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- Redirected the Majority of Company Resources to Heart Attack Assessment, a Market Opportunity 4x Larger than the Arrhythmia Market<\/i><\/li>\n
- Received FDA Breakthrough Device Designation for Heart Attack Assessment and Accepted into FDA’s Total Product Life Cycle Advisory Program (TAP)<\/i><\/li>\n
- Reported Positive ALIGN-ACS Pilot Study Results at TCT 2026 with HeartBeam Patient-Recorded ECG Demonstrating Higher Specificity Than Standard 12-Lead ECG for Heart Attack Assessment<\/i><\/li>\n
- U.S. Pivotal Study for Heart Attack Assessment Planned to Begin in First Quarter of 2027<\/i><\/li>\n
- Created Capital Efficiency with Focused Path to Heart Attack Assessment, Resulting in a 23% Reduction in Quarterly Operating Cash Outflows<\/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, today reported its financial and operational results for the third quarter ended September 30, 2026.<\/p>\n
Third Quarter & Subsequent 2026 Operational Highlights<\/b><\/p>\n
\nIn September 2026, the Company sharpened its strategy and directed the majority of its financial and personnel resources to heart attack assessment, which it views as its largest value-creation opportunity. Since then, HeartBeam has received FDA Breakthrough Device Designation, been accepted into FDA’s TAP program, completed enrollment in HEADSTART-ACS, its largest heart attack assessment study to date, and reported positive pilot results from ALIGN-ACS at TCT 2026. The Company now plans to finalize the U.S. pivotal study design in the fourth quarter of 2026 and begin patient enrollment in the first quarter of 2027.<\/p>\n
Heart Attack Assessment: Strategic Focus<\/i><\/b><\/p>\n
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- \nIn September 2026, the Company announced it is redirecting the majority of its resources to heart attack (myocardial infarction, or MI) assessment.<\/p>\n<\/li>\n
- \nMore than 20 million U.S. adults are at elevated risk of a heart attack, a population the Company estimates is approximately four times larger than the arrhythmia market.<\/p>\n<\/li>\n
- \nThe Company estimates the MI opportunity at approximately $15 billion, within a broader cardiac platform opportunity exceeding $40 billion.<\/p>\n<\/li>\n<\/ul>\n
Regulatory Progress<\/i><\/b><\/p>\n
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- \nIn October 2026, received FDA Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home.<\/p>\n<\/li>\n
- \nFDA granted the Breakthrough designation within 30 days of the Company’s request, ahead of the agency’s 60-day statutory review period.<\/p>\n<\/li>\n
- \nIn October 2026, the HeartBeam System was accepted into FDA’s Total Product Life Cycle Advisory Program (TAP), which provides dedicated FDA advisors and early engagement with payers, including the Centers for Medicare & Medicaid Services.<\/p>\n<\/li>\n
- \nIn October 2026, the Company reached alignment with the FDA on a 510(k) pathway for the heart attack assessment indication.<\/p>\n<\/li>\n
- \nThe Company plans to initiate its U.S. pivotal study in the first quarter of 2027 leveraging results from the ALIGN-ACS pilot study to finalize the design of the study in the fourth quarter of 2026.<\/p>\n<\/li>\n
- \nThe U.S. pivotal study is intended to support a future FDA submission to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack assessment.<\/p>\n<\/li>\n<\/ul>\n
Positive Pilot Study Results Presented at TCT 2026<\/i><\/b><\/p>\n
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- \nALIGN-ACS pilot study results were presented by Graham Nichol, MD, MPH, FRCP(C), of the University of Washington, at TCT 2026 in San Diego.<\/p>\n<\/li>\n
- \nThe study enrolled 132 adults at the emergency departments of two major cardiology centers in Belgrade, Serbia, and evaluated the diagnostic accuracy of the HeartBeam System compared with a standard 12-lead ECG in assessing acute coronary syndrome (ACS).<\/p>\n<\/li>\n
- \nEight cardiologists, blinded to each patient’s diagnosis, independently interpreted both HeartBeam and standard 12-lead ECG recordings. Interpretations were compared with each patient’s final diagnosis as determined by an independent panel of three cardiologists.<\/p>\n<\/li>\n<\/ul>\n
