HeartBeam Inc

1/14/2026

Invention:	Cable-free portable ECG
Name:	HeartBeam^™
FDA Approval:	Yes (arrhythmia only)
Pathway:	Class II 510(k)
Patents (US):	14
NASDAQ:	BEAT

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INTRODUCTION

HeartBeam, a US-based medical technology company, has developed a compact, cable-free ECG device—roughly the size of a credit card. It connects via Bluetooth to a smartphone app to capture a 30-second recording of the heart’s electrical activity, which is then reviewed by an on-call cardiologist. Unlike a standard 12-lead ECG—the front-line diagnostic for heart attack—HeartBeam is practical outside the clinical setting, where multiple electrodes and professional setup make traditional devices cumbersome.

HeartBeam’s pivotal trial, VALID-ECG, demonstrated substantial equivalence between the system’s synthesized 12-lead ECG and a standard 12-lead ECG for arrhythmia assessment, supporting FDA clearance for this indication. The company plans to conduct a subsequent pivotal trial to seek an indication for ischemia detection. If successful, HeartBeam™ would be the only portable ECG solution capable of detecting ischemia, enabling identification of the onset of myocardial infarction outside the clinical setting.

THE INVENTION

The HeartBeam™ device uses integrated electrodes to capture the heart’s electrical signals in three non-coplanar dimensions, recording the full electrical activity of the heart. Personalized algorithms convert these signals into a physician-ready 12-lead ECG in real time. This vectorcardiographic (VECG) approach provides the same diagnostic information as a standard ECG in a compact, cable-free form factor. The device is controlled via a smartphone app over a Bluetooth connection, and the resulting report is sent to an on-call cardiologist for clinical interpretation and patient triage.

HeartBeam also includes a web-based physician portal that displays diagnostic suggestions, patient history and symptoms, the synthesized 12-lead ECG, and the underlying three recorded leads, allowing clinicians to compare current data with a patient’s baseline ECG.

CLINICAL STUDIES

Arrythmia assessment

HeartBeam’s pivotal clinical study, VALID-ECG, was designed to validate the clinical equivalence of the company’s synthesized 12-lead ECG to a conventional standard 12-lead ECG for arrhythmia assessment. The study addressed a core clinical limitation of traditional ECG systems: the impracticality of acquiring a full 12-lead ECG outside a healthcare setting due to equipment and personnel requirements. By enabling patients to self-record a three-lead, non-coplanar ECG that is algorithmically synthesized into a 12-lead ECG, HeartBeam aimed to demonstrate that physician-grade ECG interpretation could be performed reliably outside the clinic.

The study enrolled 198 patients across five U.S. hospitals and arrhythmia clinics, with 127 paired recordings ultimately included in the primary analysis. Each patient underwent simultaneous 30-second ECG recordings using both a standard 12-lead ECG (administered by a healthcare professional) and the HeartBeam device (self-recorded by the patient under supervision). A panel of three independent, board-certified electrophysiologists, blinded to recording modality, evaluated the ECGs for rhythm diagnosis and performed quantitative measurements of ECG intervals and amplitudes.

For qualitative rhythm diagnosis, the synthesized 12-lead ECG demonstrated 93.4% overall diagnostic agreement with the standard 12-lead ECG (115 of 123 analyzable cases). Agreement was 96.2% for normal sinus rhythm and 88.6% for arrhythmic rhythms, including atrial fibrillation, premature atrial contractions, premature ventricular contractions, and bradyarrhythmias. These results indicate that cardiologists reviewing the synthesized ECG reached the same rhythm conclusions as they did with conventional ECGs in the vast majority of cases.

Quantitative analysis further supported equivalence between the two modalities. Measurements of key ECG intervals (RR, PR, QRS, QT) and waveform amplitudes showed small mean differences, narrow confidence intervals, and high Pearson correlation coefficients (often exceeding 0.9), indicating close agreement between synthesized and standard ECG waveforms. Together, these findings demonstrated that the HeartBeam system can generate ECG waveforms of sufficient fidelity for manual physician interpretation in arrhythmia assessment.

