MyoVista wavECG goes into clinical use at the Naya Imaging Center in Denmark
July 27 2023 - 9:00AM
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."
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® 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.
For more information, please
visit: https://www.heartsciences.com.
Twitter: @HeartSciences
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.
For Investor and Media Inquiries, please contact:
Company: Gene Gephart Phone: +1-737-414-9213 (US)
Email: investorrelations@heartsciences.com
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