HeartBeam, Inc. Q2 FY2025 earnings call

1. Regulatory Status: Received foundational FDA 510(k) clearance in Dec 2024 for the HeartBeam system; submitted second 510(k) in Jan 2025 for 12-lead synthesis software, expected cleared by end 2025. Engaging with FDA to expand indication to ischemia. 2. Ecosystem Building: Automated arrhythmia assessments with AccurKardia, integration with wearables, AI wellness features, community features, and long-term ECG trending. 3. Commercial Readiness: Finalizing cardiology reader service, infrastructure for launch, next-gen hardware developed; identified pilot geographies (Florida and Southern California); interest from industry partners. 4. Awards and Patents: Abstract on AI algorithm accepted, additional patent issued; won Innovation in Remote Cardiac Diagnostics and finalist for Octane High-Tech Awards.

No detailed product segment financial performance provided in the transcript.

1. FDA clearance for 12-lead synthesis software expected in Q4 2025, followed by pilot commercial launch. 2. FDA submission of AccurKardia algorithm application and start of MI pilot study enrollment in Q4. 3. Continued focus on capital efficiency, reducing cash burn, and managing dilution to minimize shareholder dilution.

1. Uncertainties related to FDA approval timelines. 2. Market acceptance and competition risks. 3. Dependence on successful commercialization and partnerships.

Q: Update on early access program and commercial strategy?

A: Beta program going well, software refined based on feedback; pilot launch in Southern California and Florida, outreach to target practices to validate pricing.

Q: Status of Chief Commercial Officer search?

A: Candidate lined up, waiting on timing closer to launch.

Q: OBBB Act impact?

A: No impact on plans.

Q: Productive discussions with FDA?

A: Positive and productive, familiar FDA team, VALID-ECG study submitted.

Q: Future funding and dilution?

A: Focus on managing dilution, cash burn reduced, flexibility in funding timing.

Q: Device and subscription pricing?

A: Working on subscription model, expected annual revenue per unit $500-$1000, refining details.

Q: Competition with iRhythm?

A: Complementary, different use case, not direct competition.

Q: Training for doctors/hospitals?

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

Q: Ecosystem, pilot timeline, wearable integration?

A: Ecosystem developing, pilot launch soon after FDA clearance, wearable integration on roadmap post-launch