HeartBeam, Inc. Q2 FY2024 earnings call

• HeartBeam is developing AIMIGo, a credit card-sized cable-free cardiac monitoring device leveraging vector technology for 12-Lead ECG. It has potential for heart attack detection, complex arrhythmia identification, and monitoring chronic conditions. • 510(k) submission for AIMIGo is in substantial FDA review phase, with progress in addressing FDA questions. • Completed enrollment in VALID-ECG study (198 patients) comparing AIMIGo and 12-lead ECGs, data analysis ongoing. • AI development progress with presentations at electrophysiology conferences, working to freeze AI models. • Prepared materials for second FDA 510(k) submission on algorithms converting AIMIGo's 360-degree signals to synthesized 12-lead ECG.

No detailed product segment financial performance with absolute terms and revenue contribution % provided. General and administrative expenses for Q2 2024 were $2.2 million vs $1.8 million in Q2 2023. R&D expenses for Q2 2024 were $2.8 million vs $1.5 million in Q2 2023. Net loss for Q2 2024 was $5 million vs $3.2 million in Q2 2023. Ended the quarter with approximately $9.2 million in cash and cash equivalents.

• Anticipate limited launch of AIMIGo by end of 2024 to gather real-world feedback. • Preparing materials for second FDA 510(k) submission on algorithms related to VALID-ECG study, to be submitted soon after AIMIGo clearance. • Plan to freeze AI algorithms for clinical study to demonstrate performance.

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

A: We are under active FDA review, have resolved most questions, and are addressing remaining ones, still anticipating limited launch by end of year.

Q: Explain where you're going with the market sizes shown?

A: Progression from symptom-driven diagnosis (arrhythmia) to ischemia/heart attack detection, extended wear patch monitoring, monitoring chronic conditions, and ultimately prevention/screening with AI.

Q: What are the results of the VALID-ECG study?

A: Enrollment completed in June, data is currently being analyzed; results not available yet, but will be basis for second FDA submission.

Q: If 12-Lead ECG is being evaluated by a physician, why use AI?

A: AI will provide automated arrhythmia classification immediately after use, with ECG sent to physician for full clinical picture; AI plays role in informing patient and assisting diagnosis.

Q: Will initial AIMIGo detect heart attacks from the start?

A: Focusing on arrhythmia detection first, with plan to apply resources to enable heart attack detection once arrhythmia detection is productized.

Q: Can you speak to pursuing FDA approval for atrial flutter vs atrial fibrillation?

A: Initial indications for AIMIGo cover a range of arrhythmias including atrial flutter and fibrillation, within scope of initial clearance