HEADSTART-ACS Completes Enrollment Ahead of Schedule, the Largest Heart Attack Detection Study to Date Using HeartBeam Technology

Data analysis is underway ahead of anticipated study results in 2027 and a planned U.S. pivotal study.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• HEADSTART-ACS study conducted in collaboration with Indonesia’s National Cardiovascular Center in world’s fourth most populous country, representing strategically significant market of 288 million people
• Data analysis is underway, with results anticipated for presentation at a cardiology conference in 2027
• With the HEADSTART-ACS and ALIGN-ACS studies, HeartBeam has clinical experience with more than 600 patients in heart attack detection, ahead of its U.S. pivotal study planned for Q1 2027

SANTA CLARA, Calif.--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced that the HEADSTART-ACS study, conducted at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia, has completed enrollment ahead of schedule. The study enrolled 486 patients with data analysis underway and the results anticipated to be presented at a cardiology conference in 2027.

HEADSTART-ACS is designed to evaluate the diagnostic accuracy of the HeartBeam System in detecting acute coronary syndrome (ACS), which includes heart attack. Patients presenting to the emergency department with chest pain were evaluated with both a standard 12-lead ECG and the HeartBeam 3D ECG, and results from both modalities will be compared against each patient’s final diagnosis at discharge. HeartBeam’s 3D ECG provides physicians with three-dimensional information about the heart’s electrical activity similar to a traditional 12-lead ECG, unlike smartwatches and other wearables. The credit card-sized device requires no cables or trained technicians and is designed to deliver a clinical-grade ECG outside of traditional hospital settings, extending access to cardiac assessment wherever patients are.

Dr. Iwan Dakota, internationally recognized interventional cardiologist and Director of the National Cardiovascular Center Harapan Kita, stated, “HeartBeam’s technology has the potential to save many lives. In cases of acute myocardial infarction, time to medical intervention is a critical determinant of patient survival. We welcome and strongly support the completion of this study at our hospital and look forward to its results with great interest.”

Together with the 132-patient ALIGN-ACS pilot study, whose results will be presented at TCT 2026, HEADSTART-ACS brings total enrollment across HeartBeam’s heart attack detection studies to more than 600 patients. This body of work gives HeartBeam significant clinical experience with its heart attack detection technology ahead of the planned initiation of its pivotal study in the U.S. in the first quarter of 2027. The HeartBeam System is not currently cleared for heart attack detection and its use in the HEADSTART-ACS and ALIGN-ACS studies is investigational.

“Indonesia is a prime example of why heart attack assessment outside the hospital is a significant need,” said Branislav Vajdic, PhD, Founder and President of HeartBeam. “In a country of 288 million people spread across thousands of inhabited islands, many patients are unable to readily access a 12-lead ECG when symptoms start. Completing enrollment ahead of schedule reflects both the strong need and the dedication of our partners at Harapan Kita, and the data from this study will help advance our heart attack detection program worldwide.”

Indonesia represents a meaningful strategic opportunity for HeartBeam as the geography places significant strain on traditional ECG infrastructure. Standard 12-lead ECGs require trained clinical staff to conduct the test and physicians to interpret, limiting access to cardiac care for the country’s dispersed communities. HeartBeam and Indonesia’s Ministry of Health share a common vision to address this gap, potentially deploying the HeartBeam System across community health centers throughout the islands to assess patients presenting with chest pain and other cardiac conditions, and to identify those who need immediate care. Conducting the study at the National Cardiovascular Center is especially meaningful, as it oversees government hospitals across the islands and manages escalation of care from community and tertiary centers to advanced facilities equipped for intervention.

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.

Forward-Looking Statements

All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

¹Cleared Indications for Use

The HeartBeam System with 12-Lead ECG synthesis software is FDA cleared for arrhythmia assessment. Refer to the Company’s Cleared Indications for Use and full instructions at https://www.heartbeam.com/indications for details on the intended use of its technology.

MKT-145 v0

View source version on businesswire.com: https://www.businesswire.com/news/home/20261021715503/en/

Media Contact:
media@heartbeam.com

Investor Relations Contact:
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
BEAT@mzgroup.us
www.mzgroup.us

Source: HeartBeam, Inc.

Key Terms

acute coronary syndrome medical

Acute coronary syndrome is a group of medical emergencies caused by a sudden drop in blood flow to the heart, typically presenting as a heart attack or severe, unstable chest pain. For investors it matters because changes in incidence, new treatments, devices, clinical trial results, regulatory approvals or safety concerns can quickly affect hospital costs, drug and device sales, insurer payouts and the financial outlook for companies tied to cardiovascular care—think of it like a sudden traffic jam that stops the engine and forces rerouting of resources.

acute myocardial infarction medical

Acute myocardial infarction, commonly called a heart attack, happens when blood flow to part of the heart is suddenly blocked, causing heart muscle to be damaged or die; think of it as a plumbing clog that starves part of the heart of oxygen. Investors care because such events drive demand for emergency treatment, long‑term medications, medical devices and hospital services, affect healthcare costs and reimbursement patterns, and can influence the financial outlook and regulatory scrutiny of companies in pharmaceuticals, medical devices and health services.

12-lead ecg technical

A 12-lead ECG (electrocardiogram) is a common medical test that records the heart’s electrical activity from 12 different viewpoints using sensors on the chest and limbs—like taking a multi-angle snapshot of the heart’s rhythm and signals. It matters to investors because it is a routine tool for detecting heart problems and monitoring safety in clinical trials and product use; abnormal findings can influence regulatory decisions, trial outcomes, or a healthcare company's market value.

pivotal study medical

A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.