HeartSciences Announces Completion of Patient Enrollment for FDA Pivotal Study of MyoVista wavECG™

Southlake, TX — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through the early detection of heart disease, today announces completion of patient enrollment for its MyoVista wavECG pivotal study for FDA De Novo submission.

The study commenced in 2021 and is a prospective, multi-center study to validate the diagnostic performance of the MyoVista wavECG AI algorithm for the detection of impaired left ventricular relaxation. The study has enrolled more than 600 patients at five geographically dispersed centers located across the United States, and the data will now undergo verification and analysis which, assuming positive results, will be incorporated as part of the Company's FDA De Novo submission for the MyoVista.

"The emerging field of AI ECG offers the meaningful prospect of low-cost screening to help solve the diagnostic gap where millions of people with heart disease remain undiagnosed until some sort of cardiac event, such as a heart attack. We have invested years in artificial intelligence R&D and have designed our first product, the MyoVista, to detect cardiac dysfunction at an early stage... We are delighted to have concluded patient enrollment which has been by far the most time-consuming part of our FDA De Novo submission process," said Andrew Simpson, CEO of HeartSciences.