HeartBeam Announces Positive Data from Two Studies at Prestigious American Heart Association Conference
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) ha presentato risultati positivi da due studi durante le Sessioni Scientifiche dell'American Heart Association, convalidando la sua tecnologia di monitoraggio cardiaco basata su vettori. Il primo studio, un pilot di 80 pazienti, ha dimostrato un'eccellente corrispondenza tra l'ECG a 12 derivazioni sintetizzato di HeartBeam e gli ECG standard per la rilevazione di aritmie, mostrando una sensibilità del 94% e una specificità del 100%. Il secondo studio ha convalidato un algoritmo innovativo per la valutazione del rischio di sindrome coronarica acuta, corrispondente alle valutazioni di medici esperti. La tecnologia dell'azienda utilizza un dispositivo portatile, delle dimensioni di una carta di credito, in grado di sintetizzare ECG a 12 derivazioni, attualmente in fase di revisione da parte della FDA.
HeartBeam (NASDAQ: BEAT) presentó resultados positivos de dos estudios en las Sesiones Científicas de la Asociación Americana del Corazón, validando su tecnología de monitoreo cardíaco basada en vectores. El primer estudio, un piloto de 80 pacientes, demostró una excelente concordancia entre el ECG de 12 derivaciones sintetizado por HeartBeam y los ECG estándar para la detección de arritmias, mostrando un 94% de sensibilidad y un 100% de especificidad. El segundo estudio validó un nuevo algoritmo para la evaluación del riesgo de síndrome coronario agudo, coincidiendo con las evaluaciones de expertos médicos. La tecnología de la empresa utiliza un dispositivo portátil del tamaño de una tarjeta de crédito que es capaz de sintetizar ECG de 12 derivaciones, actualmente bajo revisión de la FDA.
HeartBeam (NASDAQ: BEAT)는 미국 심장 협회의 과학 세션에서 두 연구의 긍정적인 결과를 발표하며 자사의 벡터 기반 심장 모니터링 기술을 검증했습니다. 첫 번째 연구, 80명의 환자를 대상으로 한 파일럿 연구에서는 HeartBeam의 합성 12-유도 ECG와 표준 ECG 간에 아리듀미아 탐지에서 뛰어난 일치를 보여주었으며, 감도는 94%, 특이도는 100%에 달했습니다. 두 번째 연구는 급성 관상동맥 증후군 위험 평가를 위한 새로운 알고리즘을 검증했으며, 전문가 의사의 평가와 일치했습니다. 이 회사의 기술은 12유도 ECG를 합성할 수 있는 신용 카드 크기의 휴대용 장치를 사용하며, 현재 FDA 검토 중입니다.
HeartBeam (NASDAQ: BEAT) a présenté des résultats positifs de deux études lors des Sessions Scientifiques de l'American Heart Association, validant sa technologie de surveillance cardiaque basée sur des vecteurs. La première étude, un pilote de 80 patients, a démontré une excellente concordance entre l'ECG à 12 dérivations synthétisé par HeartBeam et les ECG standard pour la détection des arythmies, montrant 94 % de sensibilité et 100 % de spécificité. La deuxième étude a validé un nouvel algorithme pour l'évaluation du risque de syndrome coronarien aigu, correspondant aux évaluations d'experts médicaux. La technologie de l'entreprise utilise un dispositif portable de la taille d'une carte de crédit capable de synthétiser des ECG à 12 dérivations, actuellement en cours d'examen par la FDA.
HeartBeam (NASDAQ: BEAT) hat positive Ergebnisse aus zwei Studien während der wissenschaftlichen Sitzungen der American Heart Association präsentiert, die ihre vektorbasierte Herzüberwachungstechnologie validieren. Die erste Studie, eine Pilotstudie mit 80 Patienten, zeigte eine ausgezeichnete Übereinstimmung zwischen dem synthetisierten 12-Kanal-ECG von HeartBeam und den Standard-ECGs zur Arrhythmieerkennung mit einer Empfindlichkeit von 94% und einer Spezifität von 100%. Die zweite Studie validierte einen neuartigen Algorithmus zur Risikoabschätzung des akuten Koronarsyndroms, der mit den Bewertungen erfahrener Ärzte übereinstimmte. Die Technologie des Unternehmens verwendet ein tragbares, kreditkartengroßes Gerät, das in der Lage ist, 12-Kanal-ECGs zu synthetisieren und sich derzeit in der Prüfung durch die FDA befindet.
