HeartSciences Announces Clinical Study Results in the Journal of the American College of Cardiology (JACC)

Study demonstrates MyoVista® wavECG™ ability to cost-effectively detect LV Dysfunction

 

SOUTHLAKE, Texas, August 18, 2020 – HeartSciences, a medical device company focused on advancing the field of electrocardiology through innovation, announced today the results of a multicenter prospective study conducted at 4 centers in North America enrolling a total of 1,202 subjects. The study was supported in part by funds from HeartSciences and the National Science Foundation. The results are provided at online JACC.org and will be published in the August 25, 2020 issue of Journal of the American College of Cardiology (JACC), a peer-reviewed journal in cardiovascular medicine. The participating centers are The Icahn School of Medicine, Mount Sinai Hospital, New York, NY, The West Virginia University (WVU) Heart and Vascular Institute, Morgantown, WV, The Windsor Cardiac Centre, Windsor, Ontario, Canada and the David Geffen School of Medicine at UCLA, Los Angeles, California.

The article titled “Machine Learning Assessment of Left Ventricular Diastolic Function Based on Electrocardiographic Features” presents the results from evaluating the feasibility of MyoVista® wavECGTM  Technology to provide quantitative estimates related to myocardial relaxation that can be used to identify left ventricular diastolic dysfunction (LVDD). Diastolic dysfunction is recognized as playing a major role in the pathophysiology of heart failure.  Heart disease is a global pandemic affecting at least 26 million people worldwide and continues to increase in prevalence due to increasing life expectancy in the general population.  New tools are needed that can assist in identifying patients earlier while also lowering costs for health systems around the world.

The study was performed using machine learning analysis often described as artificial intelligence or AI. Machine-learning models were developed to estimate e’ (e-prime) using signal-processed ECG features, traditional ECG features and clinical information. Patients from 3 institutions (n= 814) formed a development cohort and were randomly divided into training and internal test sets (80:20).  Data from the fourth institution was reserved as an external test set (n = 388) to evaluate model performance.

The study results demonstrated that the estimated e? values discriminated the guideline-recommended thresholds for abnormal myocardial relaxation, LVDD and systolic dysfunction (LV ejection fraction) with an AUC of 0.84, 0.80, and 0.81 respectively in the external test set.  Moreover, the estimated e’ allowed prediction of LV diastolic dysfunction based on multiple age and sex-adjusted reference limits with an AUC of 0.94 in the external test set.

Conclusions of the study include: “This cost-effective strategy may be a valuable first clinical step for assessing the presence of LV dysfunction and potentially aid in the early diagnosis and management of heart failure patients” and “This novel approach has the potential to serve as a cost-effective screening tool for early detection of LVDD.”

Partho Sengupta, MD, Professor, Chief of Cardiology and Chair of Cardiac Innovation, WVU Heart & Vascular Institute, the principal investigator commented “The study focused on developing a quantitative estimation of a key echocardiographic measure. The results demonstrate a potentially significant new role for electrocardiography in cardiac testing and reducing overall healthcare costs”

“This large-scale study using MyoVista wavECG Technology, demonstrates that new LV dysfunction detection capabilities developed using advanced signal processing and AI can provide improved low-cost testing for heart disease.” stated Mark Hilz, President and CEO of HeartSciences.

Andrew Simpson, Chairman of HeartSciences, stated “This study indicates that HeartSciences MyoVista wavECGs innovative technology has the capability and opportunity to bridge the diagnostic gap in heart disease”.

About HeartSciences

HeartSciences sits at the forefront of innovation and technological development focused on advancing the field of electrocardiology to provide early heart disease detection.  Its first product, the MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device, is a resting 12-lead electrocardiograph that uses AI and continuous wavelet transform (CWT) signal processing to provide cardiac information associated with left ventricular diastolic disfunction (LVDD), a condition which has previously not been possible to detect using conventional electrocardiology. LVDD is associated with almost all forms and co-morbidities of heart disease and may include hypertension, diabetes, valvular disease, ischemia, and reduced systolic function among others.

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 is a privately held U.S. corporation based in Southlake, Texas.

The MyoVista Device is not currently FDA cleared and is not available in the United States.

For more information visit www.heartsciences.com.

Contacts

HeartSciences
Gene Gephart
gene.gephart@heartsciences.com

HeartSciences Announces New Product Innovation Award from Frost and Sullivan

HeartSciences Announces New Product Innovation Award from Frost and Sullivan

MyoVista® AI-based ECG Device detects Left Ventricle Dysfunction

 

SOUTHLAKE, TEXAS – July 28, 2020– HeartSciences, a medical device company focused on advancing the field of electrocardiology through innovation, announced it has been awarded a New Product Innovation Award – Europe by Frost & Sullivan, a leader in global research and consulting solutions.

