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HeartBeam, Inc. Letter to Shareholders
HeartBeam (BEAT) issued a shareholder letter outlining a strategic shift to prioritize development of its myocardial infarction (heart attack) detection program and 12‑lead ECG patch over scaling commercialization of its existing FDA‑cleared arrhythmia product.The company will redirect most financial and human resources to clinical validation, algorithm development and regulatory work aimed at a future heart attack assessment indication, citing an internally estimated $15 billion MI opportunity within a broader >$40 billion cardiac platform market. Enrollment in the 134‑patient ALIGN‑ACS pilot study has been completed, and the 500‑patient HEADSTART‑ACS trial has passed 75% enrollment, with an FDA pre‑submission for a pivotal study filed in August.HeartBeam will continue limited commercialization of its arrhythmia product and advance its 12‑lead patch toward FDA clearance, targeting a ~$2 billion market through strategic commercialization partners rather than building its own large sales infrastructure.
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