- Excellent clinical results with 94% sensitivity and 100% specificity in arrhythmia detection study
- Successful validation of ACS risk assessment algorithm matching expert physician evaluations
- Technology demonstrates comparable performance to standard 12-lead ECGs
- Product still pending FDA approval
Insights
The clinical validation data from two studies significantly strengthens HeartBeam's position in the cardiac monitoring space. The first study shows 94% sensitivity and 100% specificity in arrhythmia detection compared to standard 12-lead ECGs - impressive metrics that validate the technology's accuracy. The second study's successful validation of the ACS risk score algorithm represents a potential breakthrough in remote heart attack detection.
The technology addresses a critical gap in cardiac care by providing hospital-grade ECG capabilities in a credit card-sized device. This could substantially reduce the "time-to-treatment" window for heart attack patients, where every minute counts for survival and recovery outcomes. The dual validation of both arrhythmia and ACS detection capabilities significantly de-risks the technology and positions HeartBeam for potential market leadership in portable cardiac monitoring.
This double validation at a prestigious conference represents a important milestone for HeartBeam's commercialization pathway. With the FDA review underway and strong clinical data, the company is well-positioned to target the $1.8 billion global cardiac monitoring devices market. The technology's dual capability in detecting both arrhythmias and potential heart attacks could drive significant market adoption, particularly given the rising prevalence of cardiovascular diseases and the growing demand for remote monitoring solutions.
The endorsement from leading institutions like Piedmont Healthcare and Beth Israel Deaconess Medical Center adds substantial credibility. For a small-cap company (
- The studies further strengthen HeartBeam’s body of clinical evidence for its portable, cable-free, credit card-sized device that is designed to be capable of synthesizing a 12-lead ECG
- The first study is a pilot study demonstrating similar performance of HeartBeam’s vector-based ambulatory technology to standard 12-lead ECGs for arrhythmia detection
- The second study is a feasibility study highlighting the potential of HeartBeam’s technology with a novel risk-score assessment algorithm to evaluate chest pain remotely and reduce delays in care for patients experiencing a heart attack
HeartBeam’s vector-based technology captures the heart’s electrical signals from three dimensions. The Company’s first application of its groundbreaking technology is a cable-free, credit card-sized device that is designed to be capable of synthesizing a 12-lead electrocardiogram (ECG). The small size makes it convenient for patients to always have the device with them, ready to record an ECG whenever they feel symptoms to minimize delays in care. The HeartBeam system is currently under review with the FDA.
“The data presentations at AHA are a testament to HeartBeam’s dedication to building a robust body of clinical evidence to support our groundbreaking technology as we strive to make it easier for patients and physicians to monitor cardiac symptoms and seek timely diagnosis outside of a healthcare facility,” said Robert Eno, Chief Executive Officer, HeartBeam. “We thank our physician collaborators for their commitment to evaluating the value our technology can bring in different clinical situations and transform how cardiac conditions are managed in the future.”
The first presentation by Thomas Deering, MD, FACC, FHRS, Chief of Arrhythmia Center, Piedmont Healthcare in
“One of the main challenges with timely assessment of arrhythmias is that a single-lead ECG does not contain complete diagnostic information, and at the same time, obtaining a standard 12-lead ECG is highly impractical outside of a medical setting,” commented Dr. Deering. “Our study showed that the synthesized 12-lead ECG obtained from the HeartBeam device is similar to a 12-lead ECG, allowing patients to easily obtain the highest fidelity ECG data wherever they are upon symptom onset and greatly reduce any potential delays in receiving care.”
A second study presented by Alexei Shvilkin, MD, PhD, Clinical Cardiac Electrophysiologist, Beth Israel Deaconess Medical Center in
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The Company is creating the first ever cable-free 12-lead ECG capable of capturing the heart’s electrical signals from three dimensions. This platform technology is designed to be used in portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. The Company holds 13 US and 4 international issued patents related to technology enablement.
For additional information, visit HeartBeam.com.
Forward-Looking Statements
All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
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Source: HeartBeam, Inc.
FAQ
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