HeartBeam, Inc.

HeartBeam, Inc. is a medical technology company focused on transforming cardiac care through personalized insights by developing higher-resolution ambulatory cardiac monitoring solutions. The company's proprietary and patented technology platform collects the heart's electrical activity from three dimensions and synthesizes a 12-Lead (12L) ECG from these signals, aiming to enable detection and monitoring of cardiac disease outside of a healthcare facility ¹. HeartBeam believes its products and services will benefit patients, healthcare providers, and payers, addressing the rapidly growing field of ambulatory cardiac monitoring. The company is uniquely positioned for high-risk Coronary Artery Disease (CAD) monitoring, supported by proof-of-concept data demonstrating comparable performance of the HeartBeam System to standard 12L ECG in ischemia detection ². The global Connected Medical Device Market is estimated at $66 billion in 2024 and is expected to reach $133 billion by 2029, growing at a compounded annual growth rate (CAGR) of 15% ³. The market for cardiac monitoring technologies is projected to reach approximately $18 billion by 2030, a CAGR of approximately 8% ⁴.

The core business model revolves around the HeartBeam System, an FDA-cleared cable-free, ambulatory 12L ECG device. This system captures cardiac signals in three non-coplanar dimensions and synthesizes them into a 12L ECG display using a personalized transformation matrix ⁵. This allows patients to obtain a 12L ECG reading for arrhythmia assessment from home, with the synthesized ECG promptly reviewed by an on-demand, board-certified cardiologist ⁶. The HeartBeam System did not generate any revenue in 2025 ⁷. Primary customer segments include concierge physicians, preventative cardiology practices, and cardiology departments of hospitals, with healthcare insurers also identified as important beneficiaries due to potential cost reductions ⁸. The company's long-term strategy involves generating clinical and cost-effectiveness evidence to partner with health insurance companies for coverage ⁹.

The HeartBeam System comprises a credit card-sized 3D ECG recording device, a patient application, a physician portal, and cloud-based algorithms ¹⁰. The device captures cardiac signals in 3D and transmits them via Bluetooth to a smartphone ¹¹. The cloud-based software performs ECG signal quality checks, synthesizes a 12L ECG from the 3D ECG, and prepares a summary report for physicians, including an overlay of the patient's synthesized baseline 12L ECG waveform for more accurate interpretation ¹². A dedicated team of cardiologists provides 24/7/365 services for recommended courses of action based on ECG signals, symptoms, and patient history ¹³. The credit card-sized 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 ¹⁴.

For the fiscal year ended December 31, 2025, HeartBeam reported total operating expenses of $21,139 thousand ¹⁵, an increase of $1,252 thousand or 6% compared to $19,887 thousand in 2024 ¹⁶. The company incurred a net loss of $21,015 thousand ¹⁷, an 8% increase from the net loss of $19,448 thousand in 2024 ¹⁸. Basic and diluted net loss per share was $(0.62) ¹⁹ for 2025, compared to $(0.73) ²⁰ in 2024. As of December 31, 2025, cash and cash equivalents were $4,380 thousand ²¹, an increase of $2,003 thousand from $2,377 thousand as of December 31, 2024 ²². Net cash used in operating activities was $(13,988) thousand ²³ in 2025, compared to $(14,471) thousand in 2024 ²⁴. Net cash used in investing activities was $(600) thousand ²⁵ in 2025, primarily due to the purchase of property and equipment, compared to $(201) thousand in 2024 ²⁶. Net cash provided by financing activities was $16,591 thousand ²⁷ in 2025, primarily from the net proceeds from the sale of equity, compared to $866 thousand in 2024 ²⁸.

