HeartBeam, Inc. Q2 FY2025 earnings call

• HeartBeam's system: Received foundational FDA 510(k) clearance in Dec 2024 for the system, submitted second 510(k) in Jan 2025 for 12-lead synthesis software (expected clearance by end 2025). - Ecosystem building: Includes automated arrhythmia assessments via AccurKardia integration, wearable integration, AI wellness features, community features, and long-term ECG trending. - Regulatory progress: Productive FDA discussions on 12-lead synthesis, engaging with FDA to expand indication to ischemia, signed agreement with AccurKardia. - Commercial readiness: Finalizing cardiology reader service, infrastructure for launch, industry interest; received industry recognitions. - Financials: Net cash used in operating activities $3.4M (23% decrease q/q); cash balance $5.1M; focus on capital efficiency and minimizing dilution.

N/A (HeartBeam is a pre-commercial company with no detailed product segment financials)

• FDA clearance for 12-lead synthesis software remains on track for Q4 2025, followed by pilot commercial launch. - Q4 milestones: FDA submission of AccurKardia algorithm application, start of enrollment in MI pilot study.

• Regulatory risks: Uncertainties in FDA review process for software and other submissions. - Commercialization risks: Delays in launch due to regulatory/market factors. - Cash burn risks: Need to manage cash burn to ensure adequate funding for commercialization.

Q: Update on early access program and commercial strategy?

A: Beta program going well, refining software based on feedback; pilot commercial launch in Southern California and Florida, outreach to key practices.

Q: Status of Chief Commercial Officer search?

A: Candidate lined up, timing to be finalized closer to launch.

Q: Impact of OBBB Act?

A: No impact on plans.

Q: Details on FDA discussions?

A: Positive and productive discussions, FDA familiar with technology from initial clearance, VALID-ECG study submitted.

Q: Future funding and dilution management?

A: Focus on managing dilution, $5.1M cash on hand, working to maintain clean cap table.

Q: Device pricing and subscription?

A: Working to finalize price and business model, aiming for $500-$1,000 annual range, 50% margin early days, 70+% recurring.

Q: Competition with iRhythm?

A: Complementary, different use case; HeartBeam for routine recordings and symptom monitoring, iRhythm for 14-day patches.

Q: Training for doctors/hospitals?

A: Plans for salesperson, clinical application specialist, training patients and trainers, cardiology reader service training.

Q: Ecosystem, pilot timeline, wearable integration?

A: Ecosystem developing, pilot launch soon after Q4 FDA clearance, wearable integration to prompt HeartBeam readings based on wearable parameters.