Company Overview & Strategy - HeartBeam aims to shift cardiac care from hospitals to home, similar to trends seen with glucose, blood pressure, and oxygen monitors[15, 16] - The company's synthesized 12-Lead ECG system, combined with on-demand cardiologist interpretation, is the foundation for a new cardiac care model[21] - HeartBeam is building an ecosystem around its core technology to deepen patient engagement and provide actionable insights for physicians[21, 23] - The company's near-term commercial strategy focuses on creating a new category, market entry through pilot programs, a focused commercial model, and patient retention[30] Regulatory & Clinical Milestones - HeartBeam received foundational FDA clearance for its system for arrhythmia assessment in December 2024[9, 13, 25] - FDA 510(k) clearance for the 12-Lead ECG Synthesis Software for arrhythmia assessment is anticipated in Q4 2025[13, 25, 34] - A pivotal clinical study (VALID-ECG) showed 93.4% overall diagnostic agreement for arrhythmia assessment[25] - New data presented at AHA Scientific Sessions in November 2025 supports HeartBeam's potential for early heart attack detection[27] Financial Performance (Q3 2025) - Total operating expenses were $5290 thousand[31] - Net loss was $5255 thousand, with an Earnings per Share (EPS) of $(0.15)[31] - Net cash used in operating activities was $3160 thousand, an 8% decrease quarter-over-quarter[31, 33] - Cash and cash equivalents and short-term investments totaled $1856 thousand as of September 30, 2025[31]