Monday, June 17, 2024
Berlin Heals Holding AG has developed the C-MIC device, a groundbreaking treatment for heart failure, particularly dilated cardiomyopathy (DCM).
This patented, easily implantable technology has demonstrated significant clinical improvements in heart failure patients by delivering a constant electrical microcurrent.
This microcurrent effectively reduces inflammation in heart tissue and helps eliminate excess water (edema) from the heart.
So far, 35 C-MIC devices have been successfully implanted in a randomized study, corroborating the promising results from a previous pilot study with 10 patients.
The positive outcomes have enabled Berlin Heals to secure an additional CHF 10 million from new and existing investors. This funding will ensure the financial support needed for CE approval and initiate the first studies in the USA as part of the steps toward US approval.
The company has followed up with patients from the pilot study for three years, and all patients remain in NYHA class 1.
They achieve approximately 400 meters in the 6-minute walk test (6MWT) and report a high quality of life. To date, around CHF 40 million has been invested in the development of the technology, the C-MIC implant, and its market approval.
Berlin Heals expects to receive CE certification by late 2025 or early 2026. The FDA is particularly encouraging the approval of the C-MIC implant in the USA, recognizing its potential as a revolutionary treatment for heart failure.
"They are confident that we have developed a product that will restore quality of life and significantly extend life expectancy for many heart failure patients worldwide.
They believe the C-MIC will set a new standard in treating these patients. Following a brief procedure, an imperceptible, constant microcurrent flows, leading to a substantial improvement in patient well-being within weeks."
Source: prnewswire.com
