HeartBeam Reports Third Quarter 2026 Financial Results, Advances Heart Attack Assessment Strategy and Prepares for Pivotal U.S. Study
HeartBeam, a medical technology company focused on transforming cardiac care through personalized cardiac insights, has announced its financial and operational results for the third quarter ended September 30, 2026. The company also provided updates on its clinical development programs, regulatory progress, and strategic priorities, highlighting significant advancements in its efforts to expand the use of its HeartBeam System for heart attack assessment.
During the third quarter and subsequent months, HeartBeam made substantial progress in advancing its strategy to address myocardial infarction (MI), commonly known as a heart attack. Following a strategic decision in September 2026 to allocate most of its financial and personnel resources toward heart attack assessment, the company achieved several important milestones. These included receiving U.S. Food and Drug Administration (FDA) Breakthrough Device Designation, gaining acceptance into the FDA’s Total Product Life Cycle Advisory Program (TAP), completing enrollment in its HEADSTART-ACS clinical study, and presenting encouraging pilot study results from ALIGN-ACS at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) conference.
Building on these developments, HeartBeam plans to finalize the design of its U.S. pivotal clinical study during the fourth quarter of 2026, with patient enrollment expected to begin in the first quarter of 2027. The planned study is intended to generate clinical evidence supporting a future FDA submission to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack assessment.
Heart Attack Assessment Becomes HeartBeam’s Primary Strategic Focus
In September 2026, HeartBeam announced a strategic shift designed to concentrate the majority of its resources on developing its technology for heart attack assessment. The company believes this opportunity represents its most significant potential source of long-term value creation, given the substantial number of people at risk of experiencing a heart attack and the limitations of existing cardiac assessment approaches outside traditional healthcare settings.
According to the company, more than 20 million adults in the United States are at elevated risk of a heart attack. HeartBeam estimates that this potential patient population is approximately four times larger than the market opportunity associated with cardiac arrhythmia assessment.
The company estimates the addressable market for myocardial infarction assessment at approximately $15 billion. When combined with its broader cardiac technology platform opportunities, the overall potential market could exceed $40 billion.
HeartBeam’s strategy centers on making clinically meaningful cardiac information more accessible to patients and healthcare professionals, particularly when symptoms develop outside hospitals or emergency departments. Conventional heart attack assessment generally relies on a standard 12-lead electrocardiogram (ECG), which is typically performed in a clinical environment and requires trained personnel and specialized equipment.
Through its portable, cable-free ECG technology, HeartBeam aims to provide patients with an additional way to obtain cardiac information outside conventional healthcare facilities. The company believes this approach could help patients and physicians make more informed decisions when potential heart attack symptoms occur.
FDA Breakthrough Device Designation Strengthens Regulatory Progress
HeartBeam achieved several important regulatory milestones in October 2026, strengthening its development pathway for the heart attack assessment indication.
The FDA granted Breakthrough Device Designation to the HeartBeam System for assessing potential heart attacks in the home setting. Notably, the designation was received within 30 days of the company’s request, ahead of the agency’s statutory 60-day review period.
The FDA Breakthrough Devices Program is designed to support the development and regulatory review of medical technologies that have the potential to provide more effective treatment or diagnosis for serious or life-threatening conditions. The designation can facilitate communication with the FDA and provide opportunities for more frequent interactions during product development and regulatory evaluation.
For HeartBeam, the designation represents an important regulatory milestone as it works toward establishing a new role for its technology in cardiac assessment outside traditional clinical environments.
In October, the company also announced that its HeartBeam System had been accepted into the FDA’s Total Product Life Cycle Advisory Program. The TAP program is intended to encourage early engagement between medical device developers and regulatory stakeholders throughout the product development and commercialization process.
Through TAP participation, HeartBeam will have access to dedicated FDA advisors and opportunities for earlier engagement with healthcare stakeholders, including payers such as the Centers for Medicare & Medicaid Services (CMS). This interaction is expected to help the company better understand regulatory, reimbursement, and commercialization considerations as it advances its heart attack assessment technology.
Additionally, HeartBeam reached alignment with the FDA on a 510(k) regulatory pathway for the heart attack assessment indication in October 2026.
The company intends to use this regulatory pathway to support the potential expansion of the HeartBeam System’s existing indication. Its planned U.S. pivotal clinical study will be an important component of the evidence-generation process.
HeartBeam expects to complete the pivotal study design in the fourth quarter of 2026, incorporating findings from its ALIGN-ACS pilot study. The company currently plans to initiate patient enrollment in the first quarter of 2027.
ALIGN-ACS Pilot Study Demonstrates Encouraging Results
Another significant development during the reporting period was the presentation of positive pilot study results from ALIGN-ACS at TCT 2026 in San Diego, California.
The findings were presented by Graham Nichol, MD, MPH, FRCP(C), of the University of Washington. The study evaluated the diagnostic performance of the HeartBeam System compared with a conventional 12-lead ECG for assessing acute coronary syndrome (ACS), a group of conditions associated with reduced blood flow to the heart.
