#Switzerland #Heart Failure #Zug #Berlin Heals #C-MIC

Berlin Heals Holding AG Advances Heart Failure Treatment

Berlin Heals Holding AG, a cutting-edge MedTech company based in Switzerland, has announced a significant funding milestone, raising over $5 million to propel the development of revolutionary treatments for heart failure. The financial backing will support innovative research and expedite the introduction of less invasive procedures aimed at reversing heart conditions.

Since its inception in 2014, Berlin Heals has focused on redefining the approach to heart failure management. Recent studies have showcased promising outcomes from their C-MIC (Cardiac Microcurrent) device, which aims to remodel the heart through a unique method of microcurrent stimulation. This device consists of two electrodes connected to an implantable generator that delivers a continuous DC current to the heart, reducing inflammation and regenerating its functionality.

The journey began with a successful first-in-human trial in 2019, followed by a series of long-term assessments, culminating in a successful randomized controlled trial completed in 2024. These studies demonstrated not only the safety of the C-MIC technology but also its effectiveness in improving patients' symptoms and overall heart function.

Building on these achievements, the company launched an A1 fundraising round earlier this year, which allowed them to advance their testing and development efforts. The latest A2 funding round will fund the initiation of a groundbreaking clinical trial known as the CMIC-III trial. This trial, which will begin soon, will focus on implanting the C-MIC device in an outpatient setting, ensuring a less invasive approach that promises faster recovery times for patients.

"We are immensely grateful for the ongoing support of our investors and are excited to welcome new partners on this journey," remarked John Brumfield, CEO of Berlin Heals Holding AG. "Our goal over the past decade has been to transform the landscape of heart failure treatment, and this latest funding will accelerate our mission to make these advanced therapies available to millions of patients worldwide."

Mr. Brumfield emphasized the company’s ambition to not merely mask symptoms but facilitate genuine recovery from heart conditions. With the potential to reach a larger patient population, the less invasive implantation technique could fundamentally change how heart failure is treated globally.

Co-founder Marko Bagaric echoed this sentiment, highlighting how the clinical outcomes obtained thus far have surpassed their initial expectations. The implications of such a treatment are vast, not only for patients but for the healthcare system as a whole, enabling more efficient and accessible therapeutic options.

Berlin Heals Holding AG, with its innovative spirit and commitment to healthcare advancement, remains at the forefront of tackling a pressing health issue that affects millions globally. With the promising advancements stemming from their C-MIC device and the ongoing support from the medical community and investors, the future looks bright for heart failure treatment. As they prepare for the upcoming double-blinded studies and potential FDA Investigational Device Exemption applications, the company's pioneering efforts may signal a new era in cardiac healthcare.

In addition, the C-MIC device has received a Breakthrough Device Designation from the FDA, indicating its potential to address a critical need in the medical field. Participation in the Total Product Life Cycle Advisory Program (TAP) further exemplifies the commitment to quality and compliance in bringing this transformative technology to market.

As Berlin Heals continues its journey, their determined efforts represent a beacon of hope for heart failure patients, embodying the very spirit of innovation in medical technology. The coming years may see a significant shift in the standards of care for heart failure, and with it, a renewed promise of healthier lives for countless individuals.