Southlake, Texas, July 27, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announces that its MyoVista® wavECGTM has been selected for commercial use in clinical practice by the Naya Imaging Center in Hvidore, Denmark.
The Naya Imaging Center is a recently opened private clinic near Copenhagen in Denmark and will provide cardiac testing using the MyoVista as well as imaging and other tests with a focus on preventative screening and diagnostics. In recent years, HeartSciences has been engaged with a number of physicians in Denmark where the MyoVista is being used in clinical studies at major institutions, including Rigshospitalet Hospital, Bispebjerg Hospital, Frederiksberg Hospital and Holbæk Hospital.
The MyoVistas in Denmark are prior device versions that are covered by CE mark, rather than the updated version which will be submitted for FDA clearance. The Company intends to update the CE mark under the new EU Medical Device Regulation which is required prior to starting main sales efforts in Europe through distributors.
Andrew Simpson, CEO of HeartSciences stated, “Heart disease is placing considerable strain on health systems worldwide and is a major health and cost burden. Many international health systems have long waiting lists for cardiac testing and HeartSciences has been working internationally with a number of physicians and key institutions where there is considerable interest in the role that the MyoVista could play in improving cardiac care pathways. It is very encouraging that MyoVista wavECG is starting to be used in clinical practice and bodes well for rapid adoption following the relevant regulatory clearances."
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® wavECGTM, 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.
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 and in HeartSciences’ other filings with the SEC at www.sec.gov. 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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