HeartBeam, Inc. Q4 FY2024 earnings call

1. FDA Clearance and Submissions: Received foundational FDA clearance for the HeartBeam system in December 2024. Submitted a 510(k) application in January 2025 for the twelve-lead synthesis software. VALID ECG pivotal study results accepted for presentation at the Heart Rhythm Society Annual Meeting in late April 2025. 2. Clinical Studies: Results of two additional clinical studies presented at the American Heart Association meeting in November 2024, including a pilot study on arrhythmia detection and a feasibility study on acute coronary conditions. 3. Early Access Program: Commenced early access program to refine end-to-end workflow, ensure operational readiness, validate messaging, and establish an early adopter sales funnel. 4. Fundraising: Completed an $11.5 million public offering in February 2025. 5. Awards: Awarded the Diamond Pinnacle Health Care Award in medical device innovation. 6. Go-to-Market Strategy: Plan to start with direct patient pay in concierge and preventive cardiology practices, then expand to payer plans and integrated health care systems. Focus on two geographic markets for initial pilot commercialization.

No specific product segment financial performance details provided in the transcript.

1. Anticipate receiving FDA clearance for the twelve-lead synthesis software before the end of 2025. 2. Plan to initiate pilot commercialization after FDA clearance for the twelve-lead synthesis software. 3. Expect to reassign 2024 R&D spend to new milestones in 2025. 4. Prudent cash burn management with a cash balance of $12.6 million as of December 31, 2024, providing runway for near-term milestones.

1. Uncertainty in FDA approval timelines due to political or regulatory changes. 2. Competition in the ambulatory ECG space, though HeartBeam's IP-protected design is unique. 3. Dependence on successful execution of near-term milestones for commercialization.

Q: Congratulations on receiving your first FDA clearance. What went into your decision to not immediately commercialize upon clearance?

A: Initial clearance was for the system with three-lead output. Focus is on getting twelve-lead synthesis software cleared first to commercialize with the full system for better differentiation.

Q: What are your expectations for cash burn in 2025 and timing of next raise?

A: 2024 operating cash outflow of $14.5M is baseline for 2025. Prudent spend in first half, increasing for commercial readiness in second half. Capital raise provides runway for near-term milestones, with strategic capitalization planned later.

Q: Can you discuss what the pathway or road map is to get to heart attack detection?

A: Stepwise approach with FDA, starting with three-lead and twelve-lead synthesis for arrhythmia. Plan to speak with FDA soon, initiate new clinical study on heart attack detection later in 2025.

Q: Is there any competition in the same space?

A: Other ambulatory ECGs exist, but HeartBeam's cable-free, three-directional, twelve-lead synthesis with IP is unique; no direct competitors in its specific space.

Q: Are you concerned about the political changes having an effect on getting timely FDA approval?

A: Monitoring situation, but interactions with FDA review team haven't shown impact yet; confident in current track.

Q: Does your initial go-to-market plan include wearables?

A: Device isn't a wearable, but potential to combine with wearable data for enhanced insights.

Q: Are you planning to initially commercialize this technology alone or with a partner?

A: Assessing all options, planning initial pilot commercialization with own team in two markets to validate demand and playbook, then consider partnerships.

Q: When is the expected clearance time from FDA for the second clearance?

A: Estimate before end of 2025, but specific timing uncertain; good relationships with FDA and positive submission track.

Q: Can you give us more details on the early access program?

A: Focus on refining clinical workflows, operational readiness, commercial messaging, and building early adopter funnel; includes hundreds of patients.