HeartSciences MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device uses artificial intelligence to detect left ventricular (LV) relaxation abnormalities related to LV diastolic dysfunction (LVDD), an early indicator of most forms of heart disease.  Specifically, the MyoVista wavECG Device provides information relating to the echo measurement e’ which has previously not been possible using an ECG.

LV diastolic function is 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 is a potential game-changer for front-line heart disease testing.

“We are pleased that HeartSciences’ MyoVista wavECG Technology has been recognized by Frost & Sullivan,” said Mark Hilz, President and CEO.  “Through technology leadership HeartSciences is demonstrating new possibilities in the capability of an ECG to effectively detect a wider range of heart disease conditions. We believe our first indication for LV relaxation abnormalities will be the first of many.”

Frost & Sullivan analysts follow a 10-step process to evaluate Award candidates and assess their fit with select best practice criteria. The reputation and integrity of the Awards are based on close adherence to this process. The firm’s 360-degree research methodology represents the analytical rigor of its research process, offering a 360-degree-view of industry challenges, trends, and issues by integrating all 7 of Frost & Sullivan’s research methodologies into an evaluation platform for benchmarking industry players and for identifying those performing at best-in-class levels.

About HeartSciences

HeartSciences’ sits at the forefront of innovation and technological development focused on advancing the field of electrocardiology to provide early heart disease detection.  Its first product, the MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device, is a resting 12-lead electrocardiograph that uses AI and continuous wavelet transform (CWT) signal processing to provide cardiac information associated with left ventricular diastolic disfunction (LVDD), a condition which has not been possible to detect previously using electrocardiology. LVDD is associated with almost all forms and co-morbidities of heart disease including hypertension, diabetes, valvular disease, ischemia, and reduced systolic function.

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 is a privately held U.S. corporation based in Southlake, Texas.

The MyoVista Device is not currently FDA cleared and is not available in the United States.

About Frost & Sullivan

Frost & Sullivan enables clients to accelerate growth and achieve best in class positions in growth, innovation, and leadership. The company’s Growth Partnership Service provides the CEO and the CEO’s Growth Team with disciplined research and best practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages almost 50 years of experience in partnering with Global 1000 companies, emerging businesses, and the investment community from 31 offices on 6 continents. To join our Growth Partnership, please visit www.frost.com.

For more information about HeartSciences or the MyoVista Wavelet ECG please visit www.heartsciences.com.

Corporate contact

Gene Gephart

+1 737 414 9213

gene.gephart@heartsciences.com

 

HeartSciences’ MyoVista Study on the Detection of Abnormal MyoCardial Relaxation Highlighted in AHA Article

 

CARDIOLOGY 2.0 – HeartSciences Seeks FDA Approval for Innovative MyoVista wavECG Device

HeartSciences, a medical device company focused on advancing the field of electrocardiology through innovation, announced submission to the U.S. 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.

Mark Hilz

“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.

South Lake, Texas-based 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.

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

 

MyoVista Wavelet ECG Cardiac Testing Device Showcased at 2019 ESC – Paris, France

MyoVista Wavelet ECG Cardiac Testing Device Showcased at 2019 ESC – Paris, France

HeartSciences, a medical device company developing next generation ECG devices using continuous wavelet transform (CWT) signal processing and artificial intelligence, is proud to have participated as an exhibitor at the 2019 European Society of Cardiology Congress (ESC) in Paris, France from August 31 to September 4, 2019. HeartSciences is advancing the field of electrocardiography through the application of wavelet signal processing and artificial intelligence to develop next generation ECG technology.

HeartSciences Named Among ‘50 Smartest Companies of the Year 2018’ by The Silicon Review Magazine

HeartSciences Named Among ‘50 Smartest Companies of the Year 2018’ by The Silicon Review Magazine

Southlake, Texas – Silicon Review, a leading Business and Technology magazine has named HeartSciences, as one of the 50 Smartest Companies of the Year 2018.

The Silicon Review 50 Smartest Companies of the Year 2018 program identifies companies that mastered the discipline of smartness and stood high among the crowd,” said Sreshtha Banerjee, Editor-in-Chief of The Silicon Review Magazine.

We are honored to be recognized by The Silicon Review Magazine as the one of the 50 Smartest Companies of 2018,” said Mark Hilz, CEO at HeartSciences. “HeartSciences use of patented signal processing methods combined with artificial intelligence is designed to bridge today’s “diagnostic gap” in cardiac care by providing low-cost effective solutions that help to identify cardiac dysfunction in the diastolic phase.”