ALIGN-ACS enrolled 132 adults who presented with chest pain at the emergency departments of two major cardiology centers in Belgrade, Serbia.
The study was designed to compare the diagnostic accuracy of ECG recordings obtained using the HeartBeam System with recordings from standard 12-lead ECG equipment.
Eight cardiologists independently interpreted both sets of recordings while remaining blinded to each patient’s diagnosis. Their interpretations were subsequently compared with the final diagnoses established by an independent panel consisting of three cardiologists.
The study produced several findings that HeartBeam believes support the potential clinical utility of its technology.
One of the most notable outcomes was the higher specificity demonstrated by the HeartBeam System compared with the standard 12-lead ECG. HeartBeam achieved specificity of 81.8%, compared with 71.4% for the conventional ECG. Its sensitivity was 60.2%, compared with 63.0% for the standard 12-lead ECG.
These findings indicate that the HeartBeam System demonstrated comparable sensitivity alongside higher specificity in the overall study population. The company believes this performance could support the technology’s potential role as a diagnostic aid, particularly when helping healthcare professionals evaluate patients with suspected acute coronary syndrome.
The study also evaluated performance in patients with ST-elevation myocardial infarction (STEMI), one of the most time-sensitive forms of heart attack that requires rapid medical assessment and treatment.
For STEMI assessment, the HeartBeam System demonstrated sensitivity of 82.9%, compared with 83.8% for the standard 12-lead ECG. These results indicate comparable sensitivity between the two approaches in identifying this critical condition within the study.
Another important finding involved the consistency of cardiologists’ interpretations. The agreement among physicians was higher when interpreting HeartBeam recordings, with a Fleiss’ kappa value of 0.73. In comparison, the standard 12-lead ECG produced a Fleiss’ kappa value of 0.54.
Higher agreement among independent readers suggests that the HeartBeam recordings may provide a more consistent basis for interpretation in the evaluated study setting.
Patient usability was also an important component of the ALIGN-ACS investigation. All participating patients, representing 100% of the study population, successfully recorded their own HeartBeam ECG under clinical supervision without receiving prior training.
The company views this finding as particularly relevant to its strategy of bringing cardiac assessment capabilities closer to patients. The ability to operate the device without extensive training could support potential use in home environments and other settings outside conventional healthcare facilities.
Although the results are encouraging, further clinical investigation will be necessary to establish the system’s performance and determine its appropriate role in heart attack assessment.
HEADSTART-ACS Study Completes Enrollment Ahead of Schedule
HeartBeam also expanded its clinical evidence base through the completion of enrollment in its HEADSTART-ACS study in October 2026.
The study represents the company’s largest heart attack assessment investigation to date using HeartBeam technology. It enrolled 486 patients presenting with chest pain at the emergency department of the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia.
Completing enrollment ahead of schedule represents an important operational milestone as HeartBeam continues to build the clinical evidence needed to advance its technology toward broader regulatory applications.
Indonesia provides a strategically important setting for the study. As the world’s fourth most populous country, it has a population of approximately 288 million people and represents a significant healthcare market.
The completion of HEADSTART-ACS, together with the previously conducted ALIGN-ACS pilot study, means HeartBeam now has clinical experience involving more than 600 patients in heart attack assessment.
The combined clinical experience is expected to contribute to the company’s ongoing evaluation of the HeartBeam System and help inform the design of its upcoming U.S. pivotal study.
By building evidence across multiple clinical settings and patient populations, HeartBeam aims to strengthen its understanding of how its technology may be used in evaluating patients with suspected cardiac events.
Participation in EU-Funded EXIT-CVD Research Consortium
In October 2026, HeartBeam announced that it had joined the EU-co-funded EXIT-CVD research consortium as a contributing partner.
The consortium includes several established global healthcare and medical technology organizations, including Philips, Medtronic, and GE HealthCare, alongside other participating organizations.
As part of the collaboration, HeartBeam will lead the HEART-CHECK study, one of 22 clinical studies being conducted under the EXIT-CVD initiative.
The HEART-CHECK study will evaluate the HeartBeam System for the early detection and triage of cardiac events among high-risk patients who have recently been discharged following an acute coronary syndrome.
Patients recovering after an acute coronary event may remain at risk of additional cardiac complications, making continued monitoring and timely identification of potential problems important aspects of post-discharge care.
Through HEART-CHECK, HeartBeam intends to investigate whether its portable ECG technology can contribute to earlier identification and assessment of cardiac events in this population.
Participation in EXIT-CVD also provides the company with an opportunity to collaborate with established medical technology organizations and contribute to a broader research effort focused on cardiovascular disease detection and management.
Patent Portfolio Expansion Supports Future Cardiac Applications
Beyond its heart attack assessment program, HeartBeam continues to strengthen its intellectual property portfolio and explore additional applications for its technology platform.
