HeartBeam shifts focus to heart attack detection, away from arrhythmia

HeartBeam, Inc. (NASDAQ: BEAT) issued a letter to shareholders outlining a strategic shift that prioritizes heart attack, or myocardial infarction (MI), detection over the broader commercialization of its existing FDA-cleared arrhythmia product.

The Santa Clara, California-based medical technology company said it will redirect the majority of its financial and human resources toward MI detection, citing capital efficiency as the primary reason for scaling back commercial infrastructure around its arrhythmia product. Limited commercialization of the arrhythmia product will continue to support existing customers and generate real-world data.

HeartBeam completed enrollment in its 134-patient ALIGN-ACS pilot study in under four months, with results accepted for presentation at TCT 2026. Its 500-patient HEADSTART-ACS study, supported by the Indonesian government, surpassed 75% enrollment in under three months. The company also submitted a pre-submission request to the FDA in August as part of its path toward a pivotal study and a future MI detection indication.

The company estimates the MI market opportunity at approximately $15 billion, within a broader cardiac platform opportunity it places at more than $40 billion, based on internal analysis.

A second priority involves the company's 12-lead patch, which combines continuous rhythm monitoring with on-demand 12-lead ECG synthesis. HeartBeam said it intends to advance the patch toward FDA clearance while seeking a strategic commercialization partner rather than building its own sales infrastructure. The company said it is currently in active discussions with potential partners and estimates the addressable market for the patch at approximately $2 billion. No deal has been announced.

The letter was signed by Executive Chairman Richard Ferrari and President and Founder Branislav Vajdic, PhD. The company holds more than 25 issued patents related to its 3D ECG technology, which received FDA clearance for arrhythmia assessment in December 2024, with its 12-lead ECG synthesis software receiving clearance for the same indication in December 2025.

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