ZUG, Switzerland, June 29, 2023 /PRNewswire/ — Berlin Heals Holding AG, a MedTech startup, has developed a breakthrough method and a product for the therapy of heart failure. The product – an electronic device called C-MIC – has already successfully been tested in patients in a pilot study and is currently undergoing CE certification procedures. In this context, the company has successfully raised another CHF 6 million from investors in a recently executed financing round. Consequently, the advancement of the CE procedures and the preparations for the FDA regulated studies for the approval of its patented technology for the therapy of dilated cardiomyopathy have made massive progress.
This funding comes at a point when the company has already recruited roughly 60% of the required CE-patients. Berlin Heals Holding AG has already demonstrated the unprecedented success of its dilated cardiomyopathy therapy in a first-in-human pilot study. The data generated so far for the current CE certification study which commenced in 2022 appears to clearly confirm the initial findings. To date, roughly CHF 35 million have been invested in research & development and for regulatory procedures. Berlin Heals Holding AG expects that 100% of the patients required for the CE certification study will be fully recruited by Q1 of 2024 with respective study results available approximately six months later. The company aims to obtain the CE marking for the C-MIC device soon thereafter.
Marko Bagaric, Chief Executive Officer, Berlin Heals Holding AG comments:
"We have initiated the financing round with the objective to complete the CE-certification study swiftly and successfully. I am particularly delighted that we could win the Swiss company Fumedica, a special provider in heart surgery and invasive cardiology, as a new investor. Fumedica, in fact, could play an important role in the initial distribution of the product in the DACH region. We are convinced that Berlin Heals Holding AG’s groundbreaking technology will have a significant impact, for heart insufficiency which remains widespread and a leading cause of death worldwide."
Berlin Heals Holding AG is a Swiss joint-stock company founded in 2014 by renowned heart specialists and engineers. The start-up has developed a revolutionary implantable device called "C-MIC" (Cardiac Microcurrent), which – by way of a constant electrical microcurrent and the ensuing electrical field – results in a sustainable and swift improvement of the texture of heart tissue of heart failure patients. To date over 35 C-MIC devices have been implanted with very good results.