HeartSciences Announces Closing of License Agreements with the Icahn School of Medicine at Mount Sinai to Develop and Commercialize AI Cardiovascular Algorithms

Southlake, TX, Nov. 20, 2023 (GLOBE NEWSWIRE) -- 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 closing of its license agreements with the Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai), in New York, NY, to develop and commercialize electrocardiographic AI algorithms and assets. The licenses result in Icahn Mount Sinai becoming a shareholder in the Company.

Andrew Simpson, Chief Executive Officer of HeartSciences, said, "We continue to advance initiatives that fundamentally transform and de-risk HeartSciences.  The closing of our licenses with Icahn Mount Sinai now propels us forward with our cardiovascular disease AI-ECG development programs.  Combined with the recent creation of a new FDA product classification for AI-ECG algorithms that we believe paves the way for a more structured and quicker 510(k) process of our technologies, we have clear focus on our target milestones," said Andrew Simpson, CEO of HeartSciences. “We believe AI-based ECG algorithms close the diagnostic gap to detect heart disease much earlier and at a lower cost and we look forward to accelerating commercialization and broadening the range of prospective solutions that we will provide.”

Erik Lium, PhD, the Chief Commercial Innovation Officer at the Mount Sinai Health System and President of Mount Sinai Innovation Partners, said, "We look forward to working with HeartSciences, a company that aims to bring new AI-powered ECG capabilities to market in an effort to enable the early detection of heart disease and, ultimately, improve the lives of patients."

The licenses from Icahn Mount Sinai grant rights to multiple patented and unpatented AI-based ECG/EKG algorithms and technologies for the screening and diagnosis of cardiovascular disease. The licenses 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, allowing HeartSciences to accept ECGs from millions of existing ECG devices around the world, including its MyoVista device. The algorithms were developed using a database of millions of ECG records, enabling researchers to develop a range of AI-based ECG algorithms using state-of-the art data science methods.

The AI cardiovascular algorithms are based on technology developed by Icahn Mount Sinai faculty and licensed by Mount Sinai to HeartSciences. Mount Sinai and Icahn Mount Sinai faculty, including Girish Nadkarni, MD, Irene and Dr. Arthur M. Fishberg Professor of Medicine at Icahn Mount Sinai, System Chief of the Division of Data-Driven and Digital Medicine (D3M), Co-Director of the Mount Sinai Clinical Intelligence Center (MSCIC), and Co-Director of The Charles Bronfman Institute for Personalized Medicine; Akhil Vaid, MD, Instructor in the Division of Data-Driven and Digital Medicine (D3M) at Icahn Mount Sinai; Joshua Lampert, MD, Medical Director of Machine Learning for Mount Sinai Fuster Heart Hospital; Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai; and Son Duong, MD, Assistant Professor of Pediatrics (Pediatric Cardiology) at Icahn Mount Sinai, have a financial interest in this technology and in HeartSciences. The financial interest of Mount Sinai faculty is pursuant to the Mount Sinai Intellectual Property Policy.

About HeartSciences

Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG's clinical usefulness. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making an ECG a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test. The business model, which involves the use of the MyoVista® Device and consumables for each test, is expected to be "razor-razorblade" as the electrodes used with the MyoVista® are proprietary to HeartSciences, and new electrodes are required for every test performed.

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Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2023, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 18, 2023, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2023, filed with the SEC on September 14, 2023, and in HeartSciences' other filings with the SEC at Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

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