#Chicago #Switzerland #Heart Failure #Berlin Heals #CMIC

Positive Developments in Heart Failure Treatment

Berlin Heals Holding AG, a clinical-stage medical device company, has recently made headlines by presenting positive results from its CMIC-III First-In-Human (FIH) study aimed at treating heart failure (HF). This is an important advancement in the medical field as it focuses on a first-in-class, durable therapy designed to transform the treatment of heart failure.

The significant findings of the study were revealed during a High Impact Science session at the Heart Rhythm Society Annual Congress held in Chicago, Illinois. Dr. Marat Fudim, Associate Professor of Cardiology and HF at Duke University, presented the results, marking the first instance of the CMIC system being implanted through an outpatient procedure, signifying a major shift in how heart failure is treated.

Noteworthy Findings

The data showcased clinically substantial improvements in various parameters, notably the Left Ventricular Ejection Fraction (LVEF), the Six-Minute Walk Test (6MWT), Quality of Life (QoL), and the New York Heart Association (NYHA) classification. What is more impressive is the study's strong safety profile, a crucial factor when considering new medical interventions. The findings also echoed the positive outcomes seen in previous studies that employed a more invasive surgical implantation approach.

To date, 52 patients have undergone this procedure across three separate studies, highlighting not only the potential widespread applicability of the CMIC device but also its non-invasive nature that encourages a greater number of patients to seek treatment.

Professor William T. Abraham, M.D., a prominent figure in the study, expressed optimism, stating, "Earlier heart failure studies of microcurrent therapy demonstrated compelling clinical benefits but required a surgical implantation approach. These new data from the CMIC-III study show that we can achieve comparable improvements using a less invasive, outpatient procedure, significantly enhancing the safety profile and expanding access to a much broader population of patients."

Looking Ahead

Berlin Heals has already initiated the next phase of this exciting research. Phase II of the CMIC-III less invasive FIH study will explore the therapy's effects on patients with mildly reduced LVEF (greater than 40% and less than 50%). This move is expected to widen the applicability of the therapy to an even broader spectrum of heart failure patients.

In conjunction with this phase, the company plans to kick off the C-MIC-IV double-blind sham-controlled trial. This trial will focus on enrolling patients suffering from both non-ischemic and ischemic heart failure, specifically those with LVEF between 20% to 40%, primarily at centers located in Western Europe. The combined aim of these two studies is to engage approximately 122 patients into the treatment regimen, generating invaluable data that will be essential in designing a pivotal trial for FDA market approval.

About Berlin Heals

Founded in 2014, Berlin Heals Holding AG is a Swiss joint-stock company dedicated to innovating treatment options for those suffering from heart failure. At the core of its technological advancements lies the C-MIC technology, which transmits a consistent electrical microcurrent to the heart, creating a localized electrical field designed to enhance cardiac function. Based on prior clinical studies, this unique approach has displayed the potential to yield rapid and sustained benefits in patients wrestling with heart failure.

In conclusion, the results from the CMIC-III study herald a hopeful future for heart failure treatment, showcasing the profound impact of less invasive procedures and expanding the reach of effective medical care. By continuing to innovate and meticulously study these therapies, Berlin Heals is setting the stage for a new era in the treatment of this significant health concern.