WESTLAKE, Texas--(BUSINESS WIRE)--Heart Test Laboratories, Inc. (HTL) announces that a clinical study initiated by Mount Sinai Medical Center, New York examining the MyoVista heart screening device has commenced. The clinical study is designed to further evaluate the MyoVista, which incorporates HTL’s patented technology for the early detection of heart disease. The study will assess the MyoVista indications for the identification of coronary arterial disease (CAD) as compared to computed tomographic coronary angiography (CTA) and myocardial dysfunction in patients without CAD as compared to echocardiography.
The lead investigator is Dr. Partho Sengupta, the Director of Cardiac Ultrasound Research and Core Lab, and an Associate Professor of Medicine in Cardiology at Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health. The clinical study is expected to enroll 200 patients and take between 12-24 months to complete. Mount Sinai is ranked as a top 10 hospital for cardiology by U.S. News’ 2015 annual survey.
Heart disease is the leading cause of death in the U.S., being responsible for 1 in every 4 deaths (approx. 600,000 per year U.S.). It is the leading cause of deaths worldwide, more than all cancers combined, and is the largest spend area in healthcare. Heart disease is known as the silent killer because most affected people do not know they have it (i.e. they are asymptomatic); more than half of patients find out through an adverse event (angina, heart attack or even death).
The “diagnostic gap” in heart disease today is non-invasive, low cost screening to identify asymptomatic patients before an adverse event occurs. Existing electrocardiography (ECG) technology is generally not considered effective for use on asymptomatic patients. The U.S. Preventive Services Taskforce and other healthcare bodies around the world recommend against screening with resting or exercise ECG for the prediction of coronary heart disease (CHD) events in asymptomatic adults at low risk for CHD events.
HTL believes the MyoVista will provide the opportunity for effective, low cost testing for heart disease in primary care. This would enable physicians to have a valuable additional tool to assist in the process of determining referrals to a cardiologist.
“We are excited that Mount Sinai has decided to initiate an important clinical study of the MyoVista. Mount Sinai is one of the most respected medical institutions in the world and has a strong reputation for research along with being recognized as a center of excellence in cardiology. Our goal is to save lives and save healthcare dollars by both finding people with heart disease much earlier, and reducing expensive cardiac testing on people that do not require treatment,” stated Mark Hilz, Heart Test Laboratories CEO.
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 use. By using standard 12-lead resting ECG protocols, the MyoVista provides an ECG test incorporating interpretive analysis, as well as 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.