HeartBeam announces VALID-ECG pivotal study met primary endpoint

HeartBeam (BEAT) announced that its synthesized 12-lead electrocardiogram successfully met the clinical endpoints in the VALID-ECG pivotal study. Thomas Deering presented the data during the just concluded Heart Rhythm Society’s annual conference in San Diego. The study evaluated the mean difference in ECG intervals and amplitudes between HeartBeam’s synthesized 12-lead ECG and simultaneously collected standard 12-lead ECG that are important in assessing non-life-threatening arrhythmias. Data showed a 93.4% overall diagnostic agreement, indicating that HeartBeam’s synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12-lead ECGs. HeartBeam’s patented 3D ECG technology captures the heart’s electrical signals in 3 non-coplanar directions and then synthesizes these signals into a 12-lead ECG using a personalized transformation matrix. Data from the VALID-ECG study formed the basis of the FDA application for the 12-lead ECG synthesis software submitted by HeartBeam in January. The company plans to initiate commercialization upon receiving FDA clearance for the 12-lead ECG synthesis software. In advance of that, the company recently commenced an Early Access Program to obtain important feedback on the end-to-end clinical workflow, ensure operational readiness and establish an early adopter funnel in anticipation of U.S. commercialization. The VALID-ECG pivotal study was a multicenter trial that enrolled 198 patients across five clinical sites in the US, including Allegheny Health Network, Atlanta Heart Specialists, Mount Sinai Hospital, Northwell Health and Piedmont Heart Institute.