HeartBeam, Inc. Q3 FY2024 earnings call

• HeartBeam has developed cable-free 12-lead ECG technology using vector-based approach and AI for personalized insights, targeting over $100 billion U.S. addressable market. • FDA 510(k) submission is progressing, with responses to FDA questions and confidence in near-term clearance. • Management team updated: Rob Eno as CEO, Branislav Vajdic focusing on R&D, Tim Cruickshank as CFO. • Significant clinical evidence: Over 9 peer-reviewed publications, 500+ patients enrolled, VALID-ECG study completed enrollment, AHA presentation of pilot study results upcoming. • Milestones: Anticipate foundational FDA clearance, second 510(k) submission for 12-lead synthesis, early access program post-initial clearance, limited commercial launch, AI efforts on arrhythmia classification, and interactions with FDA for ischemic events indication.

No detailed product segment financial performance provided in the transcript.

• Expect foundational FDA clearance in near term. • Plan to submit second 510(k) application for 12-lead synthesis soon after initial clearance, estimating second clearance next year. • Start early access program post-initial 510(k) clearance, followed by limited commercial launch. • Plan RAISE-ECG study for AI arrhythmia classification, and interact with FDA for expanding clinical indication to ischemic events. • Anticipate data releases in 2025.

• Uncertainties around FDA clearance timelines. • Potential delays in regulatory approvals. • Cash burn management challenges. • Market acceptance of the technology as a new standard of care.

Q: Can you provide more detail on the timing of the FDA clearance? And what are the outstanding items?

A: FDA is engaged, confident in near-term clearance, preparing for early access program after initial clearance.

Q: Given your cash burn, what are your plans for raising capital?

A: Managing cash burn closely, strong support from existing shareholders, opportunistic financing to manage dilution.

Q: Can you provide more context on the timing and the reason for the change in CEO from Branislav to Rob?

A: Transition planned long, Branislav as visionary, Rob with commercial background, Branislav to lead technical efforts.

Q: Can you provide an update on how the timing and results of the VALID-ECG study?

A: VALID-ECG study completed enrollment, data basis for second FDA submission, AHA pilot study results upcoming.

Q: If everything goes right with the FDA, what could 2025 revenues look like for HeartBeam?

A: Massive opportunity, no significant revenue in 2025 anticipated, focus on early access program and gathering feedback.