05/09/2023
We have news: HeartSciences (NASDAQ:HSCS) Announces Completion of Patient Enrollment for FDA Pivotal Study of MyoVista wavECG
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 (NASDAQ:HSCS), 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 (2).”
About HeartSciences�Heart Test Laboratories, Inc. d/b/a HeartSciences is a next-generation, AI electrocardiogram (AI ECG) company focused on using AI to transform the ECG (also known as the EKG) to save lives through earlier detection of heart disease. Millions of ECGs are performed every week and AI is creating a new era of opportunity for the ECG with recent AI ECG applications described as, “some of the most significant advances in electrocardiography since its inception(1).” The Company’s objective is to become a fixture in front-line healthcare settings to help physicians make better and earlier referral decisions for at-risk patients.
Notes
(1) Khurram Nasir, MD, MPH, MSC,et. al., Journal of American College of Cardiology Editorial Comment Volume 76 Number 8 2020.
(2) Dalane W. Kitzman and William C. Little, Circulation Volume 125 Issue 6 2012.
Safe Harbor Statement�
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ filings with the U.S. Securities and Exchange Commission at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
See the full release: https://www.globenewswire.com/news-release/2023/05/09/2664416/0/en/HeartSciences-Announces-Completion-of-Patient-Enrollment-for-FDA-Pivotal-Study-of-MyoVista-wavECG.html