\nKey findings:<\/p>\n
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- Higher specificity, comparable sensitivity. <\/b>HeartBeam showed higher specificity than standard 12-lead ECG (81.8% vs. 71.4%) with comparable sensitivity (60.2% vs. 63.0%), pointing to its potential as a rule-in diagnostic aid.\n<\/li>\n
- Comparable sensitivity in STEMI assessment<\/b>. For ST-elevation myocardial infarction, the most time-sensitive form of heart attack, sensitivity was 82.9% for HeartBeam vs. 83.8% for standard 12-lead ECG.\n<\/li>\n
- More consistent interpretation.<\/b> Cardiologists agreed more often when reading HeartBeam recordings (Fleiss’ kappa 0.73 vs. 0.54 for standard 12-lead ECG).\n<\/li>\n
- Patient ease of use<\/b>. 100% of patients recorded their own HeartBeam ECG under clinical supervision with no prior training, supporting potential use outside traditional clinical settings.\n<\/li>\n<\/ul>\n
Growing Body of Clinical Evidence<\/i><\/b><\/p>\n
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- \nIn October 2026, completed enrollment ahead of schedule in HEADSTART-ACS, the largest heart attack assessment study to date using HeartBeam technology.<\/p>\n<\/li>\n
- \nThe study enrolled 486 emergency department patients with chest pain at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia.<\/p>\n<\/li>\n
- \nIndonesia, the world’s fourth most populous country, represents a strategically significant market of 288 million people.<\/p>\n<\/li>\n
- \nTogether with ALIGN-ACS, the Company now has clinical experience with more than 600 patients in heart attack assessment.<\/p>\n<\/li>\n
- \nIn October 2026, joined the EU-co-funded EXIT-CVD research consortium as a contributing partner, alongside Philips, Medtronic, GE HealthCare and other global healthcare organizations.<\/p>\n<\/li>\n
- \nHeartBeam will lead the HEART-CHECK study, one of EXIT-CVD’s 22 clinical studies, evaluating the HeartBeam System for early detection and triage of cardiac events in high-risk patients recently discharged after an acute coronary syndrome.<\/p>\n<\/li>\n<\/ul>\n
Other Operational Highlights:<\/b><\/p>\n
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- \nIn July 2026, HeartBeam was awarded a new U.S. patent covering the integration of acoustic sensing and thoracic impedance measurement into the Company\u2019s existing ECG hardware platform, supporting future applications in structural heart disease and heart failure monitoring. The Company\u2019s patent portfolio includes 26 issued patents worldwide.<\/p>\n<\/li>\n
- \nCash and cash equivalents totaled $6.1 million as of September 30, 2026, compared to $4.4 million as of December 31, 2025. Net cash used in operating activities was $2.6 million for the third quarter of 2026, a 23% decrease compared to the second quarter of 2026 and an 18% decrease compared to the third quarter of 2025.<\/p>\n<\/li>\n<\/ul>\n
Management Commentary<\/b><\/p>\n
\n“The third quarter marked a decisive turn for HeartBeam,” said Richard Ferrari, Executive Chairman. “We committed the majority of our resources to heart attack assessment, and the milestones have quickly followed. In just the last six weeks, we received FDA Breakthrough Device Designation, were accepted into FDA’s TAP program, and aligned with the FDA on a 510(k) submission pathway for a heart attack assessment indication. We also completed enrollment in HEADSTART-ACS ahead of schedule and presented positive results from the ALIGN-ACS pilot study at TCT showing higher specificity than the standard 12-lead ECG. With clinical experience in more than 600 patients and no new hardware required, we are focused on beginning our U.S. pivotal study in the first quarter of 2027.”<\/p>\n
\nBranislav Vajdic, Ph.D., Founder and President of HeartBeam, added, \u201cToday, a person with chest pain at home has no reliable way to know whether it is a heart attack, and that uncertainty results in delays and potentially worse outcomes. Our goal is to shorten the time between the first sign of symptoms and the decision to seek care, by giving patients and their physicians clinical-grade cardiac information when every minute matters. We believe HeartBeam can help close that gap for the millions of people at risk.\u201d<\/p>\n
