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HeartBeam, Inc. (Symbol: BEAT) is a cutting-edge medical technology company that focuses on developing and commercializing high-resolution ambulatory Electrocardiogram (ECG) solutions. These solutions are designed to detect and monitor cardiac diseases outside traditional healthcare settings, providing critical diagnostic capabilities in a more accessible manner.
HeartBeam's flagship product is an innovative, credit card-sized ECG device that is diagnostically equivalent to a cardiologist reading a patient's 12-lead ECG and examining the patient. This compact device integrates seamlessly with a cloud-based diagnostic expert system, offering a comprehensive and user-friendly solution for cardiac monitoring.
Notably, studies designed by Harvard Medical School faculty have demonstrated that HeartBeam's technology performs on par with, or better than, world-class cardiologists in diagnosing heart attacks. The system features personalized diagnostic thresholds and unique ECG markers that help pinpoint the location of a heart attack on a 3D heart model, enhancing the accuracy and depth of diagnostic information provided to healthcare professionals.
One of the key components of HeartBeam's technology is the iCardiologist application, which uses artificial intelligence and machine learning to continually improve its diagnostic accuracy and predictive capabilities. This application aids cardiologists by providing detailed patient analysis, thereby supporting more informed and timely medical decisions.
HeartBeam has developed a proprietary and patented Vector Electrocardiography (VECG) technology platform, which is the cornerstone of its high-resolution ECG solutions. The company has validated this platform and is in the process of seeking U.S. Food and Drug Administration (FDA) clearance for its initial telehealth products.
With its innovative approach and proven technology, HeartBeam is poised to make significant strides in the field of cardiac care, offering practical solutions that can be utilized outside traditional healthcare environments, thereby broadening access to critical diagnostic tools and improving patient outcomes.
Latest News: Source: HeartBeam, Inc.
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HeartBeam (NASDAQ: BEAT), a medical technology company specializing in cardiac care through personalized insights, has scheduled its Q4 and Full Year 2024 earnings conference call for March 13, 2025, at 4:30 p.m. Eastern time.
The call will feature CEO Robert Eno and CFO Timothy Cruickshank, who will discuss financial results, provide updates on regulatory initiatives, commercial-readiness activities, and anticipated milestones. A detailed press release will be issued before the call, and a presentation will be available during the webcast and afterward through the company's investor relations website.
HeartBeam (NASDAQ: BEAT) has successfully completed the over-allotment option of its public offering, with the underwriter purchasing an additional 864,033 shares at $1.70 per share, generating approximately $1.5 million in additional gross proceeds. This follows the firm commitment underwritten offering of 5,882,353 shares that closed on February 14, 2025.
The total offering now comprises 6,746,386 shares with gross proceeds of approximately $11.5 million. MDB Capital acted as the underwriter, with Paulson Investment Company participating as a selected dealer. The over-allotment option closed on February 25, 2025.
The company plans to utilize the net proceeds for:
- Commercial-readiness activities
- Investments in R&D, clinical, and regulatory projects
- Working capital
- General corporate purposes
HeartBeam (NASDAQ: BEAT) has announced pricing for its underwritten public offering of 5,882,353 shares of common stock at $1.70 per share, expecting to raise $10.0 million in gross proceeds. The offering is anticipated to close around February 14, 2025.
The company has granted underwriters a 45-day option to purchase up to 882,353 additional shares to cover over-allotments. MDB Capital is serving as the underwriter, with Paulson Investment Company participating as a selected dealer.
The proceeds will support HeartBeam's strategic initiatives, including commercial-readiness activities, R&D investments, clinical and regulatory projects, working capital, and general corporate purposes. This funding follows the recent FDA clearance of HeartBeam's system for comprehensive arrhythmia assessment.
HeartBeam (NASDAQ: BEAT) has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, designed for assessing various cardiac rhythms and arrhythmias. The submission is supported by the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites.
