HeartSciences
Next-Gen ECG for Significantly Improved Heart Disease Screening

Filed FDA Pre-Submission Request to Change to 510(k) Submission from De Novo following Issuance of New Classification for AI ECG by FDA
Southlake, TX,— Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an AI-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced a conference call to update investors on recent key achievements and positive developments. The conference call will be hosted on Wednesday, October 25, 2023, at 9:00 AM ET.
• Executed license agreements with the Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai), New York, covering the rights to 13 AI-based ECG/EKG algorithms, technologies and patent rights for the screening and diagnosis of cardiovascular disease. The agreements provide HeartSciences with an industry leading library of AI-based ECG algorithms. HeartSciences intends to deliver these algorithms using a cloud-based, hardware agnostic platform to be developed, allowing HeartSciences platform to accept ECGs from millions of existing ECG devices around the world as well as its MyoVista device. The Icahn Mount Sinai AI-based ECG algorithms were developed using a database of tens of millions ECG records enabling its leading researchers to develop a range of AI-based ECG algorithms using state-of-the art data science methods. Terms and requirements related to the agreements will be discussed on the investor call or can be found in HeartSciences’ recently filed S-1 at https://ir.heartsciences.com/sec-filings.
• The Company filed an FDA Pre-Submission Request on October 2, 2023, to change to a more standard 510(k) submission from the current and more complex De Novo submission process. The FDA recently cleared an industry first De Novo clearance and created a new Class II product code for cardiovascular machine learning-based notification software in respect of a hypertrophic cardiomyopathy algorithm. In late September 2023, the FDA cleared an algorithm for low ejection fraction (less than 40%) under the 510(k)-pathway using the new product code. Accordingly, we now believe it is probable that we could submit the MyoVista algorithm for clearance under the 510(k) pathway. The 510(k) pathway is more common than De Novo and, on average, has a much quicker decision process than De Novo by the FDA. We have formally filed the request with the FDA and expect a response in late Q4 2023.
Andrew Simpson, CEO of HeartSciences, said, “We believe recent announcements fundamentally transform and de-risk HeartSciences. Our agreements with Icahn Mount Sinai is a transformative event for the Company and provide HeartSciences with the largest AI-based ECG algorithm portfolio of any commercial organization.” Mr. Simpson adds, “The AI industry continues to make exciting progress, with the recent creation of a new FDA product classification for AI ECG algorithms which we expect to make clearance more structured and quicker under the 510(k) process. We believe AI-based ECG algorithms are the bridge that will finally allow front-line healthcare professionals to close the diagnostic gap and detect heart disease much earlier and at a lower cost.”
Conference Call and Webcast
HeartSciences will host a conference call on Wednesday, October 25, 2023, at 9:00 AM ET to discuss highlights of the collaboration agreement.
Participants may access the conference call live via webcast on the investor relations section of HeartSciences’ websites or via this link. Alternatively, you may access the live conference call by dialing 1-877-423-9813 (U.S) or 1-201-689-8573 (international) and using the conference ID: 13742271. An audio archive of the webcast will be available following the call on the Investors page at https://ir.heartsciences.com/.

