ZUG, Switzerland, Feb. 18, 2025 /PRNewswire/ -- Berlin Heals Holding AG, a late stage MedTech start up, has developed a breakthrough method and a product for the therapy of heart failure. The product - an electronic device called C-MIC - has already successfully been tested in patients in a pilot study and recently completed enrollment in an International Multi-Center Controlled Randomized Clinical Trial for CE certification. The company will present the new data at upcoming conferences and publish the results soon. With the therapeutic method now well supported, the company is ready to test the next generation technology in less invasive implant approaches.
To reach these next milestones, the company has successfully raised over CHF 7Million from investors in a recently executed financing round. This funding will support First-In-Human studies to evaluate the safety and efficacy of these new approaches to prepare for the large pivotal trial for global regulatory and reimbursement approvals. This funding will also support further development of the product and preparation for CE submission for the first-generation device.
Berlin Heals Holding AG has already demonstrated the unprecedented success of its dilated cardiomyopathy therapy in a first-in-human pilot study. The company recently presented the Long-Term sustainable results of that study in a Late Breaking Clinical Trial session at the Technology and Heart Failure Therapeutics (THT) conference on February 11th in Boston and has plans to publish the results in an upcoming journal.
John Brumfield, Chief Executive Officer, Berlin Heals Holding AG comments:
"We are very grateful to our internal investors that continue to support our mission to heal Heart Failure. We are also excited to welcome our new investors that have joined us on this journey. The results from our early clinical work showed strong potential for this new therapeutic approach. We are excited to share the results of our new Randomized Clinical Trial later this year. This funding round will give us the opportunity to test the method through several new less invasive approaches to determine which technique should be used in our Pivotal Trial for FDA and global market entry.
Dr. Felix Baader, Chairman of the Board, Berlin Heals Holding AG comments:
"I had the pleasure of meeting several patients together with Co-Founder Marko Bagaric from our first two studies and can see the real impact our innovation has had on returning significant quality of life to them. They were so grateful to have their lives back and be active again. With this funding round, we further our progress to impact many more lives ahead."
Berlin Heals Holding AG is a Swiss joint-stock company founded in 2014. The company has developed a revolutionary implantable device called "C-MIC" (Cardiac Microcurrent), which - by way of a constant electrical microcurrent and the ensuing electrical field - results in a sustainable and swift improvement of outcomes in heart failure patients according to recent studies.
John Brumfield
media@berlinheals.de
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