HeartSciences Receives FDA Confirmation for 510(k) Clearance Pathway

Southlake, TX, Dec. 05, 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 that it has received confirmation from the FDA to change the clearance pathway for its MyoVista® wavECG™ device and associated AI-ECG algorithm to a more standard 510(k) submission from the more complex De Novo process.

Andrew Simpson, Chief Executive Officer of HeartSciences, said, "The new FDA product classification for AI-ECG paves the way for a more structured and faster 510(k) process for our MyoVista® device, as well as our industry leading library of AI-ECG algorithms.  We also intend to deliver these algorithms using a cloud-based, hardware agnostic platform that will provide innovative AI-ECG diagnosis from millions of existing ECG devices around the world, in addition to our MyoVista® device.” Mr. Simpson added, “The switch to 510(k) will require some changes, but we believe it will result in faster clearance overall. In November, the core lab finished their work on our MyoVista® pivotal study following the conclusion of patient recruitment announced earlier in 2023. We remain on track for submission of the MyoVista® to the FDA in the first half of 2024 and a targeted clearance during 2024.”

About HeartSciences

Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG's clinical usefulness. Undetected heart disease is one of the biggest challenges in healthcare and millions of ECGs are performed every week. The Company's objective is to improve healthcare by making an ECG a far more valuable cardiac screening tool. 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. HeartSciences also has an industry leading library of AI-ECG algorithms, technologies and patent rights developed using millions of ECG records which the Company intends to deliver using a cloud-based, hardware agnostic platform to accept ECGs from millions of existing ECG devices around the world, in addition to the MyoVista®.

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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.

Contacts:

HeartSciences

Gene Gephart

(US)

Investors

Gilmartin Group

Vivian Cervantes