HeartBeam, Inc.

HeartBeam, Inc. is a medical technology company focused on transforming cardiac care through personalized insights, specifically by developing higher resolution ambulatory cardiac monitoring solutions. The company's core business model revolves around its proprietary and patented technology platform that collects the heart's electrical activity from three dimensions and synthesizes a 12-Lead (12L) ECG from these signals. This technology aims to enable the detection and monitoring of cardiac disease outside of a healthcare facility, offering convenience and high-fidelity insights compared to traditional 12L ECGs which are typically limited to healthcare settings. The company believes its products and services will benefit patients, healthcare providers, and payers, addressing the rapidly growing field of ambulatory cardiac monitoring. HeartBeam is uniquely positioned to play a central role in high-risk Coronary Artery Disease (CAD) monitoring, supported by initial feasibility studies demonstrating comparable performance of the HeartBeam System to standard 12L ECG in ischemia detection. The company's primary customers are concierge physicians, preventative cardiology practices, and cardiology departments of hospitals, with healthcare insurers also being an important customer segment due to potential cost reductions. The company's initial market strategy involves establishing clinical evidence and demonstrating cost-effectiveness, targeting segments where payment for the device will be outside the established reimbursement system, such as concierge practices, hospital-at-home, and clinical trials.

HeartBeam's initial product and service offering is the HeartBeam System, which is the first U.S. Food and Drug Administration (FDA) cleared cable-free, ambulatory 12L ECG for arrhythmia assessment. This system comprises a credit card-sized 3D ECG recording device, a patient application, a physician portal, and cloud-based algorithms. 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. The HeartBeam System did not generate any revenue in 2025. The company's technology is backed by robust clinical data, including the VALID-ECG pivotal study, which showed a 93.4% overall diagnostic agreement for arrhythmia detection between HeartBeam's synthesized 12L ECG and a standard 12L ECG. Additionally, a landmark clinical study published in JACC: Advances in August 2023 demonstrated that HeartBeam technology detects coronary occlusion with the same accuracy as a standard 12L ECG, with the novel feature of a "normal baseline" recording dramatically improving diagnostic performance from an Area Under the Curve of 0.72 to 0.95.

For the fiscal year ended December 31, 2025, HeartBeam reported a net loss of $(21,015) thousand ¹, an increase of 8% from a net loss of $(19,448) thousand ² in 2024. Total operating expenses for 2025 were $21,139 thousand ³, up 6% from $19,887 thousand ⁴ in 2024. This resulted in a loss from operations of $(21,139) thousand ⁵ in 2025, compared to $(19,887) thousand ⁶ in 2024. The company generated no revenue in 2025. Basic and diluted net loss per share for 2025 was $(0.62) ⁷, an improvement from $(0.73) ⁸ in 2024. As of December 31, 2025, cash and cash equivalents stood at $4,380 thousand ⁹, an increase from $2,377 thousand ¹⁰ as of December 31, 2024. The company had no total debt explicitly stated, but current liabilities were $3,240 thousand ¹¹ as of December 31, 2025, compared to $1,622 thousand ¹² in 2024.

Year-over-year, general and administrative (G&A) expenses decreased by $1,147 thousand ¹³, or 13%, to $7,689 thousand ¹⁴ in 2025 from $8,836 thousand ¹⁵ in 2024. This decrease was primarily due to a $0.6 million ¹⁶ reduction in non-cash stock-based compensation expense, $0.4 million ¹⁷ lower consulting costs related to finance, and $0.3 million ¹⁸ lower employee costs, partially offset by a $0.2 million ¹⁹ increase in consulting costs for commercial readiness. Research and development (R&D) expenses increased by $2,399 thousand ²⁰, or 22%, to $13,450 thousand ²¹ in 2025 from $11,051 thousand ²² in 2024. This increase was mainly driven by a $1.5 million ²³ rise in product development costs for the HeartBeam System, a $1.2 million ²⁴ increase in headcount-related costs due to reallocation into AI and R&D, and a $1.4 million ²⁵ increase in non-cash stock-based compensation expense, partially offset by a $0.7 million ²⁶ decrease in clinical-related costs and a $1.0 million ²⁷ decrease in consulting expenses related to foundational clearance. Other income decreased by $315 thousand ²⁸, or 72%, to $124 thousand ²⁹ in 2025 from $439 thousand ³⁰ in 2024, primarily due to a decreased cash balance used in operations.

