ZUG,
Switzerland, June 17,
2024 /CNW/ -- 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 Cures 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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SOURCE Berlin Heals Holding AG