#Switzerland #Heart Failure #Zug #Berlin Heals #CMIC Therapy

Berlin Heals Holding AG Reaches a Key Milestone in Heart Failure Treatment

Berlin Heals Holding AG, a pioneering company in the medical device sector, has made headlines with its recent announcement regarding the completion of patient enrollment in the Phase I CMIC-III study. This innovative research is centered around a less invasive method for treating heart failure, a condition that affects millions of individuals worldwide.

The CMIC-III study seeks to assess the safety and effectiveness of the newly developed Cardiac Microcurrent (CMIC) Therapy, which utilizes a fully implantable medical device designed to deliver a constant microcurrent to the heart. This approach is anticipated to be significantly less invasive than traditional surgical methods, which should simplify the implantation process, ultimately increasing access for a broader patient population.

In a statement, Berlin Heals Holding AG's Chief Executive Officer, John Brumfield, expressed his enthusiasm, noting, "Completing enrollment in under six months since our first patient's procedure is a pivotal moment for our company and for patients suffering from heart failure. We commend the patients, their families, and our dedicated trial investigators for their support. We eagerly await the topline results from the Phase I study next year."

The data gleaned from this study will be essential for determining future regulatory pathways and expanding the clinical indications for this promising therapy. The topline results are expected to be shared in 2026 at a major cardiology congress, where the medical community will get an insight into the findings of this cutting-edge approach.

The Need for Effective Heart Failure Solutions

Heart failure is an increasingly prevalent condition, with over 64 million people affected globally, and nearly 1 in 4 individuals in parts of the western world expected to develop it in their lifetime. Symptoms such as fatigue, shortness of breath, and palpitations greatly diminish the quality of life for sufferers. Additionally, heart failure leads to frequent hospitalizations and imposes a heavy economic burden, with annual costs surpassing $287 billion in the United States alone.

Despite various treatment options, current therapies often fall short in providing adequate relief to patients, highlighting the urgent need for innovative solutions like the CMIC Therapy. By delivering targeted microcurrent stimulation to the heart, this treatment addresses the underlying causes of heart failure, reducing inflammation and improving overall cardiac function.

About CMIC Therapy

CMIC Therapy is groundbreaking in its ability to reverse the damage caused by heart failure. The device—comprised of two electrodes connected to an implantable generator—works through constant direct microcurrent, an advancement over previous generations requiring more invasive techniques. The new less invasive methodology allows for implantation in a cardiac catheterization lab, further enhancing its accessibility for outpatient procedures.

The previous studies, including the CMIC-I First-In-Human study and CMIC-II Randomized Controlled Trial, demonstrated the efficacy of microcurrent therapy, paving the way for its introduction in less invasive forms. Renowned experts in the field, such as Dr. Stefan Anker of Charite Berlin, commend the promise of CMIC Therapy to revolutionize treatment options for heart failure patients.

Future Plans

As Berlin Heals Holding AG looks forward to sharing results from the CMIC-III study, they also express their intention to commence pivotal FDA IDE trials that will facilitate regulatory approval and market launch of the CMIC device. This ambitious project signifies a broader strategy to address various heart failure care challenges and expand the therapeutic indications for the innovative technology.

Berlin Heals Holding AG's commitment to transforming heart failure treatment through technological innovation stands to affect countless lives worldwide, demonstrating the vital importance of collaboration within the medical community to push boundaries and create hope for patients in need.