German medtech company Berlin Heals Holding has raised more than $5m in its latest funding round aimed at advancing its treatment for heart failure.
The company is focused on developing a less invasive method for implanting its device, which has shown promise in reversing heart failure through a first-in-human study conducted in 2019 and a randomised controlled trial completed last year.
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Known as Cardiac Microcurrent (CMIC), the device consists of two electrodes linked to an implantable generator that delivers a continuous microcurrent to the affected heart.
This direct current is intended to reduce inflammation and facilitate the remodelling of the heart, leading to improved cardiac function and symptom relief, as evidenced by previous research, according to the company.
Berlin Heals Holding CEO John Brumfield said: 鈥淥ver ten years ago, we set off on a mission to reshape the heart failure market, and our early results put us on the path to make that vision a reality.
鈥淭his new funding round will help accelerate our development to bring this new treatment to the millions of heart failure patients around the world.鈥�
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By GlobalDataFollowing a successful A1 fundraising round earlier this year, Berlin Heals has progressed with the development of its less invasive implantation technique.
The company has initiated the CMIC-III trial, which will involve an open-label evaluation of ten patients.
This trial aims to demonstrate that the new implantation method allows for quicker recovery times and broader access to the therapy for clinicians and hospitals.
The newly secured A2 funding will be allocated towards completing the CMIC-III trial and preparing for future double-blind studies.
It will also be used for conducting additional testing and documentation necessary for a submission to the US Food and Drug Administration (FDA) for an investigational device exemption.
Berlin Heals board member and co-founder Marko Bagaric said: 鈥淚t has been our vision from the beginning to not just mask the symptoms of this terrible disease, but actually reverse and remodel the heart back to a healthier state. The clinical results we have seen from our first studies have exceeded our original expectations.鈥�
The C-MIC device is also currently under investigation for regulatory approval by CE authorities.
It has recently received a breakthrough device designation and has been selected for the Total Product Life Cycle Advisory Programme (TAP) by the FDA.