Overall, the VALID-ECG study established that HeartBeam’s cable-free, portable system can reliably synthesize a clinically interpretable 12-lead ECG for arrhythmia evaluation outside the clinical setting. This evidence supported FDA clearance for arrhythmia assessment and provides the technical and clinical foundation for future studies aimed at expanding indications, including ischemia detection.

Heart attack detection

Coronary Occlusion Detection Study

HeartBeam’s foundational clinical study, “Coronary Artery Occlusion Detection Using 3‑Lead ECG System Suitable for Credit Card‑Size Personal Device Integration,” evaluated the ability of the company’s vectorcardiographic (VECG) approach to detect coronary artery occlusion—the physiological cause of myocardial ischemia and most heart attacks—using a simplified three‑lead configuration suitable for a portable device.

The study enrolled 66 patients undergoing percutaneous coronary intervention (PCI) and recorded both VECG and standard 12‑lead ECGs before and during a 90‑second balloon occlusion of a coronary artery, simulating an acute coronary event. Automated computer analysis of ST‑segment shifts from both signal types showed that, when compared against a patient’s baseline recording, VECG had an AUC of 0.95—nearly identical to the standard 12‑lead ECG methods (AUCs 0.96 and 0.97), indicating similar diagnostic performance in identifying occlusion. Spot (single recording) measurements performed less well (AUC 0.72 for VECG and 0.68–0.77 for 12‑lead), underscoring the value of a baseline comparison in improving accuracy.

The study also highlighted the limitations of human interpretation: cardiologist readings of standard 12‑lead ECGs exhibited notable intra‑ and inter‑observer variability that did not occur with automated analysis. The inclusion of a patient’s “normal baseline” dramatically improved diagnostic performance and reliability, suggesting that HeartBeam’s VECG approach—especially with baseline comparison—can match or potentially exceed traditional interpretation under some conditions. These findings support the feasibility of a portable, patient‑initiated ECG system for early ischemia detection, a key step toward reducing symptom‑to‑balloon time in acute coronary syndromes.

ALIGN-ACS Pilot Study

HeartBeam’s ALIGN-ACS pilot study is designed to evaluate the ability of the HeartBeam System to detect acute coronary syndromes in real-world emergency department patients presenting with chest pain.

The study plans to enrol 100 patients presenting to the emergency room with chest pain. Each patient will undergo evaluation with both a standard 12-lead ECG and the HeartBeam device, with results from each method compared against the patient’s final clinical diagnosis at discharge. This design allows investigators to assess how accurately HeartBeam’s three-lead, three-dimensional ECG configuration identifies heart attacks relative to the clinical gold standard used in hospital care.

The study builds on earlier proof-of-concept research showing that a 3D ECG configuration similar to HeartBeam’s system can detect myocardial ischemia with accuracy comparable to a conventional 12-lead ECG. By testing the technology in symptomatic emergency department patients, the ALIGN-ACS study moves beyond controlled occlusion models toward validating performance in a real-world clinical population.

Data from the pilot study will inform the design of a future multi-center pivotal trial, which would support a regulatory submission to expand the HeartBeam System’s indications beyond arrhythmia assessment to include heart attack detection.

COMPETITIVE LANDSCAPE

Current ECG systems used outside of the clinical setting fall into two categories: consumer wearable devices focused on heart rhythm monitoring, and prescription-based systems designed to provide diagnostic information related to ischemic events.

Consumer wearables for AFib detection

This segment consists of FDA-cleared ECG devices sold directly to consumers without a prescription. These products are typically single-lead ECG systems designed to detect heart rhythm abnormalities—most commonly atrial fibrillation—but are not intended to detect ischemia or life-threatening cardiac events such as myocardial infarction. Major participants in this segment include:

KardiaMobile (AliveCor)
Apple Watch (Apple)
Pixel Watch (Google)
Galaxy Watch (Samsung)

While these devices benefit from broad consumer adoption and ease of use, their clinical utility is largely limited to rhythm screening. In contrast, HeartBeam™ is designed to acquire higher-resolution cardiac signals by synthesizing a full 12-lead ECG, enabling clinical-grade interpretation. Although HeartBeam is currently FDA-cleared for arrhythmia assessment, its architecture supports diagnostic applications beyond rhythm screening—capabilities that single-lead consumer wearables are not designed to address.

