SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that it has enrolled the first patients in the VALID-ECG (Clinical Validation of the AIMIGo 12-Lead ECG Synthesis Software for Arrhythmia Detection) pivotal study.

加利福尼亚州圣克拉拉——（商业新闻短讯）——HeartBeam，Inc.（纳斯达克：BEAT），一家专注于通过个性化见解的力量改变心脏护理的医疗技术公司，今天宣布，它已经招募了第一批患者参加VALID-ECG（用于心律失常检测的AIMIGo 12导联ECG合成软件的临床验证）关键研究。

The first patients were enrolled at Atlanta Heart Specialists, a top cardiology physician practice in Atlanta, GA.

首批患者入选了佐治亚州亚特兰大市顶尖心脏病学医师——亚特兰大心脏病专家。

The VALID-ECG study will evaluate the performance of a 12-lead ECG synthesized from its credit card-sized HeartBeam AIMIGo™ system compared to that of a standard hospital-based 12-lead ECG using both quantitative and qualitative methodologies for assessment of arrhythmias. HeartBeam AIMIGo leverages HeartBeam’s proprietary 3D vectorelectrocardiography (3D VECG) technology to capture signals in three projections (X, Y, Z) and synthesize a 12-lead ECG.

VALID-ECG研究将评估由信用卡大小的HeartBeam AIMIGo™系统合成的12导联心电图与使用定量和定性方法评估心律失常的标准医院12导联心电图的性能。HeartBeam AIMIGo利用HeartBeam专有的3D矢量心电图（3D VECG）技术捕获三个投影（X、Y、Z）中的信号并合成12导联心电图。

“We are thrilled to be part of this important study as AIMIGo represents a significant leap in cardiac monitoring technology. It brings the power of 3D VECG into a familiar 12-lead ECG waveform which is used to evaluate a range of cardiac conditions on a daily basis,” said David D. Suh, MD, FACC, Director of Research at Atlanta Heart Specialists.

亚特兰大心脏专家研究中心主任、FACC医学博士David D.Suh说：“我们很高兴能够参与这项重要的研究，因为AIMIGo代表了心脏监测技术的一个重大飞跃。它将3D VECG的力量引入了一个熟悉的12导联ECG波形中，用于每天评估一系列心脏状况。”

“The attractive, small form factor of AIMIGo makes it easy for patients to use the device whenever necessary. In addition, the clinical implications of 3D VECG technology could be potentially broad-ranging and extend to a variety of applications.”.

“AIMIGo具有吸引力，体积小，便于患者在必要时使用。此外，3D VECG技术的临床意义可能广泛，并扩展到各种应用。”

More About the VALID-ECG Study and FDA Submissions

关于VALID-ECG研究和FDA提交的更多信息

The VALID-ECG Study will enroll a total of 198 patients presenting with a variety of underlying cardiac conditions at up to five US sites. All patients enrolled in the study will receive simultaneously recorded ECGs from a standard 12-lead ECG machine and the HeartBeam AIMIGo system.

VALID-ECG研究将在美国多达五个地点招募198名患有各种潜在心脏病的患者。所有参加研究的患者都将从标准的12导联心电图机和HeartBeam AIMIGo系统同时记录心电图。

The primary objective of the study is to demonstrate the equivalence of ECG waveforms between the AIMIGo synthesized 12-lead ECG and a standard 12-lead ECG by analyzing key ECG parameters called amplitudes and intervals. The study will also examine the accuracy of physician diagnosis for various arrhythmias with the AIMIGo synthesized 12-lead ECG, compared to a standard 12-lead ECG.

该研究的主要目的是通过分析称为振幅和间隔的关键ECG参数，证明AIMIGo合成的12导联ECG和标准12导联ECG之间ECG波形的等效性。与标准的12导联心电图相比，该研究还将使用AIMIGo合成的12导联心电图检查医生诊断各种心律失常的准确性。

HeartBeam’s 510(k) submission for the credit card-sized AIMIGo system is currently being reviewed by FDA. This application is for the entire 3D VECG system, which consists of the AIMIGo device, the patient application, the physician portal, and the wireless communications between them. The company expects that, when cleared, this would be the first FDA clearance for a handheld VECG system.

HeartBeam提交的510（k）信用卡大小的AIMIGo系统目前正在接受FDA的审查。该应用程序适用于整个3D VECG系统，该系统由AIMIGo设备、患者应用程序、医生门户以及它们之间的无线通信组成。该公司预计，一旦获得批准，这将是FDA首次批准手持式VECG系统。

The VALID-ECG study will be a component of HeartBeam’s subsequent 510(k) submission, which will focus on the algorithms that take the 3D VECG signal and synthesize a 12-lead ECG, providing physicians with a visual representation of the gold standard ECG output. HeartBeam expects enrollment of the VALID-ECG study to be complete in Q2 2024.

VALID-ECG研究将是HeartBeam随后提交的510（k）的一部分，该研究将重点关注获取3D VECG信号并合成12导联ECG的算法，为医生提供金标准ECG输出的视觉表示。HeartBeam预计VALID-ECG研究的注册将于2024年第二季度完成。

“The initiation of the VALID-ECG study is a major milestone for the company and a reflection of our commitment to provide a strong foundation of clinical data as we strive to provide patients and physicians with the ability to accurately monitor cardiac disease outside of a medical facility,” said Branislav Vajdic, PhD, CEO and Founder of HeartBeam.

HeartBeam首席执行官兼创始人Branislav Vajdic博士说：“VALID-ECG研究的启动是该公司的一个重要里程碑，反映了我们致力于为患者和医生提供强大的临床数据基础，以使他们能够在医疗设施之外准确监测心脏病。”

“In addition, our product pipeline includes coupling AI with our data-rich 3D VECG technology which will enable us to extract unique information and longitudinal insights to transform how cardiac care is monitored in the future.”.

“此外，我们的产品线包括将AI与我们的数据丰富的3D VECG技术相结合，这将使我们能够提取独特的信息和纵向见解，以改变未来如何监测心脏护理。”

The company has already completed an 80-patient pilot study using the same protocol as the VALID-ECG study. The company anticipates presenting the results of the pilot study at a scientific meeting in the second half of 2024. HeartBeam will also present data on its deep learning algorithm at two prestigious Electrophysiology conferences in Q2 2024.

该公司已经使用与VALID-ECG研究相同的方案完成了一项80名患者的试点研究。该公司预计将在2024年下半年的科学会议上公布试点研究的结果。HeartBeam还将在2024年第二季度的两次著名的电生理学会议上展示其深度学习算法的数据。

About HeartBeam, Inc.

关于HeartBeam，Inc.

HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company that is dedicated to transforming cardiac care through the power of personalized insights. The company’s proprietary vectorelectrocardiography (VECG) technology collects 3D signals of the heart’s electrical activity and converts them into a 12-lead ECG.

HeartBeam，Inc.（纳斯达克：BEAT）是一家医疗技术公司，致力于通过个性化见解的力量来改变心脏护理。该公司专有的向量心电图（VECG）技术收集心脏电活动的3D信号，并将其转换为12导联心电图。

This platform technology is designed to be used on portable, patient-friendly devices such as a credit-card sized monitor, watch or patch. 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 how cardiac health is managed in the future.

该平台技术旨在用于便携式、方便患者的设备，如信用卡大小的显示器、手表或补丁。医生将能够识别心脏健康趋势和急性病症，并指导患者接受适当的护理-所有这些都不在医疗机构内，从而重新定义未来如何管理心脏健康。