Southlake - Heart Test Laboratories, Inc., operating under the name HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), a medical technology company utilizing artificial intelligence (AI) to revolutionize ECGs/EKGs for early detection of heart disease, has officially named Benjamin Glicksberg, Ph.D., to its Scientific Advisory Board.
“We are delighted to welcome Dr. Glicksberg, an elite data scientist and an instrumental leader in the establishment of the AI-ECG program at the Icahn School of Medicine at Mount Sinai, New York (Mount Sinai) to HeartSciences’ Scientific Advisory Board,” said Andrew Simpson, CEO of HeartSciences. “In 2024, following the recent closing of our agreements with Mount Sinai covering an industry leading portfolio of AI-based ECG/EKG algorithms, technologies and patent rights for the screening and diagnosis of cardiovascular disease, we are focused on achieving significant milestones that include bringing forward a hardware agnostic cloud platform to deliver the portfolio of AI-ECG algorithms licensed from Mount Sinai, in addition to FDA clearance of our MyoVista wavECG device. As part of this process, we are actively expanding our Scientific Advisory Board to include industry experts and broaden our outreach. We are excited to work with Dr. Glicksberg and look forward to him bringing valuable insights and expertise as we focus on our mission of expanding the clinical diagnostic capabilities of the ECG/EKG.”
Dr. Glicksberg has played a key role as a lead investigator and creator of several algorithms, which have been licensed by HeartSciences from Mount Sinai. His expertise lies at the intersection of machine learning, digital health, and bioinformatics. Currently, Dr. Glicksberg holds the position of Vice President and Head of Data Science and Machine Learning on the leadership team of Character Biosciences, a company dedicated to drug discovery and development, utilizing human genetics and medical imaging-based machine learning. Before this role, Dr. Glicksberg served as an Assistant Professor specializing in AI for Human Health and Genetics and Genomic Sciences at Mount Sinai, where he earned his Ph.D. Additionally, he completed postdoctoral work at the University of California, San Francisco.
Ben Glicksberg, Ph.D., said, “AI-ECG technology is poised to transform the early detection of heart disease, which imposes an enormous global cost and health burden. HeartSciences stands out as one of the few companies actively bringing new AI-powered ECG capabilities to the healthcare market. I am impressed by their proven track record of innovation and look forward to contributing to HeartSciences at the forefront of this field.”

Southlake - Heart Test Laboratories, Inc., operating under the name HeartSciences (Nasdaq: HSCS; HSCSW), commonly referred to as "HeartSciences" or the "Company," a medical technology firm leveraging artificial intelligence (AI) to revolutionize ECGs/EKGs for the early detection of heart disease and thereby contributing to life-saving efforts, has officially appointed Jordan B. Strom, M.D., M.Sc., to its Scientific Advisory Board.
“Dr. Strom has been assisting us in recent interactions with the FDA and we are delighted to welcome him to our Scientific Advisory Board as we prepare for FDA submission of our MyoVista device and cloud platform, in addition to algorithms licensed from the Icahn School of Medicine at Mount Sinai, New York. Dr. Strom has expertise in AI-based medical devices and is a consultant to GE Healthcare, Phillips Healthcare, and Edwards Life Sciences. He is a leading cardiologist specializing in echocardiology, has over 90 published papers, and has served in several leadership positions for the American Society of Echocardiography,” said Andrew Simpson, CEO of HeartSciences. “As we actively expand our Scientific Advisory Board to broaden our outreach in preparedness for AI-ECG transforming the early detection of heart disease, we are excited to partner with and prosper from Dr. Strom’s expertise.”
Dr. Jordan Strom currently holds the position of Director of the Echocardiography Laboratory and Director of Echocardiographic Research at Beth Israel Deaconess Medical Center in Boston, Massachusetts. He also serves as an Assistant Professor of Medicine at Harvard Medical School and holds the role of Section Head for Cardiovascular Imaging Research at the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology.
His extensive research, supported by funding from the National Institutes of Health and the American Heart Association, focuses on assessing the relationship between cardiac structure and function and health outcomes. Dr. Strom's work also delves into optimizing the utilization and timing of cardiac imaging in medical practice. With over 90 papers published in peer-reviewed journals, he is an active member of the editorial board and serves as a guest editor for the Journal of the American Society of Echocardiography.
Dr. Strom's contributions extend to leadership roles in professional organizations. Notably, he was the first member of the American Society of Echocardiography (ASE) Leadership Academy to be elected to the Board of Directors of the ASE. This achievement marked him as the youngest individual to serve in this capacity. Additionally, he has been involved in leadership roles within the American College of Cardiology Imaging Council Leadership Committee. Dr. Strom holds a position on the Board of Directors of the International Contrast Ultrasound Society and serves as the American College of Cardiology (ACC) representative on the Board of Directors of the Joint Review Committee on Education in Diagnostic Medical Sonography. This committee is responsible for accrediting sonography training programs in the United States. Furthermore, he serves as the ACC Commissioner to the Commission on Accreditation of Allied Health Education Programs, the largest programmatic accreditor of health sciences professions, recognizing over 2,100 education programs across 32 health sciences occupations.
Expressing his perspective, Jordan B. Strom, M.D., M.Sc., stated, “The application of artificial intelligence and machine learning to the ECG presents an exciting opportunity to enhance the clinical capabilities of this diagnostic tool for the detection of a broader spectrum of heart diseases. Detecting heart disease at an earlier stage holds the potential to save lives and reduce overall healthcare costs. HeartSciences is at the forefront of innovation in this field, and I am eager to contribute to unlocking the potential power of AI-powered ECGs to enable clinicians to provide timely and optimal care.”

