Clinical study will evaluate HTL’s Next Generation ECG technology designed to enable low cost screening for Heart Disease
Westlake, TX, December 10, 2015 – Heart Test Laboratories, Inc. (HTL) announces the start of a clinical study of its MyoVista device by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed). This study will compare the results of the MyoVista test to an established testing method, Cardiac Computed Tomography Angiography (CCTA). Dr. Matthew Budoff is the principal investigator. The study will compare MyoVista results to subclinical measures of atherosclerosis (CAC and CT angiography) in 200 subjects at risk for coronary disease. Correlations between the MyoVista reading and the presence of calcified plaque, soft plaque, and CTA stenosis will be determined. The study is expected to last between 6 months to 1 year.
This study has the potential to confirm MyoVista as a reliable and sensitive marker of atherosclerosis. Findings may provide a strong indication for the value of a MyoVista test to confirm Coronary Artery Disease (CAD) in clinical practice, and for the clinical application of MyoVista in management of coronary disease and atherosclerosis.
In 2010, nearly 800,000 Americans died of cardiovascular, cerebrovascular, or renal disease. Over 120 million Americans are affected by some type of circulatory disease whether heart disease, hypertension, or stroke. However, in the USA, there are few validated commercially available, non-invasive, and accurate techniques to assess cardiac disease. With the exception of blood pressure and Framingham risk markers, all other measurements currently require costly and specialized equipment. However, the MyoVista a new non-invasive device, is now available for clinical study.
Furthermore, and importantly, in addition to identifying which patients might progress to later stages of disease, the earlier detection may also allow the device to be used to assess therapeutic progress.
A novel electrocardiographic recording method, the MyoVista obtains and processes signal information in a way that permits high resolution of the electrical activity associated with the myocardium. The clinical set up of this technique is identical to traditional 12-lead ECG, however, the recording is focused on the early detection of myocardial abnormalities by non-linear analysis of electrophysiological phenomenon propagated by changes of cellular metabolism level in the cardiac muscle, and the direction, timing and velocity of ion flow. This novel assessment may be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases, and may be especially of value in patients at risk for coronary artery disease.
About LA BioMed
Founded in 1952, LA BioMed is one of the country's leading nonprofit independent biomedical research institutes. It has approximately 100 principal researchers conducting studies into improved diagnostics and treatments for cancer, inherited diseases, infectious diseases, illnesses caused by environmental factors and more. It also educates young scientists and provides community services, including prenatal counseling and childhood nutrition programs. LA BioMed is academically affiliated with the David Geffen School of Medicine at UCLA and located on the campus of Harbor-UCLA Medical Center. For more information, please visit www.LABioMed.org
About Dr. Budoff
Dr. Matthew Budoff is a fellow of the American College of Cardiology and the American Heart Association, the president of the Society of Cardiovascular Computed Tomography, the principal investigator at the Los Angeles Biomedical Research Institute at Harbor- UCLA Medical Center and the author of more than 300 articles and four textbooks.
About Heart Test Laboratories, Inc. (“HTL”)
HTL develops medical devices using patented technology that focus on the early detection of heart disease. The MyoVista’s innovative technology facilitates the early identification of ischemic and other heart abnormalities which can enable improved screening for coronary arterial disease and other cardiac abnormalities.
The MyoVista provides two tests in one and is easy for physicians to administer and interpret. By using standard 12-lead resting ECG protocols, the MyoVista provides an ECG test incorporating interpretive analysis, plus easy to understand proprietary informatics that assist a physician in identifying heart disease at an early stage. The MyoVista provides additional information to physicians in their decision process to refer patients to a cardiologist for further diagnostic testing and treatment.
The MyoVista has a 15.6 inch high resolution touchscreen and incorporates user features and functionality commonly associated with a tablet device which make it intuitive and easy to use thereby reducing training time. Its proprietary informatics provide information to physicians that suggest ischemic and certain types of structural heart abnormalities. The MyoVista is ideally suited for use in both primary care and hospital environments.
Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. The MyoVista helps to address the “diagnostic gap” in heart disease today, which is the identification of asymptomatic patients prior to an adverse cardiac event, such as a heart attack.
HTL expects to seek FDA clearance for the MyoVista in the near future. Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information visit hearttestlabs.com.
Contact: Mark Hilz, CEO