HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software
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) ha presentato una richiesta 510(k) alla FDA per il suo software di sintesi ECG a 12 derivazioni, progettato per valutare vari ritmi cardiaci e aritmie. La richiesta è supportata dallo studio fondamentale VALID-ECG, che ha arruolato 198 pazienti in cinque siti clinici.
Il software si basa sulla tecnologia recentemente approvata dalla FDA di HeartBeam, che cattura i segnali elettrici del cuore da tre direzioni e li sintetizza in un ECG a 12 derivazioni utilizzando una matrice di trasformazione personalizzata. L'azienda prevede di lanciare commercialmente il prodotto dopo l'approvazione della FDA, con centinaia di medici e pazienti già in lista d'attesa.
I dati di uno studio pilota su 80 persone presentati alle AHA Scientific Sessions hanno mostrato un'eccellente concordanza tra gli ECG sintetizzati da HeartBeam e gli ECG standard a 12 derivazioni per la rilevazione delle aritmie, con una sensibilità del 94% e una specificità del 100%. L'azienda prevede di presentare i risultati di VALID-ECG in una conferenza scientifica nel 2025.
HeartBeam (NASDAQ: BEAT) ha presentado una solicitud 510(k) a la FDA para su software de síntesis de ECG de 12 derivaciones, diseñado para evaluar varios ritmos cardíacos y arritmias. La presentación está respaldada por el estudio pivotal VALID-ECG, que incluyó a 198 pacientes en cinco sitios clínicos.
El software se basa en la tecnología que HeartBeam ha obtenido recientemente la aprobación de la FDA, que captura señales eléctricas del corazón desde tres direcciones y las sintetiza en un ECG de 12 derivaciones utilizando una matriz de transformación personalizada. La empresa planea lanzar comercialmente el producto tras la aprobación de la FDA, con cientos de médicos y pacientes ya en lista de espera.
Los datos de un estudio piloto de 80 personas presentados en las Sesiones Científicas de la AHA mostraron una excelente concordancia entre los ECG sintetizados de HeartBeam y los ECG estándar de 12 derivaciones para la detección de arritmias, con una sensibilidad del 94% y una especificidad del 100%. La empresa planea presentar los resultados de VALID-ECG en una conferencia científica en 2025.
HeartBeam (NASDAQ: BEAT)는 FDA에 다양한 심장 리듬 및 부정맥을 평가하기 위해 설계된 12유도 ECG 합성 소프트웨어에 대한 510(k) 신청서를 제출했습니다. 이 제출은 VALID-ECG 주요 연구에 의해 뒷받침되며, 이 연구는 5개의 임상 사이트에서 198명의 환자를 모집했습니다.
이 소프트웨어는 심장의 전기 신호를 세 방향에서 포착하고 이를 개인화된 변환 행렬을 사용하여 12유도 ECG로 합성하는 HeartBeam의 최근 FDA 승인 기술을 기반으로 합니다. 회사는 FDA의 승인이 나는 대로 상업 발매를 계획하고 있으며, 이미 수백 명의 의사와 환자가 대기 명단에 올라 있습니다.
AHA 과학 회의에서 발표된 80명 규모의 파일럿 연구 데이터는 HeartBeam의 합성 ECG와 부정맥 탐지를 위한 표준 12유도 ECG 간의 뛰어난 일치를 보여주었으며, 94%의 민감도와 100%의 특이성을 기록했습니다. 회사는 2025년 과학 회의에서 VALID-ECG 결과를 발표할 계획입니다.
HeartBeam (NASDAQ: BEAT) a soumis une demande 510(k) à la FDA pour son logiciel de synthèse d'ECG à 12 dérivations, conçu pour évaluer différents rythmes cardiaques et arrhythmies. La soumission est soutenue par l'étude pivot VALID-ECG, qui a inclus 198 patients sur cinq sites cliniques.
Le logiciel s'appuie sur la technologie récemment approuvée par la FDA de HeartBeam, qui capture les signaux électriques du cœur sous trois angles et les synthétise en un ECG à 12 dérivations à l'aide d'une matrice de transformation personnalisée. L'entreprise prévoit de lancer son produit commercialement après l'approbation de la FDA, avec déjà des centaines de médecins et de patients sur liste d'attente.
Les données d'une étude pilote de 80 personnes présentées lors des sessions scientifiques de l'AHA ont montré une excellente concordance entre les ECG synthétisés par HeartBeam et les ECG standard à 12 dérivations pour la détection des arythmies, avec une sensibilité de 94 % et une spécificité de 100 %. L'entreprise prévoit de présenter les résultats de VALID-ECG lors d'une conférence scientifique en 2025.
HeartBeam (NASDAQ: BEAT) hat einen 510(k) Antrag bei der FDA für seine Software zur Synthese von 12-Kanal-EKGs eingereicht, die zur Bewertung verschiedener Herzrhythmen und Arrhythmien entwickelt wurde. Der Antrag wird durch die VALID-ECG-Pivotal-Studie unterstützt, an der 198 Patienten an fünf klinischen Standorten teilnahmen.
Die Software baut auf der kürzlich von der FDA genehmigten Technologie von HeartBeam auf, die die elektrischen Signale des Herzens aus drei Richtungen erfasst und sie mit einer personalisierten Transformationsmatrix in ein 12-Kanal-EKG synthetisiert. Das Unternehmen plant, nach der Genehmigung durch die FDA kommerziell zu starten, wobei bereits Hunderte von Ärzten und Patienten auf der Warteliste stehen.