Southlake - Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that the Canadian Intellectual Property Office Application No. 3,000,369 has been granted by the Canadian Intellectual Property Office.
Andrew Simpson, Chief Executive Officer of HeartSciences, commented, “Millions of conventional ECG’s are performed worldwide every week and AI-ECG technology is set to change medicine by providing the opportunity to detect heart disease earlier and more effectively, while reducing treatment costs. We are pleased to receive this latest patent grant in Canada. Over recent years we have conscientiously built an extensive international intellectual property portfolio across major markets which we expect will provide competitive advantage and intrinsic corporate value as AI is set to drive significant growth in the ECG market to $25 billion per year by 20321.”
The United States Patent and Trademark Office has issued eight utility patents and one design patent to HeartSciences, with patent expiration dates ranging from March 2031 through August 2040. In addition, HeartSciences has 14 international design registrations and 19 international utility patents granted in jurisdictions such as China, Japan, South Korea, the United Kingdom, France, Germany, Mexico, the United Arab Emirates, Brazil, and Australia, with expiration dates ranging from September 2036 through March 2037.

Data Demonstrated the Use of MyoVista wavECGTM for Screening Preoperative Patients for LVDD Can Be Recommended
Southlake - Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced the podium presentation of a study utilizing its MyoVista® wavECG device at the 18th World Congress of Anesthesiologists in Singapore.
Preoperative left ventricular diastolic dysfunction (LVDD) is very common and one of the important causes of perioperative morbidity and mortality in cardiac and non-cardiac surgeries. In the study, patients undergoing preoperative anesthesia evaluation for cardiac and non-cardiac surgeries were enrolled. For patients indicated for preoperative echocardiography, LVDD was diagnosed and graded as per American Society of Echocardiography (ASE) guidelines and a MyoVista wavECG was also performed.
The author of the study stated in his presentation, “In our cohort of mixed surgical population, the MyoVista wavECG was useful as a screening tool with 100% sensitivity. Based on these findings, 25 of the 60 non-LVDD patients could be safely excluded from referral to preoperative echocardiography. Also, MyoVista wavECG can raise red flag for more detailed examination by expert cardiologists when findings are positive.” The author concluded, “The use of MyoVista wavECG for screening preoperative patients for LVDD to reduce the burden of referrals to preoperative echocardiography may be feasible and should be investigated further.”
“Once again, MyoVista wavECG has demonstrated significant potential value for screening in a large, at-risk patient population. The presentation of this study using the MyoVista to the World Congress of Anesthesiologists comes on the back of a recent publication assessing the use of MyoVista for identifying heart disease in diabetic patients1, which demonstrated MyoVista significantly outperformed existing standards of care,” said Andrew Simpson, Chief Executive Officer of HeartSciences. “AI-ECG and MyoVista provide the opportunity to screen for heart disease and transform cardiovascular medicine. We look forward to making the MyoVista device commercially available in the short term and also bringing to market a range of AI-ECG algorithms via a hardware agnostic platform. In combination, this will allow HeartSciences to provide AI-ECG solutions in any care environment worldwide.”