HeartBeam, Inc. Q1 FY2025 earnings call

• HeartBeam is developing a cable-free ECG that synthesizes a 12-lead ECG. Received foundational FDA 510(k) clearance in December for the system, and submitted a second 510(k) in January for the 12-lead synthesis software, expected to be cleared by end of 2025.
• VALID-ECG study results presented at Heart Rhythm Society met endpoints, forming the basis for FDA submission of the 12-lead synthesis software. Physicians' classification agreement between standard and HeartBeam 12-lead ECGs was 93.4%.
• Engaged with FDA on expanding indication to ischemia, expecting to initiate pilot clinical study later in 2025.
• Strategic collaboration with AccurKardia to add its ECG algorithm to HeartBeam System, leveraging AccurKardia's FDA-cleared arrhythmia classification algorithm.
• Commercial readiness efforts include early access program testing with concierge accounts, building infrastructure (customer support, inventory/logistics), and selecting a contract manufacturer.
• Intellectual property: 20 issued U.S. patents, expanded Scientific Advisory Board with Dr. Vivek Reddy.

No specific product segment financial performance data provided in the transcript, as it does not break down revenue by product segments in terms of absolute values and contribution percentages.

• Anticipate FDA clearance for the 12-lead synthesis software by the end of 2025.
• Plan to start a pilot clinical study on the use of the system in patients with ischemia later in 2025.
• Progressing with commercial readiness efforts such as early access program, infrastructure build-out, and contract manufacturing in preparation for commercial launch.

• Potential impact of FDA staffing changes or delays, though no specific disruptions reported yet.
• Dependence on successful FDA clearance and smooth commercialization.
• Supply chain risks related to component sourcing, but efforts in place to mitigate with U.S.-based contract manufacturing and monitoring of component lead times.

Q: Bill Sutherland asked about learnings from the early access program.

A: Rob Eno mentioned real-world patient use, training, feedback on onboarding and features, and building out supporting systems like customer service.

Q: Bill Sutherland asked about pricing.

A: Rob Eno and Tim Cruickshank discussed potential $50-$100 per month recurring revenue, with tiered pricing explored.

Q: Leo Carpio asked about FDA process and disruption.

A: Rob Eno stated no disruption, ongoing productive discussions with FDA in substantive review phase, on track for end-of-year clearance.

Q: Leo Carpio asked about AccurKardia partnership.

A: Rob Eno explained the partnership bolsters competitive position by providing automated rhythm assessment for routine recordings, completing the product pipeline.

Q: Larry Holub asked about pivotal study takeaways.

A: Rob Eno explained the study showed similarity to standard 12-lead ECG, supporting FDA submission.

Q: Larry Holub asked about manufacturing capabilities and tariffs.

A: Tim Cruickshank talked about U.S.-based contract manufacturer, low China component sourcing, and mitigation strategies for tariffs and supply chain issues.