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Heartbeam (BEAT) investor relations material
Heartbeam Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
Achieved FDA 510(k) clearance for a portable, cable-free ECG system in December 2024, with 12-lead synthesis software clearance expected by end of 2025; pivotal study showed 93.4% diagnostic agreement with standard ECGs.
Commercial readiness efforts include hardware/software enhancements, infrastructure buildout, and engagement with concierge and preventive cardiology practices in Florida and Southern California.
Early access and beta programs, plus strategic collaborations (e.g., AccurKardia), have informed product improvements and business model validation.
Strong and increasing interest from industry partners and strategic players as regulatory clearance and commercialization approach.
Expanded intellectual property portfolio to 21 issued patents worldwide and received multiple industry recognitions, including Innovation in Remote Cardiac Diagnostics.
Financial highlights
Net cash used in operating activities was $3.4M for Q2 2025, a 23% decrease from the previous quarter; cash and short-term investments totaled $5.1M at June 30, 2025.
Baseline recurring expenditure was $3.1M, 11% lower than the historic baseline; investments in commercial readiness and manufacturing totaled ~$0.3M.
Net loss for Q2 2025 was $5.0M, unchanged from Q2 2024; operating expenses for Q2 2025 were $5.0M, slightly down year-over-year.
General and administrative expenses decreased, while R&D expenses increased year-over-year for Q2 2025.
No material commercial revenue expected in 2025; continued negative cash flow from operations.
Outlook and guidance
FDA clearance for 12-lead ECG synthesis software remains on track for Q4 2025, with commercial launch to begin immediately after clearance.
Additional FDA submission for arrhythmia assessment algorithm and MI pilot study enrollment expected in Q4.
Management expects existing liquidity to be insufficient for the next twelve months, raising substantial doubt about going concern status; plans to raise additional capital.
Ongoing focus on capital efficiency, disciplined spending, and minimizing shareholder dilution while funding key milestones.
Commercial readiness plans include cardiology reader service and logistics infrastructure.
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