HeartBeam Inc. (NASDAQ: BEAT)

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

The company’s mission is to empower both patients and physicians with actionable cardiac data wherever 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 which could reduce time to treatment, improve outcomes, and lower costs across the healthcare continuum.

HeartBeam’s system aims to bring clinical-grade cardiac assessment into the home. HeartBeam is preparing for commercial launch as its 12-lead ECG synthesis software undergoes regulatory review, building on prior clearance of its 3D ECG system for arrhythmia assessment. The company plans to leverage its unique longitudinal ECG dataset and deep learning algorithms to advance predictive capabilities in the future.

HeartBeam is headquartered in Santa Clara, California.

Products

HeartBeam’s flagship innovation is its credit card-sized, cable-free ECG device that collects heart signals in three non-coplanar dimensions and synthesizes a 12-lead ECG. Cleared by the FDA in December 2024 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 pending 12-lead ECG synthesis software, developed from the same 3D signal acquisition, successfully met clinical endpoints in the VALID-ECG study and is currently under FDA review for arrhythmia assessment. This software combined with an on-demand cardiologist reader service is expected to form the backbone of HeartBeam’s commercial launch strategy, providing patients with access to a synthesized 12-lead ECG outside of the traditional hospital setting and enabling physician interpretation of patient ECGs from anywhere.

From the core, the team is building an ecosystem that includes integration with wearables, automated arrhythmia assessments, AI-driven wellness features, community features and trending insights. The ecosystem is intended to drive adoption and increase the overall value of the HeartBeam System.

Artificial Intelligence and Predictive Analytics

To enhance its diagnostic capabilities, HeartBeam is developing AI-powered arrhythmia detection algorithms to be validated in collaboration with Mount Sinai Heart. In early testing, these deep learning algorithms achieved diagnostic accuracy comparable to standard 12-lead ECGs when classifying atrial fibrillation, atrial flutter, and sinus rhythm.

Additionally, HeartBeam’s AI engine has the potential to transform routine monitoring into predictive power in the future. The company’s platform enables frequent readings, building a unique longitudinal ECG dataset unique that no one else offers. By leveraging deep learning on the repeated measurements, there is an opportunity to develop predictive capabilities, such as screening for hidden cardiac conditions and forecasting risk of future events. The unique longitudinal dataset will create a defensible data moat as the company continues to advance its AI program.

Market Opportunity

HeartBeam is targeting a large unmet need in cardiac care by delivering hospital-grade ECG diagnostics to patients outside of traditional healthcare settings. Cardiovascular disease is the leading cause of death worldwide, yet most cardiac events occur at home, where standard 12-lead ECGs are not available, leading to costly delays in diagnosis and treatment. HeartBeam’s FDA-cleared 3D ECG technology is designed to close this critical gap with on-demand, remote diagnostic capabilities.

The company’s initial commercialization strategy focuses on two distinct U.S. entry markets. The first includes approximately 500,000 elevated-risk patients in concierge care settings, representing a $250 million to $500 million annual revenue opportunity. The second addresses a larger direct-pay segment of 2.6 million elevated-risk individuals, with potential revenues of $1.3 billion to $2.6 billion annually. Future expansion may include reimbursement-driven pathways through Medicare Advantage, providers, and payer partnerships.

HeartBeam anticipates annual subscription pricing between $500 and $1,000 per patient, with roughly 50% gross margins on device costs and 70%+ on recurring revenue. Based on a model using five U.S. regions, each with an estimated 75,000 eligible patients, HeartBeam projects that just 10% adoption would generate approximately $20 million in gross profit—enough to reach cash flow break-even under current pricing and margin assumptions. Over time, the company’s longitudinal ECG dataset and predictive AI capabilities are expected to deliver additional value to healthcare systems, research institutions, and life science partners.

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 and Chief Technology Officer, is a semiconductor and medtech innovator who previously led product design teams at Intel and founded NewCardio. He holds over 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 over 175 studies and 650 publications. He has founded over 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.