The software builds on HeartBeam's recently FDA-cleared technology that captures heart electrical signals from three directions and synthesizes them into a 12-lead ECG using a personalized transformation matrix. The company plans to launch commercially upon FDA clearance, with hundreds of physicians and patients already on the waitlist.
Data from an 80-person pilot study presented at the AHA Scientific Sessions showed excellent agreement between HeartBeam's synthesized ECGs and standard 12-lead ECGs for arrhythmia detection, with 94% sensitivity and 100% specificity. The company plans to present VALID-ECG results at a scientific conference in 2025.
HeartBeam (NASDAQ: BEAT) announced its participation in the JP Morgan 2025 Annual Healthcare Conference, scheduled for January 13-16, 2025, in San Francisco. The company's leadership will be available for meetings to discuss their recently FDA-cleared HeartBeam system for comprehensive arrhythmia assessment.
The breakthrough device, the first of its kind to receive FDA clearance, features a credit card-sized form factor and cable-free design. It uniquely captures ECG signals from three distinct directions, providing actionable heart health information. The company plans to implement an Early Access Program and aims to leverage AI technology to analyze longitudinal ECG data, potentially predicting cardiac conditions before symptom onset.
HeartBeam (NASDAQ: BEAT) has received FDA 510(k) clearance for its innovative cardiac monitoring system. The device is the first cable-free, credit card-sized ECG that captures heart signals from three distinct directions, enabling high-fidelity data collection. When patients experience symptoms, they can use the HeartBeam app to record a 30-second ECG, which is then cloud-processed and sent to physicians for review.
The company plans to launch an Early Access Program and is developing future advances including: synthesized 12-lead ECG capabilities, AI-based classification algorithms for improved arrhythmia detection, and heart attack detection features. A study in JACC: Advances demonstrated the technology's high accuracy (95% AUC) in identifying coronary occlusions, comparable to standard 12-lead ECGs.
HeartBeam (NASDAQ: BEAT) presented positive results from two studies at the American Heart Association's Scientific Sessions, validating its vector-based cardiac monitoring technology. The first study, an 80-patient pilot, demonstrated excellent agreement between HeartBeam's synthesized 12-lead ECG and standard ECGs for arrhythmia detection, showing 94% sensitivity and 100% specificity. The second study validated a novel algorithm for acute coronary syndrome risk assessment, matching expert physician evaluations. The company's technology utilizes a portable, credit card-sized device capable of synthesizing 12-lead ECGs, currently under FDA review.
HeartBeam (NASDAQ: BEAT) reported Q3 2024 financial results, highlighting progress on its cardiac care technology. The company's FDA 510(k) submission for the HeartBeam system is under active review, with successful responses to FDA questions. Financial results show R&D expenses of $2.9M vs $1.6M in Q3 2023, and net loss of $5.0M vs $3.5M in Q3 2023. Cash position stands at $5.8M as of September 30, 2024. Key management appointments include Robert Eno as CEO, Dr. Branislav Vajdic as President, Tim Cruickshank as CFO, and Dr. Lance Myers as Chief AI Scientist.
HeartBeam (NASDAQ: BEAT) has announced its upcoming Q3 2024 earnings conference call scheduled for November 7, 2024, at 4:30 p.m. Eastern time. The call will feature CEO Robert Eno, Founder and President Branislav Vajdic, and CFO Timothy Cruickshank discussing third quarter results, regulatory updates, ongoing initiatives, and anticipated milestones. A press release with detailed results will be issued before the call. The presentation will be accessible via webcast and the company's investor relations website. A replay will be available until February 7, 2025.
HeartBeam (NASDAQ: BEAT) has been named a Rising Star in the 'Home Health Diagnostic' category at the 2024 Digital Health Hub Foundation Awards. The recognition was presented during the HLTH global healthcare conference for the company's innovative vector-based technology that captures heart electrical signals in three dimensions. The company's first application is a cable-free, credit card-sized device designed to synthesize a 12-lead ECG, currently under FDA review. HeartBeam holds 13 US patents and 4 international patents for its technology, which aims to provide comprehensive cardiac insights by leveraging AI analysis.
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