HeartBeam, Inc. Q1 FY2025 earnings call

• HeartBeam is developing a cable-free ECG that synthesizes a 12-lead ECG. It has foundational FDA 510(k) clearance and a second 510(k) application for 12-lead synthesis software under review by the FDA, with anticipation of clearance by end 2025.
• The VALID-ECG study met endpoints, showing high agreement (93.4% classification similarity) between synthesized 12-lead ECGs and standard 12-lead ECGs for arrhythmia assessment.
• Collaborated with AccurKardia for an arrhythmia classification algorithm, aiming to clear the joint solution. Discussions with FDA on expanding indication to ischemia and plan to initiate a pilot study later in 2025.
• Commercial readiness efforts include early access program (real-world patient onboarding and feedback), building customer support infrastructure, and selecting a contract manufacturer for scaling.
• Strengthened intellectual property with 20 issued patents worldwide. Board and scientific advisory board expanded with new appointments.

No detailed breakdown of product segment financials provided in the transcript. Financials discussed focus on cash management and operating expenses without specific product segment revenue contributions.

• Anticipate FDA clearance for the 12-lead synthesis software by the end of 2025.
• Plan to commercialize post-clearance, with early access program providing feedback on product usability.
• Pricing expected to be in the range of $50 to $100 per month on a recurring revenue basis, with potential tiered options.

• Potential delays in the FDA review process for the 12-lead synthesis software application.
• Manufacturing risks such as tariffs, component shortages, and long lead times for manufacturing components.

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

A: Rob Eno said real-world patient onboarding, feedback on features, and building supporting systems like customer service were key learnings.

Q: Bill Sutherland asked about pricing development.

A: Rob Eno stated pricing is likely $50 to $100 per month recurring, with tiered options explored. Tim Cruickshank added pricing may have optionality in bundled vs upfront.

Q: Leo Carpio asked about FDA updates and AccurKardia partnership.

A: Rob Eno said FDA process is on track with no disruption, and the AccurKardia partnership bolsters competitive position by providing automated rhythm assessment for routine recordings.

Q: Larry Holub asked about pivotal study takeaways and manufacturing.

A: Rob Eno said the pivotal study showed similarity for FDA clearance, and Tim Cruickshank discussed U.S.-based manufacturing, tariff mitigation, and component monitoring.