HeartBeam Inc. (NASDAQ: BEAT)

HeartBeam Inc. (NASDAQ: BEAT) is a medical technology company pioneering a new approach to cardiac care by delivering clinical-grade electrocardiogram (ECG) insights outside traditional clinical settings. Its proprietary platform supports a scalable app-based solution for rhythm monitoring.

The company’s mission is to empower both patients and physicians with actionable cardiac data wherever arrhythmia symptoms begin, addressing a critical gap in the first hours of cardiac events. Through its connected cardiac care ecosystem, HeartBeam is establishing a new model for remote monitoring that deepens patient engagement and delivers more actionable insights for physicians. This approach is designed to obtain early diagnosis of arrhythmias which could reduce time to treatment, improve outcomes, and lower costs across the healthcare continuum.

HeartBeam has entered its initial commercialization phase following U.S. Food and Drug Administration (“FDA”) 510(k) clearance of its 12-lead ECG synthesis software for arrhythmia assessment in December 2025, building on prior clearance of its 3D ECG system for arrhythmia assessment. The company is executing a focused initial market release targeting concierge and preventive cardiology practices to validate real-world performance and support broader commercialization.

HeartBeam is headquartered in Santa Clara, California.

Products: FDA-Cleared Credit-Card Sized Device and a 12-Lead ECG Patch in Development

HeartBeam’s flagship innovation is its FDA-cleared, credit card-sized, cable-free ECG device that collects heart signals in three non-coplanar dimensions and synthesizes a 12-lead ECG for arrhythmia assessment. The HeartBeam System enables patients to capture high-fidelity heart data during symptomatic episodes, even outside a clinical environment.

The company’s FDA-cleared 12-lead ECG synthesis software builds on the same 3D signal acquisition and successfully met clinical endpoints in the VALID-ECG study. This software, combined with an on-demand cardiologist reader service enabled through a partnership with HeartNexus, forms the backbone of HeartBeam’s commercial offering, providing patients with access to a synthesized 12-lead ECG for arrhythmia assessment outside of the traditional hospital setting and enabling physician interpretation from virtually anywhere.

From this core platform, the company plans to build an ecosystem where new features will be added, such as integration with wearables, automated arrhythmia assessments, AI-driven wellness features, community functionality and trending insights. As part of its commercialization efforts, HeartBeam has entered into an initial commercial agreement with ClearCardio, a preventive cardiology practice, supporting a staged rollout within a highly engaged patient population and providing a model for expansion into similar care networks.

In addition to the FDA-cleared device, the company recently unveiled a second form factor – a working prototype of an on-demand 12-lead ECG patch. The company believes this 12-lead ECG patch has the ability to disrupt the ambulatory cardiac monitoring market, a rapidly growing $2 billion revenue market with existing reimbursement.

The on-demand 12-Lead patch functions just like existing patches, continually recording the patient’s heart rhythms with a single lead. But using HeartBeam’s patented core technology, a patient simply places two fingers on the front of the device to record an ECG signal and synthesize a 12-Lead ECG upon symptom onset or when prompted by the HeartBeam app. This has the potential to bring better diagnostic capabilities to the patch segment in the future. The device will integrate into existing workflows and will leverage the existing reimbursement for patch systems. Market research indicates that this will be a best-in-class patch.

Heart Attack Detection

One of the major problems in cardiology is that there is no good way for patients who experience chest pain to know if they are having a heart attack. Patients wait an average of 3 to 4 hours before seeking care, and every 30 minutes of delay increases the risk of death by 7.5%. The 12-lead ECG is the standard for heart attack detection, but traditional 12-lead ECGs have 10 wired electrodes that need to be placed by a technician and are not applicable for home use.

This is a major problem, with 20 million people in the US at risk of a heart attack, including 8 million who have had a previous heart attack. HeartBeam’s technology has the potential to address this major need and the company has multiple proof of concept studies showing that the HeartBeam System is similar to a standard 12-Lead ECG for assessing potential heart attacks.

To advance these efforts, the company recently commenced the ALIGN-ACS study, a European pilot study comparing the HeartBeam ECG to a standard 12L ECG in detecting heart attacks. The study is expected to complete by the end of the 3rd quarter 2026, and the study will inform the design of an FDA pivotal study and future marketing application for an ischemia indication expansion.

Artificial Intelligence and Predictive Analytics

To enhance its cardiac monitoring capabilities, HeartBeam is advancing AI-powered cardiac analysis through both internal development and a strategic collaboration with the Icahn School of Medicine at Mount Sinai. This effort is focused on building and validating next-generation AI-ECG algorithms using HeartBeam’s proprietary longitudinal dataset.

Additionally, HeartBeam’s AI engine has the potential to transform routine monitoring into predictive capability over time. The company’s platform enables frequent readings, building a unique longitudinal ECG dataset that supports the development of more personalized and predictive cardiac insights. By leveraging deep learning on repeated measurements, there is an opportunity to develop screening tools for hidden cardiac conditions and forecast risk of future events, further expanding the platform’s clinical and commercial relevance.

Market Opportunity

HeartBeam is targeting a large unmet need in cardiac care by delivering clinical-grade ECG capabilities to patients outside of traditional healthcare settings. Cardiovascular disease remains the leading cause of death worldwide, yet most cardiac events occur at home, where standard 12-lead ECGs are not available, leading to delays in diagnosis and treatment.

HeartBeam’s cardiac platform has the opportunity to address more than 50 million patients in the U.S. alone, representing a total addressable market of over $40 billion.

The company’s initial commercialization strategy is focused on the structured direct-pay healthcare segments, including concierge and preventive cardiology practices and a target market of over 5 million patients. This is a market segment where patient engagement is high and adoption of innovative technologies can occur more rapidly. These settings provide an efficient pathway to validate clinical utility, pricing and workflow integration before broader expansion.

As the company expands its cleared indications to heart attack assessment, that will expand the addressable market to over 20 million patients at risk of a heart attack in the U.S.

Over time, expansion into reimbursement-driven channels and the development of AI-enabled predictive capabilities may further extend the company’s addressable market.

Leadership Team

Robert Eno, Chief Executive Officer and Director, brings over 30 years of experience in the medical technology industry, including leadership roles at HeartFlow, OptiMedica and NeoGuide Systems. He joined HeartBeam as President in January 2023 and was appointed CEO in October 2024, later joining the board in May 2025 to support commercial growth.

Branislav Vajdic, Ph.D., Founder, President and Director, is a semiconductor and medtech innovator who previously led product design teams at Intel and founded NewCardio. He holds more than 20 patents and is the original architect of HeartBeam’s core technology.

Tim Cruickshank, Chief Financial Officer, oversees financial strategy and capital allocation. He works closely with the leadership team to support commercialization while maintaining financial discipline aligned with key regulatory milestones.

Peter Fitzgerald, M.D., Ph.D., Chief Medical Advisor, is Director of the Center for Cardiovascular Technology at Stanford and a seasoned clinical trialist with more than 175 studies and 650 publications. He has founded more than 20 medtech companies and advises the FDA on digital health analytics.

Ken Persen, Chief Technology Officer, has more than 28 years of experience in cardiac rhythm management and digital health. He previously served as CTO and CEO at LIVMOR and held engineering roles at Cameron Health and Guidant.

Bryan Humbarger, Chief Commercial Officer, joined the company in January 2026 and brings more than 25 years of experience commercializing cardiovascular and digital health technologies. He previously held leadership roles at Proprio, HeartFlow, AliveCor and Eko Health, and is responsible for leading HeartBeam’s commercialization strategy and execution.