HeartBeam Completes Patient Enrollment Ahead of Schedule in ALIGN-ACS Pilot Study for Heart Attack Detection
HeartBeam, Inc., a medical technology company focused on advancing cardiovascular diagnostics through innovative electrocardiogram (ECG) technology, has announced the successful completion of patient enrollment in its ALIGN-ACS pilot study. The milestone was achieved earlier than anticipated, with enrollment finalized ahead of the company’s previously projected timeline of the third quarter of 2026.
The ALIGN-ACS study is evaluating the ability of the HeartBeam System to detect acute coronary syndromes, including heart attacks, using the company’s proprietary three-dimensional ECG technology. By reaching full enrollment ahead of schedule, HeartBeam has moved one step closer to generating clinical evidence that could support future regulatory submissions and expand the capabilities of its platform beyond arrhythmia assessment.
The company believes the study represents an important milestone in its broader strategy to transform how cardiac emergencies are identified by enabling patients to capture clinical-grade heart data wherever symptoms occur rather than waiting until they arrive at a hospital.
Addressing a Critical Challenge in Heart Attack Care
Heart attacks remain one of the leading causes of death in the United States and throughout the world. Despite major advances in emergency cardiovascular care, delays in recognizing symptoms and seeking medical attention continue to contribute to preventable deaths and long-term complications.
Many patients experiencing a heart attack hesitate before contacting emergency medical services because symptoms are often inconsistent or difficult to recognize. While some individuals experience the classic crushing chest pain associated with a heart attack, others may develop milder symptoms such as fatigue, nausea, dizziness, shortness of breath, discomfort in the jaw or back, or vague chest pressure. These atypical presentations frequently result in delayed treatment.
Clinical studies have shown that many patients wait more than two hours after symptom onset before seeking emergency care. Every minute of delay can increase heart muscle damage, worsen patient outcomes, increase hospitalization costs, and reduce survival rates.
HeartBeam is developing technology intended to help address this gap by enabling earlier cardiac assessment outside of traditional healthcare settings.
A New Approach to Cardiac Monitoring
The HeartBeam System is designed around the concept of providing patients with access to clinical-grade ECG recordings wherever they happen to be when symptoms develop.
Unlike traditional electrocardiograms performed in hospitals or clinics using a standard 12-lead ECG system, HeartBeam’s technology captures cardiac electrical signals using its proprietary three-dimensional vector-based ECG platform.
The system is intended to allow patients to record heart activity immediately after symptoms begin and transmit those data for clinical evaluation.
The company’s long-term objective is to reduce the time between symptom onset and medical evaluation, commonly referred to as “symptom-to-door” time, by allowing physicians to receive meaningful diagnostic information before patients arrive at emergency departments.
Such an approach could potentially improve decision-making, accelerate treatment, and reduce unnecessary delays for patients experiencing cardiac emergencies.
Enrollment Completed Earlier Than Expected
HeartBeam confirmed that patient recruitment for the ALIGN-ACS pilot study has now been completed ahead of schedule.
Originally expected to conclude during the third quarter of 2026, enrollment was finalized earlier, reflecting efficient execution by the company’s clinical operations team and participating research sites.
Early completion of enrollment is an important operational achievement because it allows the company to begin data analysis sooner and maintain momentum toward the next stages of clinical development.
According to HeartBeam leadership, this accomplishment demonstrates both the strength of the study design and the effectiveness of the company’s execution strategy.
Leadership Highlights Operational Progress
Branislav Vajdic, Ph.D., Founder and President of HeartBeam, emphasized the significance of the enrollment milestone for the company’s broader development plans.
He noted that completing enrollment ahead of schedule reflects the operational discipline established throughout the study and positions the company well as it prepares for future pivotal clinical trials.
Dr. Vajdic also indicated that the forthcoming study data are expected to play an important role in discussions with the U.S. Food and Drug Administration (FDA).