General and administrative (G&A) expenses decreased by $1,147 thousand, or 13%, to $7,689 thousand in 2025 from $8,836 thousand in 2024 ²⁹. This decrease was primarily due to a $0.6 million reduction in non-cash stock-based compensation expense, $0.4 million lower consulting costs, and $0.3 million lower employee costs, partially offset by a $0.2 million increase in commercial readiness consulting costs ³⁰. Research and development (R&D) expenses increased by $2,399 thousand, or 22%, to $13,450 thousand in 2025 from $11,051 thousand in 2024 ³¹. This increase was mainly driven by a $1.5 million rise in product development costs for the HeartBeam System, a $1.2 million increase in headcount-related costs due to reallocation into AI and R&D, and a $1.4 million increase in non-cash stock-based compensation expense, partially offset by a $0.7 million decrease in clinical-related costs and a $1.0 million decrease in foundational clearance consulting expenses ³². Interest income decreased by $324 thousand, or 73%, to $122 thousand in 2025 from $446 thousand in 2024, primarily due to a decreased cash balance used in operations ³³.

During 2025 and early 2026, HeartBeam was granted eight new patents related to its compact, mobile three-lead cardiac monitoring technologies and automated diagnostics, methods for atrial fibrillation detection, photoplethysmogram data analysis and presentation, and electrocardiogram patch devices and methods ³⁴. The company also filed two non-provisional, three provisional, and three continuing patent applications throughout 2025 ³⁵. In January 2026, Bryan Humbarger was hired as Chief Commercial Officer, bringing the total headcount to 17 employees ³⁶. On March 4, 2026, HeartBeam announced ClearCardio as its first commercial customer, with an initial staged rollout and plans for broader expansion to thousands of members across multiple U.S. geographies, structured as a Letter of Intent with a subscription fee per patient ³⁷. On March 5, 2026, the company enrolled the first patients in the ALIGN-ACS study, a pilot study designed to enroll 100 chest pain patients in the emergency room to compare HeartBeam device results with standard 12-lead ECG and final diagnosis, aiming for a future FDA indication expansion for heart attack assessment ³⁸. On March 10, 2026, HeartBeam entered into a strategic AI collaboration with the Icahn School of Medicine at Mount Sinai to accelerate the development of personalized cardiac AI on the HeartBeam platform for wellness and clinical applications, including heart attack risk assessment ³⁹.

HeartBeam is initiating a limited market introduction of its FDA-cleared HeartBeam System in early 2026, targeting select concierge and preventive cardiology groups that have expressed strong interest ⁴⁰. This initial release aims to validate real-world performance and establish reference sites for broader commercialization ⁴¹. The company is pursuing an expansion of its cleared indications to include heart attack detection, supported by compelling proof-of-concept data, which represents a major expansion opportunity to tens of millions of patients in the U.S. ⁴².

A significant growth area is the advancement of an on-demand 12L ECG extended wear monitor, for which the company has developed a working prototype of its novel 12L patch ⁴³. This patch has the potential to be a best-in-class offering in an existing multi-billion-dollar market with reimbursement ⁴⁴. The company believes this technology will fill a diagnostic gap by offering a 12-lead equivalent ECG signal within a patch form factor, providing significant diagnostic advantages over existing single-lead ECG patch products ⁴⁵.

Another key growth vector involves unlocking the power of the unique data-rich repository generated from its 3D ECG platform and deep learning algorithms ⁴⁶. As adoption of the HeartBeam System grows, the ability for patients to record synthesized 12L ECGs over time will create the opportunity to build AI-based screening and prediction algorithms that go beyond what is possible with single-timepoint ECGs or traditional wearables ⁴⁷. The company also plans to integrate a synthesized 12-lead ECG smartwatch-based monitor for the detection of heart attacks and complex cardiac arrhythmias, aiming to eliminate the need for a dedicated ECG device ⁴⁸. The AI team has developed a roadmap for AI-based tool development, which is expected to quickly become one of the major R&D efforts ⁴⁹.

Operationally, HeartBeam intends to balance managing its headcount with cash resources, hiring or engaging additional full-time professionals, employees, and/or consultants in alignment with its growth strategy at the appropriate time ⁵⁰. The company does not anticipate the need for a large sales force during the initial launch of its HeartBeam System, believing that a few well-placed resources will provide the data points needed for effective investment into a broader, scalable launch model for profitable growth ⁵¹. The company expects its value proposition to increase as it adds functionality to its monitoring solutions and drives down costs through increased scale and automation ⁵².

