No information is available.
Known For
Berlin Heals is known for its innovative, life-saving, implantable electroceutical device, the C-MIC, which addresses heart failure by using electrical microcurrents.
Products
Product Offered: C-MIC Device
Description
The C-MIC device is a revolutionary, novel cardiac implant developed as a near-curative treatment for patients with systematic and refractory heart failure. It is a small implantable device that supports reverse remodeling of cardiac muscle tissue by delivering a constant but minimal electrical direct current (DC).
Key Features
- Propagation of reverse remodeling of the cardiac muscle tissue.
- Delivery of minimal electrical direct current equivalent to physiological currents in the heart.
- Improvements in heart function, size, and quality of life have been rapidly noticed post device placement.
- The device includes two electrodes which are placed on the epicardium of the left ventricle and in the right ventricular cavity.
Recent Developments
New Products and Features
- The C-MIC device has been the focus of recent development, with ongoing clinical studies to validate its effectiveness.
New Studies and Partnerships
- A pilot study with promising results was completed, showing improvements in heart function and quality of life.
- Commencement of a European-wide CE study in 2021 and a parallel Early Feasibility Study in the US.
- Granted Breakthrough Device Designation by the FDA, which accelerates the development process and patient access in the US.
- In 2022, Berlin Heals US, Inc. was incorporated in Delaware to manage submissions to the FDA.
- Significant clinical support has been received from renowned US cardiologists.
Notable Press Releases
- March 11, 2021: Received Breakthrough Device Designation from the US FDA.
- March 4, 2021: Launched a pivotal CE Mark Study after positive first-in-human studies results.
- Continuing momentum and further study evaluations in Europe and the US to confirm the device’s efficacy.
Conclusion
Berlin Heals Holding Ltd. stands as a pioneeing entity in heart failure treatment through its innovative C-MIC device, significantly impacting patients' lives through advanced medical technology.
