HeartSciences Announces De Novo Submission to FDA for Innovative MyoVista® wavECG™ Device

12 lead ECG device detects LV relaxation impairment associated with Left Ventricular Diastolic Dysfunction

 

SOUTHLAKE, TEXAS – December 9, 2019 – HeartSciences, a medical device company focused on advancing the field of electrocardiology through innovation, announced submission to the U.S. Food and Drug Administration (FDA) via De Novo premarket review pathway for the MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device. The De Novo pathway is used for novel medical devices that are low to moderate risk.

“HeartSciences seeks to bridge today’s “diagnostic gap” in cardiac care through innovation in front-line ECG solutions that assist in the detection of heart disease in at-risk patients. Abnormal left ventricular relaxation is typically the earliest manifestation of diastolic dysfunction,” said Mark Hilz, HeartSciences’ CEO. “LV diastolic function is also now well understood to be impaired by all of the common heart disease processes that affect LV function. Thus, detecting impaired relaxation through the use of 12-lead ECG testing can be a game-changer for front-line heart disease testing.”

“This is an important milestone and the result of years of research and development focused on
advancing the field of electrocardiography. Through the use of advanced technology, it is now possible to develop new algorithms focused on detecting cardiac states related to heart disease not previously detected by conventional ECG devices.” said Andrew Simpson, HeartSciences’ Executive Chairman.

HeartSciences’ request for De Novo classification is supported by clinical data collected in prospective, non-randomized, clinical studies conducted at three institutions which were aggregated into an overall clinical study dataset. The subject data (n=395 Validation Dataset) used to validate the performance of the wavECG Algorithm was not used in any aspect of the development of the wavECG Algorithms.

About HeartSciences and the MyoVista Device
HeartSciences’ MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device is a new resting 12-lead electrocardiograph that uses continuous wavelet transform (CWT) signal processing to extract additional frequency information from the acquired ECG signal. This new information is a key aspect of the MyoVista wavECG AI-based Algorithm that is designed to detect left ventricular (LV) relaxation abnormalities which are typically the earliest manifestation of left ventricular diastolic dysfunction (LVDD). Extensive research confirms that almost all forms and co-morbidities of heart disease are associated with LVDD including hypertension, diabetes, valvular disease, ischemia, and reduced systolic function.

The MyoVista wavECG Device is an innovative advancement for electrocardiographic testing designed to provide physicians with new information to improve patient risk-assessment related to heart disease and in determining whether a patient should receive further testing, evaluation and/or treatment.

The MyoVista Device additionally provides all the information and capabilities of a full-featured
conventional resting 12-lead ECG within the same test and follows the same clinical AHA/IEC lead placement protocol.

HeartSciences (formerly known as Heart Test Laboratories) is a privately held U.S. corporation based in Southlake, Texas.

For more information visit www.heartsciences.com.

Corporate contact
Gene Gephart
+1 737 414 9213
gene.gephart@heartsciences.com