Significant operational developments during the period include the FDA clearance of HeartBeam's credit card-sized 3D ECG technology for arrhythmia assessment in December 2024 and the 12-Lead ECG synthesis software in December 2025. The company is initiating a limited market introduction in early 2026, focusing on select concierge and preventive cardiology groups. In January 2026, Bryan Humbarger was hired as Chief Commercial Officer, bringing the total headcount to 17 employees ³¹. The company announced ClearCardio as its first commercial customer on March 4, 2026, with an initial staged rollout and plans for broader expansion. On March 5, 2026, the first patients were enrolled in the ALIGN-ACS study, a pilot study designed to enroll 100 patients presenting with chest pain in the emergency room to assess heart attack detection. A strategic AI collaboration with the Icahn School of Medicine at Mount Sinai was announced on March 10, 2026, to accelerate personalized cardiac AI development on the HeartBeam platform. The company also significantly strengthened its intellectual property portfolio, being granted eight new patents in 2025 and early 2026, and filing two non-provisional, three provisional, and three continuing patent applications throughout 2025.

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. This initial release aims to validate real-world performance and establish reference sites for broader commercialization. The company does not anticipate needing a large sales force during this initial launch, believing a few well-placed resources will provide the necessary data points for a broader, scalable launch leading to profitable growth.

A major growth area for HeartBeam is the expansion of its cleared indications to include heart attack detection. This initiative is supported by compelling proof-of-concept data and represents a significant market opportunity, potentially reaching tens of millions of patients in the U.S. The ALIGN-ACS pilot study, which enrolled its first patients on March 5, 2026, is a key step towards this FDA indication expansion. This study is designed to enroll 100 patients presenting with chest pain in the emergency room, comparing standard 12-lead ECG and HeartBeam device results with final diagnoses.

Another significant growth vector is the development of an on-demand 12L ECG extended wear patch monitor. The company has developed a working prototype of this novel 12L patch, which it believes has the potential to be a best-in-class offering in an existing multi-billion-dollar market with established reimbursement. This patch aims to provide standard of care 12L ECG capabilities in a form factor similar to current single-lead ECG patches, addressing a critical market gap.

HeartBeam also plans to leverage its unique data-rich repository generated from its 3D ECG platform and deep learning algorithms. As product adoption grows and patients record synthesized 12L ECGs over time, the company sees an opportunity to build AI-based screening and prediction algorithms that surpass the capabilities of single-timepoint ECGs or traditional wearables. A strategic AI collaboration with the Icahn School of Medicine at Mount Sinai, announced on March 10, 2026, aims to accelerate the development of personalized cardiac AI on the HeartBeam platform for wellness and clinical applications, including assessing heart attack risk. The company expects AI development efforts to quickly become one of its major R&D focuses.

Regarding its operational outlook, HeartBeam's manufacturing strategy is designed to scale with its commercial phases. The company 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. This positions the company to support initial commercial launch volumes as final validation activities are completed. The device architecture primarily uses off-the-shelf components, providing supply chain flexibility. The company owns all proprietary molds and tooling for key plastic components, offering additional manufacturing flexibility. HeartBeam's manufacturing approach supports its targeted cost of goods sold and gross margin objectives, with potential for further cost reductions through volume scaling, supply chain optimization, and operational efficiencies. Logistics and fulfillment capabilities have been established through a third-party logistics (3PL) partner for commercial distribution, inventory management, and post-market activities.

