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- Commercial Readiness Plans Accelerating in Anticipation of FDA 510(k) Clearance for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software for Arrhythmia Assessment<\/i><\/li>\n
- Anticipated FDA Clearance in Q4 2025 is a Major Inflection Point as HeartBeam Evolves into a Commercial-Stage Company Focused on Growth<\/i><\/li>\n
- Announced Partnership with HeartNexus to Provide On-Demand Cardiologist Reviews of Synthesized 12-Lead ECGs for Arrhythmia Assessment and Triage Patients<\/i><\/li>\n
- Data Presented at AHA Scientific Sessions and HRX Live 2025 Continue to Advance HeartBeam\u2019s Pipeline for Ischemia Detection and Deep Learning Algorithms<\/i><\/li>\n
- Management to Host Webcast and Conference Call Today at 4:30 p.m. ET<\/i><\/li>\n<\/ul>\n
SANTA CLARA, Calif.–(BUSINESS WIRE<\/a>)–HeartBeam, Inc.<\/b><\/a> (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, has reported its financial and operational results for the third quarter ended September 30, 2025.<\/p>\n
Third Quarter & Subsequent 2025 Operational Highlights<\/b><\/p>\n
\nThe Company continues to make significant progress towards commercial readiness, along with key clinical and regulatory achievements on the HeartBeam System.<\/p>\n
12-Lead ECG Synthesis Software FDA Submission:<\/i><\/b><\/p>\n
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- \nHeartBeam is engaging in productive discussions with the FDA and is in the final stage of FDA review for the 510(k) submission of the 12-lead ECG synthesis software in arrhythmia assessment, a major inflection point for the Company.<\/p>\n<\/li>\n
- \nThe timeline for FDA clearance remains firmly on track and is expected by the end of the year.<\/p>\n<\/li>\n<\/ul>\n
Commercial Readiness Plans:<\/i><\/b><\/p>\n
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- \nThe Company anticipates initiating commercialization upon receiving FDA 510(k) clearance, and commercial readiness plans are accelerating in anticipation of the clearance.<\/p>\n<\/li>\n
- \nHeartBeam announced a partnership with HeartNexus, Inc. to provide on-demand, board-certified cardiologist reviews of synthesized 12-lead ECGs for arrhythmia assessment and triage patients.<\/p>\n<\/li>\n
- \nThe upcoming launch represents a pivotal milestone as the Company advances towards commercialization and growth.<\/p>\n<\/li>\n<\/ul>\n
Other Highlights:<\/i><\/b><\/p>\n
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- \nNew data at AHA Scientific Sessions in November 2025 added to the body of scientific evidence supporting HeartBeam\u2019s potential for early heart attack detection.<\/p>\n<\/li>\n
- \nAn abstract on HeartBeam\u2019s AI algorithm was presented at HRX Live 2025, demonstrating continued advancement of the Company\u2019s AI program.<\/p>\n<\/li>\n
- \nHeartBeam was recognized as a global IP and technology leader in portable cardiac diagnostics in a new PatentVest report, ranking #2 worldwide in 12-lead ECG innovation out of 243 companies analyzed.<\/p>\n<\/li>\n
- \nThree (3) new patents were issued in the quarter, with a total of 24 patents now issued worldwide.<\/p>\n<\/li>\n
- \nROTH Capital initiated coverage on HeartBeam with a Buy rating and $4 price target ahead of the anticipated FDA clearance for the 12-lead ECG synthesis software.<\/p>\n<\/li>\n
- \nCash and cash equivalents totaled $1.9 million as of September 30, 2025, with net cash used in operating activities of $3.2 million for the three months ended September 30, 2025, resulting in an 8% decrease quarter-over-quarter.<\/p>\n<\/li>\n<\/ul>\n
Management Commentary<\/b><\/p>\n
\n\u201cIn the third quarter, we made significant progress with commercial readiness plans in anticipation of FDA clearance for the 12-lead ECG synthesis software submission for arrhythmia assessment,\u201d said Robert Eno, Chief Executive Officer, HeartBeam. \u201cWe continue to engage in positive and productive discussions with the FDA and our anticipated timeline for this clearance by year end remains intact. Combined with the foundational FDA clearance received in December 2024, this clearance marks a major inflection point for the Company to initiate our commercial launch.<\/p>\n
\n\u201cThe focus of our commercial launch will be establishing HeartBeam as the first personal, cable-free, synthesized 12-lead ECG for arrhythmia assessment. At the core of our product offering is the HeartBeam System paired with a 24\/7 cardiology reader service. The announcement of the partnership with HeartNexus will provide our users access to a network of U.S.-based, board-certified cardiologists specializing in cardiac test interpretation.<\/p>\n
\n\u201cWhile we remain laser-focused on achieving our upcoming FDA clearance and launching the HeartBeam System in the concierge and preventive cardiologist market, we continue to make meaningful progress on several fronts. Scientific data was presented on heart attack detection and our AI program, adding to our body of clinical evidence. Three new patents were issued last quarter on our core technology, bringing the total to 24 global patents. We are pleased to have been recognized as a world leader in IP for 12-lead ECGs. Taken together, we believe we are well positioned for long-term value creation for our shareholders,\u201d concluded Eno.<\/p>\n
Third Quarter 2025 Financial Results<\/b><\/p>\n
\nResearch and development expenses for the third quarter of 2025 were $3.3 million, compared to $2.9 million for the third quarter of 2024.<\/p>\n
\nGeneral and administrative expenses for the third quarter of 2025 were $2.0 million compared to $2.2 million for the third quarter of 2024.<\/p>\n
\nNet loss for the third quarter of 2025 was $5.3 million, compared to a net loss of $5.0 million for the third quarter of 2024.<\/p>\n
\nNet cash used in operating activities was $11.1 million for the nine months ended September 30, 2025, as compared to $10.3 million for the nine months ended September 30, 2024. Net cash used in operating activities was $3.2 million for the three months ended September 30, 2025, an 8% decrease quarter-over-quarter.<\/p>\n
\nCash and cash equivalents totaled $1.9 million as of September 30, 2025, as compared to $2.4 million at December 31, 2024.<\/p>\n
Third Quarter 2025 Results Conference Call<\/b><\/p>\n
\nHeartBeam CEO Robert Eno and CFO Tim Cruickshank will host the conference call, followed by a question-and-answer period. The conference call will be accompanied by a presentation, which can be viewed during the webcast or accessed via the investor relations section of the Company\u2019s website here<\/a>.<\/p>\n
\nTo access the call, please use the following information:<\/p>\n
- Anticipated FDA Clearance in Q4 2025 is a Major Inflection Point as HeartBeam Evolves into a Commercial-Stage Company Focused on Growth<\/i><\/li>\n
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