Berlin Heals’ innovative implantable C-MIC device has demonstrated encouraging clinical results in the treatment of heart failure. They are now published in ESC Heart Failure. The C-MIC is a small implantable device that delivers a minimal constant electrical microcurrent to the heart. The pilot study confirmed the feasibility and safety of the treatment, and indicated significant improvements in heart function, heart size, and quality of life of patients. Thus, this treatment may have the potential to become an option in the treatment for heart failure.
When patients suffer from heart failure, the heart can no longer pump a sufficient amount of blood to supply all organs with the necessary level of oxygen. Despite recent advances, heart failure is still the world’s most lethal disease, accounting for 16% of all deaths globally.
SCIRENT, a full-service contract research organization specialized in early phase cardiovascular trials, conducted the first-in-human pilot study for the C-MIC device. SCIRENT worked with selected sites that are particularly well-suited for this early phase pilot trial due to their specialization and experience. With engaged investigators at the sites and highly qualified SCIRENT staff, the enrollment target was reached within time, delivering high-quality data.
“We were very pleased to see that our patients, who previously could barely walk 200 meters during the 6-minute walk test, were now able to walk more than 400 meters only two weeks after the C-MIC device had been implanted – almost reaching the level of healthy patients,” says Marko Bagaric, CEO of Berlin Heals.
CE mark study launched to confirm results
Berlin Heals has now launched a CE mark study with the C-MIC device to confirm the successful results obtained in the first-in-human study within a larger group of patients. SCIRENT will again coordinate the trial and support the sponsor in their efforts to find better therapies for heart failure in the future. “Our mission is to help medical device, pharma, and biotech companies to develop innovative medical drugs and devices for patients with cardiovascular diseases,” states Hans-Dirk Düngen, CEO of SCIRENT.
About BERLIN HEALS
Berlin Heals Holding AG was founded in 2014 as an innovative life science company with the mission to develop its proprietary C-MIC technology to treat heart failure. The C-MIC device is a novel cardiac implant using constant microcurrent to treat heart failure and meanwhile has turned out to represent a breakthrough near-curative treatment for patients with systematic and refractory heart failure. After completing the CE-study, the company intends to test the efficacy of its technology with patients suffering from heart failure with preserved ejection fractions (HFpEF-patients).
SCIRENT was founded in 2012 with the vision to help clients develop innovative medical drugs and devices for patients with cardiovascular diseases. Our dedicated team of experienced clinical and regulatory professionals can provide faster and more efficient service from our trial sites in Europe and North America.