The company is evaluating whether the successful completion of the pilot study and the resulting clinical evidence could support a more accelerated regulatory pathway toward expanding the HeartBeam System’s indications to include heart attack detection.
HeartBeam expects to release complete study findings later this year and plans to continue advancing the program with the same disciplined approach demonstrated during enrollment.
Details of the ALIGN-ACS Pilot Study
The ALIGN-ACS pilot study enrolled a total of 120 patients who presented to emergency departments with chest pain suggestive of possible acute coronary syndrome.
Enrollment was conducted across two clinical research sites located in Belgrade, Serbia.
Each participant underwent evaluation using both the conventional hospital standard 12-lead ECG and the HeartBeam System.
Investigators then compared physician assessments generated from both ECG approaches against an independently adjudicated clinical-data-based gold standard.
This study design allows researchers to evaluate how effectively the HeartBeam System identifies patients experiencing acute coronary syndrome compared with established diagnostic methods currently used in clinical practice.
Because acute coronary syndrome includes several serious cardiovascular emergencies, including myocardial infarction, accurate and timely detection remains critically important.
Data Analysis Underway
With enrollment now complete, HeartBeam has transitioned into the data analysis phase of the study.
Researchers are currently reviewing the collected ECG recordings alongside independently adjudicated clinical outcomes to determine the diagnostic performance of the HeartBeam System.
The company plans to present the complete study results at a major cardiology conference in the coming months, where clinicians and researchers will have an opportunity to evaluate the findings.
These results are expected to provide important insights into the feasibility and clinical utility of HeartBeam’s proprietary technology for identifying heart attacks outside traditional healthcare environments.
Supporting Future FDA Discussions
The ALIGN-ACS pilot study represents an important precursor to a larger pivotal clinical trial planned for the United States.
HeartBeam intends to use information generated during the pilot study to refine the design of its future pivotal program.
The company expects that discussions with the FDA will incorporate not only findings from ALIGN-ACS but also evidence from previous proof-of-concept research.
Among those earlier studies is research recently published in JACC: Advances, which provided additional validation of the company’s three-dimensional ECG technology.
Combining evidence from multiple clinical investigations will help guide the design, scope, and endpoints of the planned pivotal trial.
Ultimately, the company hopes these data will support a future regulatory submission seeking to expand the HeartBeam System’s approved indications beyond arrhythmia assessment to include heart attack detection.
Expanding the Capabilities of the HeartBeam Platform
HeartBeam’s current strategy extends beyond a single diagnostic application.
The company envisions building a comprehensive remote cardiac monitoring platform capable of providing actionable cardiovascular insights across multiple clinical scenarios.
Adding heart attack detection would significantly broaden the platform’s potential utility and increase its value for patients at elevated cardiovascular risk.
Earlier recognition of acute coronary syndrome could allow physicians to initiate treatment more rapidly while potentially reducing unnecessary emergency department visits among patients who are not experiencing a heart attack.
Such capabilities align with broader trends toward decentralized healthcare, remote monitoring, and digital diagnostics that enable clinical decision-making outside hospitals and clinics.
A Vision for Earlier Cardiac Intervention
The completion of patient enrollment in the ALIGN-ACS pilot study marks another important milestone in HeartBeam’s mission to modernize cardiac care through innovative technology.
By enabling patients to capture clinical-grade ECG recordings wherever symptoms begin, the company hopes to bridge one of the most significant gaps in cardiovascular medicine—the time between symptom onset and definitive diagnosis.
As data analysis progresses and preparations begin for a U.S. pivotal study, HeartBeam continues working toward its long-term objective of making advanced cardiac diagnostics more accessible to patients outside traditional healthcare settings.
If future studies confirm the technology’s effectiveness and regulatory approvals are obtained, the HeartBeam System could represent an important advancement in the early detection of heart attacks, helping clinicians make faster, more informed decisions while improving outcomes for patients facing one of the world’s leading causes of death.
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 the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025**. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com.
