Heartbeam stock is a buy, this analyst says

In a Dec. 10 note, Roth Capital Markets analyst Kyle Bauser reiterated his “Buy” rating and $4.00 price target on HeartBeam (HeartBeam Stock Quote, Chart, News, Analysts, Financials NASDAQ:BEAT) after the company received FDA 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software; an approval secured through a successful appeal overturning a prior Not Substantially Equivalent (NSE) determination.

Santa Clara–based HeartBeam is developing a cable-free, credit-card-sized ECG recorder that captures 3D cardiac signals and synthesizes them into a diagnostic-quality 12-lead ECG. The platform’s foundational hardware system received FDA clearance in December 2024; the newly cleared software converts the 3-lead recordings “into a visual 12-lead ECG representation similar to that of a standard diagnostic 12-lead ECG,” indicated for manual assessment of sinus rhythms and arrhythmias.

As Bauser noted, the software “does not conduct cardiac analysis and is not intended to replace the standard 12-lead ECG.”

With this approval, HeartBeam plans a limited U.S. commercial launch in 1Q26, initially targeting concierge and preventive cardiology practices that “have proactively signalled strong interest.” Bauser said the controlled rollout will allow the company to establish early reference sites and begin generating real-world evidence ahead of broader geographic expansion.

Management outlined several parallel growth initiatives, including the pursuit of a heart-attack detection indication, the advancement of an on-demand 12-lead extended-wear ECG patch (a prototype is already in place), and the development of a longitudinal 12-lead ECG dataset to support future AI-driven screening and prediction algorithms.

Bauser called the extended-wear patch “a multi-billion-dollar reimbursement opportunity” if successfully commercialized.

He left his estimates unchanged, noting the successful appeal did not materially delay regulatory timing and that commercial plans remain aligned with the original 1Q26 target.

Bauser expects HeartBeam to post negative Adjusted EBITDA of $(21.2)-million on no revenue in 2025, followed by $(26.5)-million on $1.6-million of revenue in 2026.

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