HeartBeam (NASDAQ: BEAT) Launches Pilot Study for On-Demand 12-Lead ECG Patch in Coronary Artery Disease Patients

At a glance

Company: HeartBeam, Inc.
Ticker: NASDAQ: BEAT
Location: Belgrade, Serbia

Key figures

Approximate study enrollment: approximately 50 patients
Patch-based monitoring market described by the company: approximately $2 billion

Products and programs

On-demand 12-lead ECG patch
12-lead ECG synthesis software
3D ECG technology

HeartBeam (NASDAQ: BEAT) announced the initiation of a pilot study evaluating its investigational on-demand 12-lead ECG patch in approximately 50 patients with suspected coronary artery disease at two hospitals in Belgrade, Serbia. The study will compare synthesized 12-lead ECG readings generated by the company’s patch immediately following exercise stress testing against standard 12-lead ECGs, supporting HeartBeam’s regulatory strategy for a device designed to expand ambulatory cardiac monitoring beyond rhythm assessment into ischemia detection within an established approximately $2 billion patch-based monitoring market.

To view the full press release, visit https://ibn.fm/x7016

About HeartBeam, Inc.

HeartBeam, Inc. is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating 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 in December 2025(1) . The Company holds over 20 issued patents related to technology enablement.

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Questions around this news

What is HeartBeam evaluating in the pilot study?
The study is assessing an investigational on-demand ECG patch in people with suspected coronary artery disease. It will compare the patch’s synthesized 12-lead ECG readings, taken immediately after exercise stress testing, with standard 12-lead ECG readings. The release says the pilot is intended to support the company’s regulatory strategy.
Where will the study take place, and who will participate?
The pilot is planned at two hospitals in Belgrade, Serbia, and is expected to involve approximately 50 patients with suspected coronary artery disease. The release does not identify the hospitals or provide further details about eligibility, recruitment, or the study timeline.
What is a synthesized 12-lead ECG?
A 12-lead ECG presents electrical activity of the heart from multiple viewing angles, helping clinicians assess its electrical patterns. A synthesized version uses signals collected from a smaller set of measurement directions and processes them to produce a 12-lead representation. Its clinical use depends on the device and the evidence supporting it.

SEC filings

Earlier from HeartBeam, Inc.

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