The company's manufacturing strategy is designed to scale with commercial phases, from initial limited launch volumes to broader market adoption ⁵³. HeartBeam has partnered with a U.S.-based contract manufacturing (CM) organization and has substantially completed key phases of the design transfer process, including installation and qualification of production tooling and test fixtures, and first article builds ⁵⁴. The device architecture primarily uses off-the-shelf components for supply chain flexibility, and the company owns all proprietary molds and tooling for key plastic components ⁵⁵. This manufacturing approach supports targeted cost of goods sold and gross margin objectives, with potential for further cost reductions through volume scaling, supply chain optimization, and operational efficiencies ⁵⁶. Logistics and fulfillment capabilities have been established through a third-party logistics (3PL) partner to support commercial distribution, inventory management, and post-market activities ⁵⁷.

HeartBeam's cash requirements will continue to be dependent on R&D for software and hardware products and sales & marketing for the limited launch and commercial strategy of the HeartBeam system ⁵⁸. As of March 11, 2026, approximately $8.1 million was available for issuance under the At-the-Market (ATM) sales agreement ⁵⁹. The company believes that continued achievement of clinical and regulatory milestones will provide the ability to raise additional capital ⁶⁰.

HeartBeam faces substantial doubt about its ability to continue as a going concern, as existing working capital is insufficient to fund operations for the next twelve months following the issuance of the annual report ⁶¹. The company has a limited operating history and no revenues, making it difficult to forecast future revenues and achieve sustained profitability ⁶². There is no assurance that additional capital will be available on acceptable terms, or at all, and any future financing may be dilutive to current stockholders ⁶³. The company's business is dependent on physicians utilizing and prescribing its solution, and failure to engage physicians or obtain adequate third-party reimbursement could prevent revenues from materializing or meeting projections ⁶⁴. The medical technology industry is highly competitive and subject to rapid technological change, with many competitors having significantly greater financial and marketing resources ⁶⁵. Product defects, interruptions in telecommunications or cloud systems, and cybersecurity incidents could lead to significant liability claims, recalls, reputational damage, or disruptions in service ⁶⁶. The company is subject to extensive governmental regulations, and reclassification of its Class II medical products to Class III could significantly increase regulatory costs and delay marketing ⁶⁷. Changes in tax laws or regulations, escalating global trade tensions, and natural disasters or public health crises could also adversely affect operations and financial results ⁶⁸.

Management's message to shareholders emphasizes the company's focus on transforming cardiac care through personalized insights and innovative, higher-resolution ambulatory cardiac monitoring solutions. They highlight the recent FDA clearances for the HeartBeam System's credit card-sized 3D ECG technology (December 2024) and 12-Lead ECG synthesis software (December 2025) for arrhythmia assessment as major milestones ⁶⁹. The overall tone is forward-looking, with a clear focus on advancing several key initiatives as part of their growth strategy. These strategic priorities include a limited market launch in early 2026 targeting concierge and preventive cardiology groups to validate real-world performance and establish reference sites ⁷⁰. A second priority is pursuing an expansion of cleared indications through a heart attack detection indication, which management views as a major expansion opportunity to tens of millions of patients in the U.S. ⁷¹. The third key strategic priority is making significant advancements with an on-demand 12L ECG extended wear monitor, for which a working prototype of a novel 12L patch has been developed, with the potential to be a best-in-class offering in an existing multi-billion-dollar market with reimbursement ⁷². Management also stresses the ability to unlock the power of the unique data-rich repository generated from their 3D ECG platform and deep learning algorithms, aiming to build AI-based screening and prediction algorithms as adoption grows ⁷³. The company explicitly states that its existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements, raising substantial doubt about its ability to continue as a going concern ⁷⁴. However, management believes the continued achievement of clinical and regulatory milestones will provide the ability to raise additional capital ⁷⁵.