For capital allocation, HeartBeam expects to continue devoting capital resources to R&D for software and hardware product development, and to sales and marketing for the limited launch and commercial strategy of its HeartBeam System. The company had approximately $4.4 million ³² in cash and cash equivalents as of December 31, 2025. Subsequent to December 31, 2025, the company raised $1.5 million ³³ from net proceeds under its At-the-Market (ATM) sales agreement. As of March 11, 2026, approximately $8.1 million ³⁴ was available for issuance under the ATM program.

Management explicitly flagged that the company's existing working capital is insufficient to fund operations for the next twelve months following the issuance of the financial statements, raising substantial doubt about its ability to continue as a going concern. The company's continued operations depend on its ability to raise additional capital through equity and/or debt financings or strategic relationships until sufficient revenue can be generated to achieve positive cash flow. There is no assurance that such financing or strategic relationships will be available on acceptable terms, or at all. The company also faces risks related to its limited operating history, the difficulty in accurately forecasting future revenues for a new business in an undeveloped market, and the potential inability to adjust spending in a timely manner for unanticipated revenue reductions.

HeartBeam faces several material risks across macroeconomic, competitive, regulatory, geopolitical, and operational domains. Macroeconomic risks include the requirement for additional capital to support its business plan and growth, with no assurance that such capital will be available on acceptable terms, or at all, which could lead to curtailment or termination of business plans. The company has a limited operating history and no revenues, making future profitability uncertain and potentially forcing a curtailment of R&D programs and day-to-day operations. Competitive risks are significant due to the highly competitive cardiac monitoring and detection market, characterized by rapid technological change and numerous companies with greater resources. Competitors may develop superior products, respond faster to new technologies, or undertake more extensive marketing campaigns. The company also faces competition from other medical device companies with longer operating histories, greater name recognition, and more extensive resources. Regulatory risks are substantial, as the company's products are subject to extensive governmental regulations by the FDA and foreign authorities. There is a risk that the FDA may reclassify the company's Class II medical devices as Class III, significantly increasing regulatory costs and delaying market entry. Changes in FDA policies or additional government regulations could prevent or delay regulatory approval and increase compliance costs. Furthermore, the company's ability to obtain and maintain adequate third-party reimbursement for its products is critical, and changes in reimbursement practices or refusal by commercial payers to cover new technologies could materially adversely affect its business. Geopolitical risks include escalating global trade tensions, the Russia and Ukraine war, and the Israel-Hamas war, which could lead to disruption, instability, and volatility in global markets, potentially increasing costs or reducing sales. Operational risks include product defects leading to recalls or product liability claims, interruptions or delays in telecommunications or data services, and failures in cloud-based computational and data management systems, all of which could harm the business and operating results. The company's dependence on a limited number of suppliers for components also poses a risk of delays or interruptions in supply. Cybersecurity risks are present, with the potential for security incidents, cyberattacks, or data breaches harming the business, operating results, and financial condition.

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) as major milestones. The overall tone is one of cautious optimism, acknowledging the significant progress made in product development and regulatory achievements, while also explicitly addressing the critical need for additional capital. Management's strategic priorities for the period ahead include initiating a limited market launch in early 2026, focusing on select concierge and preventive cardiology groups to validate real-world performance and establish reference sites. A second key priority is pursuing an expansion of cleared indications through a heart attack detection indication, supported by compelling proof-of-concept data and representing a major expansion opportunity to tens of millions of patients in the U.S. The third strategic priority is making significant advancements with an on-demand 12L ECG extended wear monitor, with a working prototype already developed, which management believes has the potential to be a best-in-class offering in an existing multi-billion-dollar market with reimbursement. Additionally, management is focused on unlocking the power of the unique data-rich repository from its 3D ECG platform and deep learning algorithms, aiming to build AI-based screening and prediction algorithms as adoption grows. Management explicitly states that the company's existing cash of approximately $4.4 million ³⁵ as of December 31, 2025, is insufficient to fund operations for the next twelve months, and that continued operations depend on raising additional capital through equity and/or debt financings or strategic relationships.