HeartBeam, Inc. Q3 FY2024 earnings call

HeartBeam has developed core technology for cable-free 12-lead ECG using vector-based approach and AI. The company's FDA 510(k) submission is progressing with active review. The management team has evolved, with Rob Eno as CEO, Tim Cruickshank as CFO, and Lance Myers as Chief AI Officer. There's a significant body of clinical evidence with 9 peer-reviewed publications and over 500 patients enrolled. Awards received include Rising Star at Global Healthcare Conference. Key milestones include foundational FDA clearance, completion of VALID-ECG study, and plans for early access program and limited commercial launch upon 510(k) clearance.

Anticipate achieving foundational FDA clearance soon. Plan to submit second 510(k) for 12-lead synthesis after initial clearance, estimating second clearance next year. Plan early access program and limited commercial launch upon 510(k) clearance. AI efforts focus on arrhythmia classification with planned clinical study and expansion of clinical indication.

Uncertainty in FDA clearance timeline. Dependence on clinical study results and FDA feedback. Cash burn management and capital raising risks.

Q: Can you provide more detail on the timing of the FDA clearance?

A: FDA is engaged and responsive, confident in near-term clearance, but can't discuss ongoing discussions.

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

A: Managing cash burn closely, strong support from existing shareholders, focus on value-add investors.

Q: Context on CEO change from Branislav to Rob?

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

Q: Update on VALID-ECG study?

A: Completed enrollment, data basis for second FDA submission, pilot study results at AHA.

Q: 2025 revenues if FDA goes right?

A: No significant revenue in 2025, focus on early access program and feedback for commercial launch.