HeartBeam Earnings Call Transcripts
Fiscal Year 2026
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A novel at-home 12-lead ECG platform is launching with a subscription model targeting concierge cardiology, leveraging strong physician and patient demand. The company is expanding into ambulatory monitoring and AI-driven cardiac care, supported by clinical studies and strategic partnerships.
Fiscal Year 2025
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FDA clearance for 12-lead ECG software enabled a focused commercial launch in concierge cardiology, with strong early demand and a scalable subscription model. Clinical and AI initiatives advanced, including a Mount Sinai partnership and ongoing studies, while financial discipline kept cash outflows in check.
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Q3 2025 saw continued progress toward FDA clearance for a novel at-home ECG system, with a net loss of $5.3M and cash use declining. Commercial launch is planned for early 2026, focusing on two U.S. regions and leveraging a new partnership for nationwide cardiologist coverage.
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Q2 2025 saw reduced cash burn and strong progress toward FDA clearance for the 12-lead ECG software, with commercial launch preparations advancing in key markets. Strategic partnerships, industry recognition, and a robust capital strategy position the business for growth.
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A novel cable-free ECG device is set to launch in the concierge medicine market by late 2025, targeting high-margin recurring revenue and leveraging strong clinical validation and FDA clearances. Expansion plans include AI-driven insights, heart attack detection, and integration into the extended wear patch market.
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Key milestones achieved include FDA clearance for the foundational system, positive pivotal study results, and a strategic partnership with AccurKardia. Financial discipline remains strong, with $11.5 million raised and commercial launch targeted for late 2025 pending FDA approval.
Fiscal Year 2024
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Achieved foundational FDA clearance and raised $11.5M to support commercialization of a novel cable-free ECG system. Early access program and pilot commercialization target a multi-billion dollar direct patient pay market, with FDA review of 12-lead software expected by year-end.
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Q3 2024 saw a net loss of $4.98M and a $5.8M cash balance, with spending focused on R&D and clinical milestones. FDA clearance is expected soon, enabling an early access program and a 2025 commercial launch, though no significant revenue is anticipated next year.
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AIMIGo, a cable-free 12-lead ECG device, is progressing through FDA review with a limited launch expected by year-end 2024. Q2 net loss widened to $5 million on higher R&D and G&A expenses, with $9.2 million in cash remaining. Clinical and AI milestones continue to advance.