HeartBeam stock soars on FDA breakthrough designation

Investing.com -- Heartbeam Inc (NASDAQ: BEAT) shares surged as much as 90% Monday after the company announced the U.S. Food and Drug Administration granted Breakthrough Device Designation for its at-home heart attack assessment tool.

The designation recognizes the potential of HeartBeam's 3D ECG technology to help physicians evaluate signs of a possible heart attack when symptoms start, wherever the patient may be. The FDA granted the designation within 30 days of HeartBeam's request, ahead of the agency's 60-day statutory review period.

The Breakthrough Devices Program provides HeartBeam with prioritized FDA review and interaction throughout development, including collaboration on the clinical and regulatory path toward potential clearance. The designation also serves as a prerequisite for certain expedited Medicare coverage pathways.

HeartBeam is developing its heart attack assessment capability on the same 3D ECG platform behind its FDA-cleared arrhythmia product and does not currently anticipate the need for new hardware development. The company estimates the heart attack market opportunity at approximately $15 billion within a broader cardiac platform opportunity of more than $40 billion.

More than 20 million U.S. adults are at elevated risk of a heart attack, yet the standard 12-lead ECG used to evaluate suspected heart attacks is largely confined to hospitals and clinics.

The Breakthrough Device Designation was supported by proof-of-concept data presented at the 2025 American Heart Association Scientific Sessions and findings from the 134-patient ALIGN-ACS pilot study. HeartBeam expects to seek FDA alignment on the design of a multicenter pivotal study in the coming months and anticipates beginning patient enrollment shortly thereafter.

The company also expects to provide updates in the coming weeks on the ALIGN-ACS data presentation at the TCT conference and the HEADSTART-ACS study.

Original Article

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