Berlin Heals secured €10m ($10.72m) in funding for CE approval of C-MIC, an implantable electroceutical device.

The company plans to use the funding to ensure the financial means for CE approval and paving the way for US market entry.

The device is designed to propagate reverse remodelling of the cardiac muscle tissue by providing a constant but minimal electrical direct current that is equivalent to physiological electrical currents in the heart.

Developed for patients with dilated cardiomyopathy, the C-MIC device, a life-saving technology, utilises a constant electrical microcurrent to improve heart tissue inflammation and reduce edema.

This patented technology has demonstrated clinical improvements in heart failure patients.

Following the success of a pilot study involving ten patients, a further 35 C-MICs have been implanted in a randomised study.

With the recent funding, Berlin Heals is set to initiate studies in the US, with the Food and Drug Administration showing particular support for the device's potential.

Berlin Heals anticipates CE certification for the device by late 2025 or early 2026.

Patients from the initial pilot study have been monitored for three years, maintaining NYHA class 1 status, performing well in the six-minute walk test and reporting a high sense of well-being.  

To date, around €40m has been invested in developing the C-MIC technology, the implant itself and market approval processes.

Berlin Heals CEO Marko Bagaric said: “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.”