Prescription devices for ischemia detection

This segment consists of FDA-cleared ECG devices intended for use outside of traditional healthcare facilities that provide actionable information relevant to ischemic events, including myocardial infarction.

AngelMed GUARDIAN™ (Avertix Medical, Inc.) – An implantable cardiac monitoring system for patients at extremely high risk of myocardial infarction. GUARDIAN™ is an invasive solution requiring surgical implantation and carries a high upfront cost, limiting its use to a narrowly defined patient population.

SmartHeart® (SHL Telemedicine Ltd.) – A 12-lead ECG system designed for at-home use. SmartHeart® requires a multi-component setup, including an electrode belt, underarm electrodes, and a waist electrode, along with preparatory steps prior to recording. Its size and complexity make continuous portability impractical, limiting accessibility at the onset of symptoms.

HeartBeam™ occupies a distinct position within this landscape. As a non-surgical, low-cost solution that is immediately usable at the onset of symptoms, HeartBeam removes the traditional trade-off between invasiveness and portability seen in existing offerings. A future pivotal trial is intended to support an ischemia indication, which—if achieved—would position HeartBeam as a uniquely practical tool for early, patient-initiated ischemia detection.

COMMERCIALIZATION

The HeartBeam System currently lacks reimbursement, and the company’s initial commercialization strategy is therefore focused on cash-pay segments of the healthcare market, beginning with concierge and executive medicine. This approach allows HeartBeam to introduce the technology to a patient population that is both highly health-engaged and less constrained by reimbursement dynamics, while building early clinical adoption and real-world data.

Approximately 1.5 million Americans participate in concierge medicine, where patients pay annual membership fees in exchange for enhanced physician access and preventive care. These programs typically cost $3,000–$10,000 per year, with premium longevity-oriented practices charging $50,000 or more annually. Within this context, a patient-purchased cardiac monitoring system designed to provide immediate ECG insights during symptomatic episodes represents a logical extension of the preventive and monitoring services already offered in this market.

In company-conducted market research involving 231 high-net-worth individuals and 30 concierge and preventive cardiology physicians, 80% of patients indicated they would likely purchase the HeartBeam System, while 72% of physicians reported they would recommend the device to their patients. While preliminary, these findings suggest meaningful early receptivity within the target segment.

HeartBeam’s initial commercial focus is on physician-owned cardiology and executive concierge practices, typically serving 400 to 4,000 patients, concentrated in major concierge markets including New York, South Florida, Dallas, and Southern California. These geographies collectively represent roughly 10% of the overall concierge medicine market. The company recently announced its first commercial partnership with ClearCardio, a concierge cardiology provider serving a premium patient base in Dallas and New York.

Beyond individual practices, HeartBeam plans to pursue partnerships with national concierge networks, which typically serve 100,000 to 400,000 patients per network. Key players in this segment include MDVIP, SignatureMD, and Concierge Choice Physicians, which together represent a large, structurally organized channel for physician-mediated patient adoption.

Outside the concierge segment, HeartBeam also sees opportunity in the broader patient-pay cardiovascular monitoring market, including direct primary care networks, telehealth platforms, and physician referrals to HeartBeam diagnostic centers. The company estimates this segment includes approximately 3.5 million potential patients.

PRICING AND MARGINS

The HeartBeam system is expected to be priced at approximately $50–$75 per month on a subscription basis, in addition to an upfront fee for the device. The subscription includes access to the mobile app and physician portal, unlimited asymptomatic ECG recordings, and a defined number of cardiologist-interpreted reads. Higher-tier plans are available for patients requiring a greater volume of cardiologist reads.

Under this pricing structure, HeartBeam achieves a 3–5 month payback period on upfront device costs, followed by approximately 70% gross margins on the recurring subscription revenue. The company estimates cash-flow breakeven at approximately $20 million in annual gross profit, which corresponds to roughly 37,500 subscribed patients.

INTELLECTUAL PROPERTY

As of Q4 2026, HeartBeam has 14 issued US patents and 19 pending US applications covering compact ECG systems for remote detection and/or diagnosis of acute myocardial infarction.

