HeartBeam Completes Enrollment in 486-Patient HEADSTART-ACS Study Ahead of Schedule to Advance 3D ECG Heart Attack Detection Technology
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through advanced cardiac insights, has announced the early completion of patient enrollment in its HEADSTART-ACS clinical study at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia. The study enrolled 486 patients, with data analysis currently underway and results expected to be presented at a cardiology conference in 2027.
The HEADSTART-ACS study is designed to evaluate the diagnostic accuracy of the HeartBeam System in detecting acute coronary syndrome (ACS), a group of conditions that includes heart attacks and other serious medical emergencies associated with reduced blood flow to the heart. The study focuses on patients presenting to the emergency department with chest pain, comparing the results of a conventional 12-lead electrocardiogram (ECG) with those obtained using HeartBeam’s three-dimensional (3D) ECG technology.
The completion of enrollment represents an important milestone in the company’s clinical development program as it prepares for a planned pivotal study in the United States in the first quarter of 2027. Together with the 132-patient ALIGN-ACS pilot study, for which results are scheduled to be presented at TCT 2026, HEADSTART-ACS brings total enrollment across HeartBeam’s heart attack detection studies to more than 600 patients.
The company expects the findings from these studies to contribute to the clinical evaluation of its technology and support further development of cardiac assessment solutions designed for use beyond traditional hospital environments. However, the HeartBeam System is not currently cleared for heart attack detection, and its use in both HEADSTART-ACS and ALIGN-ACS remains investigational.
HEADSTART-ACS Study Evaluates 3D ECG Technology for Acute Coronary Syndrome
HEADSTART-ACS is being conducted at the National Cardiovascular Center Harapan Kita, a major cardiovascular institution in Jakarta, Indonesia. The study enrolled 486 patients who presented to the emergency department with chest pain, a symptom that can indicate a range of conditions, including acute coronary syndrome.
ACS requires timely clinical assessment because delays in identifying and treating a heart attack can increase the risk of heart muscle damage and other serious complications. Conventional diagnostic evaluation frequently includes a 12-lead ECG, clinical examination, laboratory testing, and other assessments as appropriate.
The HEADSTART-ACS study is designed to compare the diagnostic performance of the HeartBeam System with that of a standard 12-lead ECG. Patients undergo evaluation using both technologies, and the findings from each modality will be compared with the patient’s final diagnosis at hospital discharge.
This approach is intended to assess how accurately the HeartBeam System identifies ACS in the studied patient population. The final analysis will provide additional evidence regarding the technology’s diagnostic performance in an emergency department setting.
With enrollment now complete, HeartBeam has moved into the data analysis phase. The company anticipates presenting the results at a cardiology conference in 2027. The findings may help inform subsequent clinical development and the planned U.S. pivotal study.
The completion of enrollment ahead of schedule also reflects the participation of the clinical team and study partners at Harapan Kita. The study provides HeartBeam with additional clinical experience in evaluating its technology among patients presenting with symptoms that require prompt cardiovascular assessment.
HeartBeam System Designed to Provide Three-Dimensional Cardiac Electrical Information
HeartBeam is developing its ECG technology to provide physicians with three-dimensional information about the heart’s electrical activity, offering an approach intended to deliver clinical-grade ECG information outside conventional hospital settings.
Traditional 12-lead ECG systems use multiple electrodes placed at specific positions on a patient’s body to record the heart’s electrical activity from different perspectives. The resulting information helps healthcare professionals evaluate cardiac rhythm, electrical conduction, and patterns that may be associated with ischemia or myocardial infarction.
HeartBeam’s system is designed to capture electrical information from three dimensions and provide information comparable in concept to that obtained from a traditional 12-lead ECG. Unlike smartwatches and many other consumer wearable devices that primarily record limited ECG information, HeartBeam is developing its technology for clinical cardiac assessment.
The company’s device is approximately the size of a credit card and is designed to operate without cables or the need for a trained technician to conduct the recording. Its intended portability could support cardiac assessment in settings where conventional ECG equipment and trained personnel may not be readily available.
The technology is being developed with the goal of extending access to cardiac assessment beyond hospitals and specialist facilities. Potential applications could include community healthcare centers and other locations where patients experiencing chest discomfort or other cardiac symptoms may benefit from an initial ECG assessment.
Nevertheless, the potential clinical utility of the system depends on the results of ongoing studies and applicable regulatory authorization. HeartBeam has stated that the technology is not currently cleared for heart attack detection, and its performance for this purpose remains under investigation.
Clinical Leadership Highlights the Importance of Timely Heart Attack Assessment
Dr. Iwan Dakota, an internationally recognized interventional cardiologist and Director of the National Cardiovascular Center Harapan Kita, emphasized the importance of rapid diagnosis and medical intervention in acute myocardial infarction.
Dakota stated that HeartBeam’s technology has the potential to save lives, noting that the time between the onset of a heart attack and medical intervention is an important determinant of patient survival. He also welcomed the completion of the study at Harapan Kita and expressed interest in the forthcoming results.
His comments highlight a central challenge in cardiovascular care: patients experiencing symptoms of a heart attack may not always have immediate access to appropriate diagnostic equipment or specialist medical services.
Early assessment can help clinicians identify patients who require urgent evaluation and treatment. However, a diagnostic device intended to support this process must demonstrate adequate accuracy and reliability in the relevant patient population before it can be adopted for a specific clinical purpose.
The HEADSTART-ACS study is intended to generate evidence addressing the diagnostic performance of HeartBeam’s 3D ECG technology in patients presenting with chest pain. The comparison with conventional 12-lead ECG findings and final discharge diagnoses will be important in determining how the investigational system performs within the study setting.
The planned presentation of the results in 2027 is expected to provide further information about the study’s findings and their implications for the company’s clinical development program.
