HeartBeam, Inc. (NASDAQ: BEATW)

HeartBeam is a medical technology company focused on transforming cardiac care through the power of personalized insights. The company develops higher resolution ambulatory cardiac monitoring solutions that enable detection and monitoring of cardiac disease outside healthcare facilities. Its core innovation lies in a proprietary patented technology platform that collects the heart’s electrical activity from three dimensions and synthesizes a 12-Lead ECG from these signals. HeartBeam’s initial product and service offering is the HeartBeam System, which is the first U. S. FDA cleared cable-free ambulatory 12L ECG that captures cardiac signals in three dimensions for high-fidelity data collection and advanced diagnostics for arrhythmia assessment. The system includes a credit card sized 3D ECG recording device, a patient application, a physician portal, and cloud-based algorithms.

HeartBeam generates revenue through the sale of its HeartBeam System and associated services. The primary product is the FDA cleared cable-free ambulatory 12L ECG device designed for arrhythmia assessment. Revenue is derived from the sale of the hardware device, patient application access, physician portal usage, and cloud-based algorithm services. The company targets customers seeking convenient cardiac monitoring solutions outside traditional healthcare settings. As of December 31, 2025, HeartBeam had not generated any revenue from the HeartBeam System, as it was focused on post-clearance commercialization activities following FDA clearance in December 2024 for arrhythmia assessment and December 2025 for the 12-Lead ECG synthesis software.

The company operates through the following segments:

• HeartBeam System segment. This segment encompasses the development, manufacturing, and commercialization of the HeartBeam System, which includes the credit card sized 3D ECG recording device, patient application, physician portal, and cloud-based algorithms for synthesizing a 12-Lead ECG from three-dimensional cardiac signals. The segment focuses on arrhythmia assessment and is supported by FDA clearances obtained in December 2024 and December 2025. Activities include limited market launch in early 2026 targeting concierge and preventive cardiology groups, pursuit of heart attack detection indication, development of an extended wear patch monitor, and longitudinal data and AI initiatives for future screening and prediction algorithms.

HeartBeam operates in a competitive cardiac monitoring and detection market characterized by rapid technological change. The company faces competition from consumer devices such as Apple Watch, AliveCor’s KardiaMobile, Google Pixel 2, and Samsung Galaxy Watch, which are single-lead ECG devices primarily intended for arrhythmia detection and not ischemia detection. In the prescribed devices for ischemia detection segment, competitors include Avertix Medical’s AngelMed Guardian implantable cardiac monitor and SHL Telemedicine’s Smartheart home-based 12L ECG system. Patch monitoring companies such as iRhythm Technologies, Boston Scientific’s BodyGuardian, and BioTelemetry (a Philips subsidiary) offer single or 3-lead ECG patches limited to arrhythmia detection. HeartBeam differentiates itself through its patented cable-free technology that captures cardiac signals in three non-coplanar dimensions and synthesizes them into a 12-Lead ECG display, offering a portable, easy-to-use solution that provides comprehensive diagnostic data comparable to standard 12L ECG machines. Its competitive advantages include the credit card sized form factor, personalized baseline ECG capability, and integration with on-demand cardiologist review.

HeartBeam serves customers in the cardiac monitoring market, including patients, healthcare providers, and healthcare payers. The company’s primary customers are concierge physicians, preventive cardiology practices, and cardiology departments of hospitals. Healthcare insurers are also an important customer segment due to potential cost savings to the healthcare system. The company targets market segments that value an easy-to-use medical-grade ECG device, including concierge practices, hospital-at-home programs, and clinical trial settings. HeartBeam aims to establish its products as key solutions for these customers through clinical evidence, cost-effectiveness demonstrations, and reference site development.