Daten aus einer 80-Personen-Pilotstudie, die bei den AHA-Wissenschaftssitzungen präsentiert wurden, zeigten eine exzellente Übereinstimmung zwischen den synthetisierten EKGs von HeartBeam und standardmäßigen 12-Kanal-EKGs bei der Erkennung von Arrhythmien, mit einer Sensitivität von 94% und einer Spezifität von 100%. Das Unternehmen plant, die VALID-ECG-Ergebnisse auf einer wissenschaftlichen Konferenz im Jahr 2025 zu präsentieren.
- FDA 510(k) submission completed for 12-lead ECG synthesis software
- Strong clinical data from VALID-ECG study with 198 patients
- Excellent pilot study results showing 94% sensitivity and 100% specificity
- High market interest with hundreds of physicians and patients on waitlist
- Recent FDA clearance for core technology already achieved
- Commercial launch pending FDA clearance
- Full VALID-ECG study results not yet presented
Insights
HeartBeam's FDA submission marks a pivotal milestone in portable cardiac diagnostics, backed by compelling clinical validation. The VALID-ECG study's 198-patient enrollment across five clinical sites demonstrates robust data collection, while the pilot study's exceptional performance metrics (94% sensitivity, 100% specificity) suggest strong clinical equivalence to standard 12-lead ECGs.
The technology's unique value proposition lies in its ability to synthesize comprehensive 12-lead ECG data from just three leads, potentially disrupting the $2+ billion cardiac monitoring market. The substantial physician and patient waitlist for the Early Access Program indicates strong market demand and potential rapid adoption upon clearance.
Several key factors enhance the probability of FDA clearance: 1) The recent FDA clearance of their underlying signal capture technology 2) The robust clinical validation data 3) The clear clinical need for portable cardiac monitoring solutions. The planned AI integration for heart attack detection aligns with the American Heart Association's focus on reducing 'symptom to door' times, potentially opening additional market opportunities.
The commercial strategy appears well-structured, with the Early Access Program providing valuable real-world feedback before full launch. This approach could accelerate market penetration while minimizing implementation challenges. The technology's ability to detect multiple arrhythmias, including atrial fibrillation, flutter and PVC/PAC, positions it as a comprehensive solution for both routine monitoring and acute cardiac event detection.
The market timing for HeartBeam's technology is particularly advantageous, coinciding with the healthcare industry's shift toward remote monitoring solutions. The cardiac monitoring device market is experiencing robust growth, driven by an aging population and increasing prevalence of cardiovascular diseases.
The technology's potential market impact is amplified by several key differentiators:
- Synthesis of complete 12-lead ECG data from a portable device
- Validated accuracy comparable to standard ECGs
- Convenience factor for both patients and healthcare providers
- Future AI integration capabilities
The extensive waitlist for the Early Access Program suggests strong market pull rather than push, indicating potential for rapid market penetration. The technology's comprehensive arrhythmia detection capabilities position it favorably for both primary care and specialist adoption, potentially expanding the addressable market beyond traditional cardiac monitoring applications.
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia assessment.
The submission builds on HeartBeam’s recent FDA clearance for its patented technology which captures the heart’s electrical signals from three distinct directions. The software synthesizes these signals into a familiar 12-lead ECG using a personalized transformation matrix.
Upon FDA clearance for the software, the Company plans to initiate commercial launch leveraging the learnings and feedback gained from its Early Access Program. Hundreds of physicians and patients have already joined the waitlist underscoring the widespread interest in a powerful and convenient cardiac monitoring option that can be used outside of a medical facility.
Robert Eno, Chief Executive Officer of HeartBeam, commented, “The FDA submission for the 12-lead synthesis software is a significant step as we work towards fulfilling HeartBeam’s vision to offer patients and physicians an easy-to-use portable device and transform how cardiac conditions are monitored and detected.”
Additional future planned advances include the integration of AI-based classification algorithms and detection of heart attacks to aid in reducing “symptom to door” times – an area of major focus for the American Heart Association (AHA) to shorten the time from heart attack symptom onset and treatment. HeartBeam believes its groundbreaking technology presents a transformative opportunity to bring about a paradigm shift in cardiovascular care for millions of patients globally.
Additional Details About Data Supporting FDA Submission
The FDA submission was supported by data from the VALID-ECG pivotal study, which completed enrollment in June 2024. VALID-ECG used the same protocol as an 80-person pilot study which was presented at the AHA 2024 Scientific Sessions. The Company plans to present the results from VALID-ECG at a scientific conference in 2025.
Data from the pilot study presented at the AHA Scientific Sessions, which also supported the FDA submission, found similar performance of HeartBeam’s synthesized 12-lead ECG waveforms compared to simultaneously collected standard 12-lead ECGs for arrhythmia detection. The pilot study found excellent agreement when physicians diagnosed various arrhythmias utilizing the HeartBeam synthesized 12-lead ECG compared to a standard 12-lead ECG (Sensitivity:
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first ever cable-free synthesized 12-lead ECG capable of capturing the heart’s electrical signals from three distinct directions. This platform technology is designed for 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.
About the HeartBeam System
The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional. For full safety information, see the full Instructions for Use or Clinician Portal Manual.
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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Investor Relations Contact:
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
BEAT@mzgroup.us
www.mzgroup.us
Media Contact:
media@heartbeam.com
Source: HeartBeam, Inc.
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