Under the direction of CEO John Brumfield, Berlin Heals is on a mission to revolutionize the treatment of heart failure with its breakthrough Cardiac Microcurrent Therapy Device, C-MIC, offering vital new hope for patients battling chronic heart conditions.
Berlin Heals was founded out of a desire to address one of the most significant unmet needs in cardiology: heart failure. Brumfield brings over two decades of experience in Medtech innovation and extensive knowledge of the heart failure space, making him uniquely suited to lead this initiative.
Brumfield shared, “I’ve worked on innovative heart failure technologies throughout my career, from the CardioMEMS project to building out St. Jude’s heart failure division, which later became part of Abbott.”
Founded in 2014 by two thoracic surgeons with deep backgrounds in cardiac care, Berlin Heals originated from a simple yet powerful idea: Could electrical currents heal the heart? Through years of lab research, bench testing, and animal studies, the team discovered that small electrical currents could not only reduce inflammation in heart cells but potentially reverse heart failure altogether. Brumfield emphasized, “What excites me about this technology is it has the potential to move people from a Stage C or D back to a Stage B, reversing the path of the disease.”
Heart failure is a global epidemic, affecting nearly 57 million people worldwide, with treatments today focusing primarily on managing symptoms rather than addressing the underlying cause. Brumfield explained, “It’s a debilitating disease, and treatment today is either medications, which are getting a lot better, or device-based therapies. Cardiac resynchronization therapy (CRT) is a great therapy, but it only addresses a small sliver of the heart failure population.”
The heart failure market is experiencing a wave of innovation, with advanced management tools like CardioMEMS and newer therapies like cardiac contractility modulation and baroreflex stimulation. Brumfield elaborated, “There’s a ton of innovation in this space because the market need is so huge. But when I look at these new therapies, they focus on the symptoms—and when you turn off these therapies, the symptoms come back.”
Berlin Heals is developing C-MIC, a small implantable device that propagates reverse remodeling of the cardiac muscle tissue by delivering a constant but minimal electrical direct current equivalent to physiological microcurrents. The C-MIC transmits the electrical currents through two leads: one positioned on the epicardium of the left ventricle and the other within the right ventricular cavity. “By putting these cells through a microcurrent, the body can change how it operates, allowing the cells to go into a recovery mode,” he explained.
Brumfield emphasized the uniqueness of Berlin Heals’ solution: “It’s very different than the other therapies on the market, which focus on pacing and stimulation, whether a nerve or a muscle. What we’re doing is creating a healing environment for the tissue.”
One of the most notable aspects of the company’s technology is the potential for sustained benefit, even after the device is turned off. Brumfield shared, “We have two years of data showing that patients maintain their benefit. That's something you don’t see in other therapies—you don’t see that kind of sustained benefit.”
Berlin Heals has made remarkable strides in its mission to revolutionize heart failure treatment. The company recently completed its CE trial and expects to secure approval by the end of 2025. Brumfield said, “The Data Safety and Monitoring Board recommended we end our CE trial early because we’d already hit our endpoint, and it was unethical to continue enrolling. It shocked me how strong the evidence was looking.”
The company has raised significant capital and recently secured approximately $10.7 million in funding for the CE approval of C-MIC. “We’ve already raised $45 million to get us through the next phase,” Brumfield said, “but as we move toward commercialization and scaling, we’ll be raising more funding.”
Simultaneously, the company is developing its second-generation device. Brumfield shared, “We hope to enter the U.S. market with the second generation device, which would not be an open surgery but a less invasive approach.”
According to LSI’s Market Analysis and Projections database, the market for implantable devices (e.g., implantable cardioverter defibrillators [ICDs] and cardiac resynchronization therapy [CRT] devices) to manage heart failure is estimated to reach $7.2B in 2024. The market is extremely mature, with growth in market size projected at 2.5% from 2023 to 2028. These devices are largely used to manage symptoms (e.g., reduced left ventricular ejection fraction) and prevent sudden cardiac death.
Of the implantable devices available for managing heart failure, CRT devices that incorporate pacing and defibrillation capabilities (CRT-Ds) are preferred. This is because many patients with heart failure also present with arrhythmia, which increases their risk of sudden cardiac arrest.
Existing implantable solutions play an important role in improving patient quality of life and survival. However, unmet needs abound with current technologies. Among the many unmet needs of heart failure patients, the greatest may be that existing technologies only manage the symptoms and do not treat (i.e., halt or reverse) disease progression.
Brumfield has been selected to present at LSI USA ‘25 next March 17-21 in front of hundreds of global medical technology companies. Join us in welcoming Brumfield to the event in Dana Point, CA, where he will share the latest updates on Berlin Heals’ technology and development.
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