In July 2026, the company received a new U.S. patent covering the integration of acoustic sensing and thoracic impedance measurement into its existing ECG hardware platform.
The patented technology could support future applications involving structural heart disease and heart failure monitoring.
Acoustic sensing and thoracic impedance measurements can provide different types of physiological information that may complement conventional ECG data. Integrating these capabilities into HeartBeam’s existing hardware platform could create opportunities to expand the range of cardiac information available through its technology.
The company’s intellectual property portfolio now includes 26 issued patents worldwide.
HeartBeam believes its expanding patent portfolio provides a foundation for future innovation and may support the development of additional applications across cardiovascular disease assessment and monitoring.
Third Quarter 2026 Financial Performance
HeartBeam also reported its financial position for the third quarter ended September 30, 2026.
As of September 30, 2026, the company held cash and cash equivalents totaling $6.1 million, compared with $4.4 million as of December 31, 2025.
The company reported net cash used in operating activities of $2.6 million during the third quarter of 2026. This represented a 23% decrease compared with the second quarter of 2026 and an 18% decrease compared with the third quarter of 2025.
The reduction in operating cash usage reflects an important financial development as HeartBeam continues to prioritize its resources toward its heart attack assessment program and related clinical and regulatory activities.
As the company advances toward its planned U.S. pivotal study, financial resources will remain important for supporting clinical operations, regulatory engagement, product development, and the generation of additional clinical evidence.
HeartBeam’s decision to concentrate the majority of its resources on myocardial infarction assessment reflects its intention to focus spending on the opportunity it believes offers the greatest potential for long-term growth.
Management Highlights Strategic and Clinical Progress
Commenting on the company’s third-quarter performance and recent developments, Richard Ferrari, Executive Chairman of HeartBeam, described the period as a decisive turning point for the organization.
Ferrari noted that the company had committed most of its resources to heart attack assessment and had subsequently achieved several important milestones within a relatively short period.
He highlighted the FDA Breakthrough Device Designation, acceptance into the FDA’s TAP program, and alignment with the agency on a 510(k) submission pathway as significant developments supporting the company’s regulatory strategy.
He also emphasized the completion of HEADSTART-ACS enrollment ahead of schedule and the presentation of positive ALIGN-ACS pilot study findings at TCT 2026.
According to Ferrari, the higher specificity demonstrated by the HeartBeam System compared with the standard 12-lead ECG represents an encouraging result. He also highlighted the company’s clinical experience involving more than 600 patients across its heart attack assessment studies.
Ferrari stated that the company remains focused on beginning its U.S. pivotal study in the first quarter of 2027 and noted that the planned study will not require the development of new hardware.
Branislav Vajdic, Ph.D., Founder and President of HeartBeam, emphasized the challenges faced by individuals who experience chest pain at home and lack immediate access to reliable cardiac assessment.
He explained that uncertainty about whether chest pain represents a heart attack can contribute to delays in seeking medical attention, potentially affecting patient outcomes.
Vajdic said the company’s objective is to shorten the time between the initial appearance of symptoms and the decision to seek medical care by providing patients and physicians with clinically meaningful cardiac information when timely decisions are essential.
He added that HeartBeam believes its technology could help address this gap for millions of people who face an elevated risk of cardiovascular events.
HeartBeam’s third-quarter 2026 update reflects a period of strategic repositioning, regulatory progress, and clinical development for its cardiac technology platform.
The company’s decision to prioritize heart attack assessment has been followed by several milestones, including FDA Breakthrough Device Designation, TAP program acceptance, regulatory pathway alignment, and the completion of enrollment in its largest heart attack assessment study.
The ALIGN-ACS findings have provided initial clinical evidence supporting further investigation of the HeartBeam System, while HEADSTART-ACS has expanded the company’s clinical experience to more than 600 patients when combined with ALIGN-ACS.
Looking forward, the immediate priority is to finalize the design of the U.S. pivotal study during the fourth quarter of 2026 and begin enrollment in the first quarter of 2027. The study is expected to play a central role in supporting a future regulatory submission seeking to expand the HeartBeam System’s indication to heart attack assessment.
With an estimated $15 billion opportunity in myocardial infarction assessment and a broader cardiac platform market estimated at more than $40 billion, HeartBeam is positioning its technology for potential applications beyond arrhythmia monitoring.
The company’s progress will depend on the results of additional clinical studies, regulatory review, and its ability to demonstrate the technology’s clinical value in real-world settings. Nevertheless, its recent operational and regulatory achievements mark important steps toward its goal of making cardiac assessment more accessible and supporting earlier decision-making when heart attack symptoms occur.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company has developed the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence.
Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and its 12-lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.1 The technology is currently being studied for heart attack assessment and is considered investigational in that indication. The Company holds over 25 issued patents worldwide related to technology enablement. For additional information, visit HeartBeam.com.