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 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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