HeartBeam, Inc. Q3 FY2025 earnings call

Vision and Product Overview

• HeartBeam is developing a portable cable-free ECG to synthesize a 12-Lead ECG for home use, with on-demand cardiologist interpretation.
• Received foundational FDA 510(k) clearance in December 2024 for the HeartBeam system. Submitted second FDA 510(k) application in January 2025 for 12-Lead ECG synthesis software.
• VALID-ECG pivotal study showed 93.4% diagnostic agreement between HeartBeam's synthesized 12-Lead ECG and standard 12-Lead for arrhythmia assessment.
• Early access program (beta testing) provided feedback to enhance user experience. Signed agreement with HeartNexus for cardiology reader service.

Upcoming Milestones

• Anticipate FDA 510(k) clearance for 12-Lead ECG synthesis software by end of 2025.
• In 2026, expect to start enrollment on clinical trials for clinical and cost-effectiveness benefits.
• Preparing for commercialization, including hiring Chief Commercial Officer and initial agreements with concierge and preventive cardiology practices.

Clinical Evidence and IP

• Presentations at scientific meetings on AI arrhythmia classification and heart attack detection.
• Added 3 newly issued patents, bringing total to 24. Ranked #2 worldwide in 12-Lead ECG innovation out of 243 companies analyzed.

No detailed product segment financial performance provided in the transcript.

Forward-Looking Statements

• Anticipate FDA clearance for 12-Lead ECG synthesis software by end of 2025.
• Plan to start clinical trials on clinical and cost-effectiveness benefits in 2026.
• Prepare for commercialization including hiring and initial market entries with concierge and preventive cardiology practices.
• Expect growth in 2026 and beyond as they expand into additional regions and scale the business.

Risks Discussed

• Uncertainties regarding FDA clearance timelines and potential delays.
• Market adoption risks, including patient and practice acceptance of the new technology.
• Manufacturing and inventory management challenges, though confident in off-the-shelf components and U.S. contract manufacturer.
• Concerns about dilution and balancing capital needs to minimize impact on existing shareholders.

Q: Discussions with the FDA A: Interactions with FDA are productive, and the company anticipates FDA clearance for the 12-Lead ECG synthesis software by the end of 2025.

Q: Initial market launches A: Focus on prominent concierge and preventive cardiology practices initially, starting with 2 U.S. regions to prove the business model.

Q: Pricing model A: Plan to use a subscription offering with a 1-year upfront subscription, including device and access to cardiology reads; routine recordings have unlimited reads, while symptomatic readings use a credit and activate the reader service.

Q: Inventory and manufacturing A: Use off-the-shelf components with a U.S.-based contract manufacturer; confident in manufacturing capabilities, focusing on onboarding and workflow to ensure a smooth launch.

Q: Initial market launches TAM A: Target 2 regions (e.g., Southern California and South Florida), focusing on proving the business model with prominent accounts first.

Q: Marketing targeting A: Work with practices to support patient outreach, with plans for referral business and potential direct-to-consumer marketing as they expand.

Q: Funding plans A: Strategically balancing minimizing dilution and having proper capital to capitalize on opportunities, with optionality in funding sources.

Q: Pathway for myocardial infarction detection A: Started discussions with FDA, plan to pursue an expanded indication for myocardial infarction detection, including clinical studies to show performance compared to standard 12-Lead.

Q: HeartNexus partnership A: Working with HeartNexus for cardiology reader service, open to expanding the network to other telcardiology firms if accounts show interest.

Q: Strategic partners A: Looking for strategic partners in distribution, concierge and preventive cardiology chains, and potential co-development partners for pipeline technologies.