The company also has 4 issued patents in Germany, France, Netherlands and United Kingdom and 24 pending applications in Canada, China, the European Union, Japan, South Korea and Australia.

ADDITIONAL PROGRAMS

HeartBeam has two additional programs in development: a On-Demand 12-Lead Patch and a Machine Learning program.

On-Demand 12-Lead Patch

The cardiac patch monitor market—comprising long-term continuous monitors and Mobile Cardiac Telemetry (MCT)—is an approximately $2 billion market with established reimbursement. These patches, typically worn for up to 30 days to continuously monitor cardiac rhythm, were developed to address the limitations of traditional Holter monitors, which rely on multi-lead configurations requiring multiple electrodes and wires and are therefore cumbersome for extended wear.

Most existing patch monitors, however, record only one to three leads, limiting their diagnostic utility largely to arrhythmia detection and monitoring.

HeartBeam has completed a working prototype of a cardiac patch that enables patients to place two fingers on the device to record a clinical-grade 12-lead ECG, which is transmitted in real time for physician review. This introduces the possibility of ischemia detection in a wearable patch format and, if successfully developed, could combine the diagnostic capability of a traditional 12-lead ECG with the convenience of continuous patch monitoring—potentially shifting share within the MCT market while expanding its clinical scope.

In company-conducted market research involving 78 physicians, 86% of physicians who currently prescribe patch monitors indicated they would switch patients to a 12-lead patch, while 94% of physicians who currently prescribe other monitoring modalities (such as Holter monitors) indicated they would switch a portion of patients.

HeartBeam currently has a prospective clinical study underway evaluating this device.

Machine Learning

Most machine learning models used in cardiac monitoring today are trained on ECG data collected in clinical environments, primarily hospitals and diagnostic centers. HeartBeam’s platform introduces the possibility of extending AI analysis into the patient’s daily environment, applying deep learning algorithms each time a patient records an ECG using a HeartBeam device. A system built on frequent patient-initiated recordings could enable the development of larger, more diverse datasets, potentially improving algorithm performance while supporting more personalized cardiovascular risk assessment.

With continuous access to patient-generated ECG data, HeartBeam’s platform may enable AI applications that extend beyond traditional symptom-driven diagnostics, such as arrhythmia detection or heart attack assessment. Over time, the company believes this data architecture could support the development of algorithms focused on disease prediction, longitudinal monitoring, and ongoing cardiovascular management, which could open additional clinical use cases and potential reimbursement pathways.

To support this effort, HeartBeam has established a strategic collaboration with Mount Sinai, which brings expertise in artificial intelligence and access to clinically annotated ECG datasets. The initial focus of the collaboration is the development of an AI algorithm designed to assist physicians in the assessment of heart attacks.

SOURCES

Shvilkin, A. Coronary Artery Occlusion Detection Using 3-Lead ECG System Suitable for Credit Card-Size Personal Device Integration. JACC Advances: Volume 2, Number 6.

Deering, T. Clinical validation of a cable-free portable synthesized 12-lead ECG System for at-home use : VALID-ECG Study, 2025. Heart Rhythm Society.

HeartBeam Investor Presentation January 2026: https://d1io3yog0oux5.cloudfront.net/_a7f553992ee73f0933ea9a841d53ecfa/heartbeam/db/2293/21733/pdf/HeartBeam+Investor+Presentation+January+2026+-+FINAL2.pdf

HeartBeam Financial Results Conference Call Q3 2025: https://d1io3yog0oux5.cloudfront.net/_a7f553992ee73f0933ea9a841d53ecfa/heartbeam/db/2293/21725/pdf/BEAT+Q3%2725+Earnings+Conference+Call+Presentation_FINAL.pdf

HeartBeam Financial Results Conference Call Q4 2025:
https://d1io3yog0oux5.cloudfront.net/_cfdcdad7a1fa42dac3544d4d0d03c2d2/heartbeam/db/2317/21736/earnings_presentation/BEAT+Q4%2725+Earnings+Conference+Call+Presentation_FINAL+3-12-2026.pdf

HeartBeam Annual Report 10-K 2025: https://ir.heartbeam.com/sec-filings/annual-reports##document-387-0001628280-25-012614-2

HeartBeam Inc

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