HeartSciences announces completion of patient enrollment for FDA pivotal study of MyoVista wavECG

2023-05-10

临床研究

The study has enrolled more than 600 patients at five geographically dispersed centers located across the United States HeartSciences announces completion of patient enrollment for FDA pivotal study of MyoVista wavECG. (Credit: Gerd Altmann from Pixabay) Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), 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. Andrew Simpson, CEO of HeartSciences, stated, “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. Millions of ECGs are performed every week and we look forward to leading the commercialization of new AI ECG indications for use to make the ECG a far more valuable cardiac test. We are grateful to the clinical institutions and physicians involved in our pivotal study for their diligent work over the past couple of years. 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.” Almost all forms of heart disease affect heart muscle, or cardiac, function including prior to symptoms. Impaired cardiac function is first observed as impaired left ventricular (LV) cardiac relaxation, an early indicator of LV diastolic dysfunction that increases in severity as heart disease progresses and is also associated with age-related cardiac dysfunction. As Kitzman and Little pointed out in their 2012 paper published in Circulation, “LV diastolic function is impaired by all the common pathological processes that affect LV function or produce LV hypertrophy or fibrosis, including hypertension, diabetes mellitus, ischemia, myocarditis, toxins, and infiltrative cardiomyopathies. Thus, LV diastolic performance is a sensitive indicator of cardiovascular dysfunction.” Source: Company Press Release

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