Funding secured for CE approval of the groundbreaking C-MIC device from Berlin Heals Holding AG

ZUG, Switzerland, June 17, 2024 /PRNewswire/ -- The Berlin Heals Holding AG has developed the C-MIC device, a revolutionary and life-saving treatment for patients with heart failure (DCM / dilated cardiomyopathy). The patented technology is easily implantable and has shown unprecedented clinical improvements in patients with heart failure. With the help of a constant electrical microcurrent, the inflammatory parameters of the patient's heart tissue are sustainably improved and edema (excess water) is flushed out of the heart.

To date, 35 C-MICs have been successfully implanted in a randomized study. The excellent data from a previous pilot study with 10 patients has now been confirmed. Accordingly, the company was able to raise a further CHF 10 million from new and existing investors in a recent financing round. This means that CE approval is financially secured and the next steps for US approval can be initiated. These funds will also be used to initiate the first studies in the USA.

In the meantime, Berlin Heals Holding AG has been able to follow up with patients from the pilot study for 3 years. All patients are still in NYHA class 1, achieve around 400 meters in the 6-minute walk test (6MGT) and, most importantly, the patients report a very good sense of well-being. To date, around CHF 40 million has been invested in the development of the technology, the C-MIC implant and market approval. Berlin Heals Holding AG expects CE certification at the end of 2025 / early 2026. Due to the great success for patients, approval of the C-MIC implant in the USA is being particularly encouraged by the FDA, which confirms that Berlin Heals is developing a game changer in the treatment of heart failure.

Marko Bagaric, Chief Executive Officer of Berlin Heals Holding AG comments as follows:
"We are convinced that we have developed a product for the treatment of severe heart failure that will restore quality of life to many patients worldwide and significantly extend their life expectancy. I am convinced that C-MIC will set a new standard in the treatment of these patients in the future. After a short operation, an imperceptible, constant microcurrent flows, which ensures that patients feel very well again within a few weeks."

Berlin Heals Holding AG is a private Swiss stock corporation founded in 2014 with subsidiaries in Germany and the USA.

C-MIC is a novel cardiac implant that provides a breakthrough treatment for patients with heart failure. The C-MIC is a small implantable device that delivers a constant but minimal electrical direct current (DC) to the heart, resulting in a rapid and sustained improvement in cardiac performance. To date, the C-MIC has been successfully implanted in around 50 patients.

Contact:
Marko Bagaric
info@berlinheals.com

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