HeartBeam, Inc. announced 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. The first patients were enrolled at Atlanta Heart Specialists, a top cardiology physician practice in Atlanta, GA. 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 quantitative methodologies for assessment of arrhythmias. HeartBeam AIMIGiography leverages HeartBeam's proprietary 3Dvectorelectrocardiography (3D VECG) technology to capture signals in three projections (X, Y, Z) and synthesize a 12-lead ECG. 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. 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.

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.

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 second quarter 2024. 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 second quarter 2024.