More Than 600 Patients Enrolled Across HeartBeam’s Heart Attack Detection Studies
The completion of HEADSTART-ACS builds on HeartBeam’s broader clinical research program. The company has also conducted the 132-patient ALIGN-ACS pilot study, with results scheduled for presentation at TCT 2026.
When combined, the two studies represent more than 600 patient enrollments across HeartBeam’s heart attack detection research.
The growing clinical dataset is intended to support the company’s efforts to evaluate its technology before beginning a planned pivotal study in the United States during the first quarter of 2027.
Pivotal studies generally play an important role in medical device development because they are designed to generate clinical evidence addressing questions relevant to regulatory review. The precise design, endpoints, patient population, and regulatory requirements of HeartBeam’s planned U.S. study will be important considerations as the program advances.
The company views the experience gained through HEADSTART-ACS and ALIGN-ACS as a foundation for further development of its heart attack detection technology. Data from multiple studies may help researchers examine the system’s performance across different clinical settings and patient populations, although results from one study cannot automatically be generalized to all healthcare environments.
The planned U.S. pivotal study represents the next anticipated step in the company’s development program. Its initiation remains a future milestone, and the system’s intended use for heart attack detection remains investigational pending applicable regulatory clearance.
Indonesia Offers an Opportunity to Address Gaps in Cardiac Assessment
Indonesia represents a strategically important market for HeartBeam because of the country’s geographic characteristics and the challenges associated with delivering healthcare services across its many islands.
With a population of approximately 288 million people distributed across thousands of inhabited islands, the country faces logistical challenges in providing consistent access to medical infrastructure. These challenges can be particularly significant when patients need time-sensitive cardiovascular assessment.
Conventional 12-lead ECG testing generally requires suitable equipment and trained clinical personnel to perform the recording. Appropriate interpretation and follow-up may also depend on access to qualified healthcare professionals and referral pathways. These requirements can limit the availability of ECG assessment in geographically dispersed communities.
Branislav Vajdic, Ph.D., Founder and President of HeartBeam, highlighted Indonesia as an example of a healthcare environment where access to cardiac assessment outside hospitals could be particularly valuable.
Vajdic explained that many patients across Indonesia may be unable to access a conventional 12-lead ECG readily when symptoms begin. He attributed the early completion of HEADSTART-ACS enrollment to the clinical need and the commitment of the company’s partners at Harapan Kita.
He also noted that the study’s data will contribute to advancing HeartBeam’s heart attack detection program globally.
The company’s interest in Indonesia extends beyond the completion of the clinical study. HeartBeam and Indonesia’s Ministry of Health share a vision of potentially deploying the technology across community health centers throughout the country.
Under this potential approach, the HeartBeam System could be evaluated for use in assessing patients who present with chest pain and other cardiac symptoms at community-level healthcare facilities. Such assessments could potentially help healthcare professionals identify patients who require more urgent evaluation at advanced medical centers.
Any future implementation would depend on clinical evidence, applicable regulatory requirements, healthcare system integration, and decisions by relevant authorities and providers. The proposed deployment remains a potential application rather than an established nationwide program.
Harapan Kita’s Role in the Potential Healthcare Deployment Model
The National Cardiovascular Center Harapan Kita has particular relevance to HeartBeam’s research and potential future deployment plans because of its role within Indonesia’s cardiovascular care infrastructure.
According to the company, Harapan Kita oversees government hospitals across the islands and manages escalation of care from community and tertiary facilities to advanced centers equipped to provide interventional treatment.
This structure could be important in a healthcare model designed to connect initial cardiac assessment with appropriate follow-up care. If validated and authorized for the intended use, portable ECG technology could potentially support the initial evaluation of patients at facilities that do not have immediate access to conventional ECG infrastructure.
However, identifying patients who may have ACS is only one part of the care pathway. Patients with suspected heart attacks require timely clinical evaluation, appropriate confirmatory testing, and access to emergency treatment when indicated. A portable device would need to function within a broader system that supports referral, transport, interpretation, and definitive care.
For HeartBeam, the HEADSTART-ACS study offers an opportunity to evaluate its technology in a clinical environment while working with a major cardiovascular institution in a country where geographic barriers can affect access to healthcare.
Outlook for HeartBeam’s Clinical Development Program
The early completion of enrollment in HEADSTART-ACS marks a significant step in HeartBeam’s effort to develop portable ECG technology for cardiac assessment beyond traditional hospital settings.
The 486-patient study is designed to evaluate the diagnostic accuracy of the HeartBeam System for ACS by comparing its 3D ECG findings with standard 12-lead ECG results and patients’ final discharge diagnoses. Data analysis is underway, and results are expected at a cardiology conference in 2027.
Together with the 132-patient ALIGN-ACS pilot study, HEADSTART-ACS brings total enrollment across the company’s heart attack detection studies to more than 600 patients. These studies provide a clinical foundation ahead of the planned U.S. pivotal study in the first quarter of 2027.
The company’s longer-term vision includes expanding access to cardiac assessment in communities where conventional ECG equipment and trained personnel may be difficult to access. Indonesia’s geographic landscape provides a relevant setting in which to examine this potential, while the partnership with Harapan Kita offers access to a clinical environment experienced in cardiovascular care.
The upcoming results will be important in determining how the investigational technology performs and what additional evidence may be needed to support future development. Until the necessary evidence and regulatory clearances are obtained, the HeartBeam System is not cleared for heart attack detection.
By completing enrollment ahead of schedule, HeartBeam has reached an important clinical development milestone as it continues evaluating the potential role of three-dimensional ECG technology in improving access to cardiovascular assessment.
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 20251. The Company holds over 25 issued patents related to technology enablement. For additional information, visit HeartBeam.com.