HeartBeam Conducts Strategic Shift to Accelerate Adoption of its Ambulatory ECG Signal Platform

HeartBeam Inc. is conducting a reorganization to prioritize global market reach and capital efficiency while accelerating execution. The company has aligned its operations around focused implementation teams led by Founder/President Branislav Vajdic, Ph.D., and Executive Chairman Rich Ferrari, and those teams will aim to give every at-risk cardiac patient access to HeartBeam’s technology.

The reorganized structure streamlines decision-making, improves accountability, and enables leadership to concentrate resources on achieving key milestones while maintaining disciplined management. The reorganization is expected to sharpen the company’s focus on delivering results and create a meaningfully lower-cost structure. As part of these changes, former CEO Robert Eno will transition to a consulting role.

“Our mission is to drive widespread global adoption of our technology,” Ferrari said. “We thank Rob for bringing HeartBeam to this point, from securing FDA clearances to establishing the commercial foundation that makes this next phase possible. Now, we are streamlining our operations and broadening our reach so that this potentially life-changing system can get into the hands of as many patients as possible, as quickly as possible.”

The reorganization will enable the company to focus on the key deliverables which separate it from the crowded cardiac monitoring space, namely:

• An AI-ready signal, built for more than cardiac care. Artificial intelligence (AI) can only deliver actionable insight based on the quality of the signal it is given. HeartBeam has built what it believes is the best ambulatory ECG signal-acquisition platform—a data-rich 3D signal that is the input AI needs to move from inference to true detection. This broader platform strategy has been made possible most recently by AI’s rapid advance: The company can now extract accurate, clinical-grade recordings directly from its 3D signal-acquisition and ECG processing platform—turning more than a decade of signal science into an immediately actionable foundation. Moreover, the company believes this same signal quality can serve third-party AI platforms being developed across medicine that depend on high-quality, real-world ECG data.
• Advancing toward heart attack detection. A central focus of this strategy is expanding HeartBeam’s platform beyond arrhythmia assessment into reliable heart attack detection, which the company believes is one of the largest unmet needs in cardiac care. The company continues to build the evidence base needed to pursue this expanded indication and believes this milestone will make its device a must-have for every cardiac patient, with the potential to save millions of lives and billions of dollars in avoidable medical costs.
• One platform, every market. HeartBeam hopes to achieve global adoption by partnering its patented 3D ECG platform across the five channels that already have distribution—governments and national health systems, ECG OEMs, Holter and patch manufacturers, health systems and integrated delivery networks, and consumer wearable companies—and by adapting its technology to the form factor each use case requires. The company believes its technology can be adapted to multiple form factors: a ruggedized unit that lets a rural health clinic triage a patient in minutes, an adhesive patch for longer-term monitoring, a simpler form factor for an older or less agile patient, or a sleek, compact card an expert user slips into a wallet.

The company received U.S Food and Drug Administration (FDA) marketing clearance for its synthesized 12-lead ECG signal for arrhythmia assessment in December 2025, giving physicians a familiar format they trust. The company believes this unique capability will be critical to adoption in many use cases.

“HeartBeam’s technology addresses a fundamental gap in cardiac care: the ability to get a verified, clinical-grade ECG reading anywhere, at any time, without a clinic visit. With commercialization underway, the company is positioned to make that capability routine for the millions of Americans living with or at risk for arrhythmia,” Dr. Vajdic stated. “At the same time, we will continue to conduct the previously announced clinical studies to accelerate the development of our offering into a comprehensive detection platform for heart attack and other cardiac conditions beyond arrhythmia.”

HeartBeam Inc. is a medical technology company aiming to transform the detection and monitoring of critical cardiac conditions. The company has developed the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is located to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care—all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.¹ The company holds more than 20 issued patents related to technology enablement.

Reference
¹ Cleared Indications for Use. The HeartBeam System with 12-Lead ECG synthesis software is FDA cleared for arrhythmia assessment only. The heart attack detection indication and algorithm are not FDA cleared and not available in the US or any other geography at this time. Refer to the Company’s Cleared Indications for Use at https://www.heartbeam.com/indications for details on the intended use of its technology.