See Full Article

HeartSciences Showcases MyoVista® Wavelet ECG at 2018 European Society of Cardiology Congress (ESC)- Hall A, Booth G320

HeartSciences Showcases MyoVista® Wavelet ECG at 2018 European Society of Cardiology Congress (ESC)

Hall A, Booth G320

 

SOUTHLAKE, Texas, August 20, 2018 –(BUSINESSWIRE)—HeartSciences, a medical device company developing next generation ECG devices using continuous wavelet transform (CWT) signal processing and artificial intelligence is proud to announce its participation as an exhibitor at the upcoming 2018 European Society of Cardiology Congress (ESC). The Congress will take place at Messe Munich International in Munich, Germany and will run from August 25 to August 29, 2018. HeartSciences will highlight it’s MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device as well as recent clinical study results published in the Journal of the American College of Cardiology (JACC)

The JACC article titled “Prediction of Abnormal Myocardial Relaxation from Signal Processed Surface ECG” presented the results from the investigator-initiated clinical study that focused on evaluating the feasibility of MyoVista® Wavelet ECG as a diagnostic tool for predicting myocardial relaxation abnormalities. Results from the study demonstrate MyoVista’s patented technology based on CWT signal processing can detect myocardial relaxation abnormalities associated with LVDD.

About HeartSciences

HeartSciences is advancing the field of electrocardiography through the application of wavelet signal processing and artificial intelligence to develop next generation ECG technology. Wavelet signal processing is currently used in many different industries as an important tool to provide insights and new valuable data related to spectral analysis of a signal. HeartSciences’ MyoVista wavECG Cardiac Testing Device is a 12-lead resting electrocardiograph utilizing continuous wavelet transform (CWT) based signal processing. Patented informatics focus on energy related information rather than conventional voltage-based information. HeartSciences mission is to enable accurate, affordable screening for the early detection of heart disease.

In addition to the proprietary informatics, the MyoVista wavECG Device also features the capabilities of a full featured 12-lead resting ECG including analysis using the Glasgow Algorithm, one of the world’s most respected interpretive algorithms. The device has a 15.6-inch high-resolution touchscreen display and incorporates many features commonly associated with a tablet device requiring minimal user training as well as easy and intuitive use. The MyoVista wavECG Device is not currently approved for sale or distribution in the United States and is not currently FDA cleared.

HeartSciences is a privately-held U.S. corporation based in Southlake, Texas.

For more information visit www.heartsciences.com.

Contacts

HeartSciences
Gene Gephart, +1-737-346-1089
gene.gephart@heartsciences.com

 

Investor Contact

Zimmons International Communications

Jennifer K. Zimmons, +1-917-214-3514

jzimmons@zimmonsic.com

 

 

 

HeartSciences Showcases MyoVista® Wavelet ECG at the 2018 International Congress on Electrocardiology (ICE)

SOUTHLAKE, Texas, June 25, 2018 –(BUSINESSWIRE)—HeartSciences, an innovative medical device company, is proud to announce its participation as an exhibitor at the upcoming 2018 International Congress on Electrocardiology (ICE), which will be held in Makuhari Messe, Chiba City, Japan, June 28-30, 2018. ICE2018 will be the joint meeting of the 45th Congress of the International Society of Electrocardiology (ISE) and the 18th Congress of the International Society for Holter and Noninvasive Electrocardiology (ISHNE). This Congress will focus on Electrocardiography, from noninvasive diagnosis to prognosis covering basic electrophysiology, novel signal processing methods of Holter ECG, prognostic ECG techniques for preventing sudden cardiac death, applications of antiarrhythmic agents and direct oral anticoagulants, a critical role of catheter ablation for tachyarrhythmias and appropriate use of implantable devices.

About HeartSciences

HeartSciences is leading innovation in the field of electrocardiography through the application of continuous wavelet transform (CWT) signal processing and artificial intelligence. Wavelet signal processing is currently used in many different industries as an important tool to provide insights and new valuable data related to spectral analysis of a signal. HeartSciences’ MyoVista® Wavelet ECG (wavECG™) is a first-to-market 12-lead resting electrocardiograph with new informatics based on wavelet signal processing. Patented informatics focus on energy related information rather than conventional voltage-based information. HeartSciences mission is to enable accurate, affordable screening for the early detection of heart disease.

In addition to proprietary informatics, the MyoVista wavECG Device has full 12-lead resting ECG capabilities including analysis using the Glasgow Algorithm, one of the world’s most respected interpretive algorithms. The device has a 15.6-inch high-resolution touchscreen display and incorporates many features commonly associated with a tablet device requiring minimal user training with no change in ECG clinical workflow. The MyoVista wavECG Device is not currently FDA approved for commercial sale or distribution in the United States.

HeartSciences is a privately-held U.S. corporation based in Southlake, Texas.

For more information visit www.heartsciences.com.

Contacts

HeartSciences
Gene Gephart, +1-737-346-1089
gene.gephart@heartsciences.com