Third Quarter 2026 Financial Results<\/b><\/p>\n
\nSelling, general and administrative expenses for the third quarter of 2026 were $1.3 million, compared to $2.0 million for the third quarter of 2025, a decrease of 33%. The decrease in SG&A expense of $0.7 million is primarily related to a decrease in non-cash stock-based compensation expense of $0.4 million and a reduction in employee costs of $0.3 million driven by lower headcount period over period.<\/p>\n
\nResearch and development expenses for the third quarter of 2026 were $2.1 million, compared to $3.3 million for the third quarter of 2025, a decrease of 35%. The decrease in R&D expense is primarily related to the completion of product development and consulting costs related to the HeartBeam System and a prototype patch device of $0.8 million, completion of enrollment in the ALIGN-ACS pilot study of $0.3 million, and a decrease in headcount-related costs of $0.1 million.<\/p>\n
\nTotal operating expenses for the third quarter of 2026 were $3.5 million, compared to $5.3 million for the third quarter of 2025.<\/p>\n
\nNet loss for the third quarter of 2026 was $3.0 million, or $(0.05) per basic and diluted share, compared to a net loss of $5.3 million, or $(0.15) per basic and diluted share, for the third quarter of 2025.<\/p>\n
\nNet cash used in operating activities was $2.6 million for the third quarter of 2026, a 23% decrease compared to the second quarter of 2026 and an 18% decrease compared to the third quarter of 2025. Net cash used in operating activities was $9.5 million for the nine months ended September 30, 2026, compared to $11.1 million for the nine months ended September 30, 2025, a decrease of 14%.<\/p>\n
\nCash and cash equivalents totaled $6.1 million as of September 30, 2026, compared to $4.4 million as of December 31, 2025. In August 2026, the Company entered into an at-the-market sales agreement (the \u201cATM\u201d) with Titan Partners Securities LLC, as sales agent, pursuant to which the Company may sell, from time to time, shares of its common stock, par value $0.0001 per share, having an aggregate offering price of up to $25.0 million. In the fourth quarter of 2026 through the date of this release, the Company raised net proceeds of approximately $4.0 million. Giving effect to these net proceeds, the Company\u2019s pro forma cash and cash equivalents as of September 30, 2026, would have been approximately $10.1 million.<\/p>\n
Financial Outlook<\/b><\/p>\n
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- \nThird quarter 2026 operating cash outflow was lower than in the second quarter of 2026 as a result of the Company\u2019s reduced cost structure and the capital efficiency created by the focused path to heart attack assessment.<\/p>\n<\/li>\n
- \nAs outlined previously, the baseline fourth quarter 2026 operating cash outflow is expected to be below $2.5 million; accelerated U.S. pivotal study timing would add to fourth quarter spending.<\/p>\n<\/li>\n
- \nFull year 2026 net operating cash outflow is now expected to be between $12.0 million and $12.5 million, a further reduction from the Company\u2019s previous guidance.<\/p>\n<\/li>\n
- \nThe Company expects its cash runway to extend further into 2027, aligned with the achievement of key milestones.<\/p>\n<\/li>\n<\/ul>\n
Third Quarter 2026 Results Conference Call<\/b><\/p>\n
\nHeartBeam Executive Chairman Richard Ferrari, Founder and President Branislav Vajdic, Ph.D., and Chief Financial Officer Timothy 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 following the call 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
- Comparable sensitivity in STEMI assessment<\/b>. For ST-elevation myocardial infarction, the most time-sensitive form of heart attack, sensitivity was 82.9% for HeartBeam vs. 83.8% for standard 12-lead ECG.\n<\/li>\n
- Higher specificity, comparable sensitivity. <\/b>HeartBeam showed higher specificity than standard 12-lead ECG (81.8% vs. 71.4%) with comparable sensitivity (60.2% vs. 63.0%), pointing to its potential as a rule-in diagnostic aid.\n<\/li>\n
- Received FDA Breakthrough Device Designation for Heart Attack Assessment and Accepted into FDA’s Total Product Life Cycle Advisory Program (TAP)<\/i><\/li>\n
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