Berlin Heals Holding AG Secures CHF 6 Million in New Funding to Advance CE Certification of Breakthrough Heart Failure Device C-MIC

Berlin Heals Holding AG Successfully Completes New Round of Financing for Ongoing CE Certification Research

Zug, SwitzerlandJune 29, 2023PR Newswire -- Berlin Heals Holding AG, a medical technology start-up, has developed a groundbreaking method and product for the treatment of heart failure. The product, an electronic device named C-MIC, has been successfully tested on patients in a pilot study and is currently undergoing the CE certification process. In this context, the company has successfully raised an additional CHF 6 million from investors in a recently completed financing round. As a result, significant progress has been made in advancing the CE process and preparing for FDA regulatory studies (to approve its patented technology for treating dilated cardiomyopathy).

With approximately 60% of the required CE patients already recruited, the company has secured this funding. In its first-in-human pilot study, Berlin Heals Holding AG has demonstrated unprecedented success with its dilated cardiomyopathy therapy. The current CE certification study, which began in 2022, has generated data that clearly confirms the preliminary results. To date, around 35 million Swiss francs have been invested in research and development as well as regulatory procedures. Berlin Heals Holding AG anticipates that 100% of the patients required for the CE certification study will be fully recruited by the end of the first quarter of 2024, with corresponding study results expected to be published approximately six months later. The company aims to obtain the CE mark for the C-MIC device as soon as possible thereafter.

Berlin Heals Holding AGChiefExecutiveMarko BagaricCommented: 

"We initiated this round of financing to quickly and successfully complete the CE certification study. I am particularly pleased that we have been able to win the favor of a specialized supplier in the field of cardiac surgery and interventional cardiology, the new investor Fumedica from Switzerland. In fact, Fumedica can play a significant role in the initial distribution of the product in the DACH region. We believe that Berlin Heals Holding AG's breakthrough technology will have a major impact, as heart failure remains a widespread condition globally and is one of the leading causes of death."

Berlin Heals Holding AG is a Swiss joint-stock company founded in 2014 by renowned cardiologists and engineers. This startup has developed a revolutionary implantable device named "C-MIC" (Cardiac Microcurrent), which continuously and rapidly improves the cardiac tissue quality of heart failure patients through constant microcurrents and the resulting electric field. To date, more than 35 C-MIC devices have been successfully implanted, achieving very positive outcomes.

Contact:
Marko Bagaric
info@berlinheals.com