HeartSciences’ AI-ECG Algorithms Assigned CMS Medicare and Medicaid Reimbursement
13 11월 2024 - 11:00PM
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 Centers for
Medicare & Medicaid Services (CMS) has included AI-ECG
technology in the 2025 Hospital Outpatient Prospective Payment
System (OPPS) final rule under assignment APC 5734. This approval
would allow outpatient settings to receive reimbursement for
HeartSciences’ MyoVista® wavECGTM algorithm and MyoVista®
InsightsTM low ejection fraction algorithm, upon FDA clearance. The
payment rate is expected to be $125.
Andrew Simpson, CEO of HeartSciences, said, “The
inclusion of AI-ECG for reimbursement by CMS represents a
significant milestone for commercialization of our products and
further validates the enormous market opportunity, particularly
given the widespread use of the ECG in clinical practice. We look
forward to submitting to the FDA and bringing to market both our
MyoVista wavECG and MyoVista Insights platform in 2025.”
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 utility. Millions of ECGs are
performed every week and the Company's objective is to improve
healthcare by making it a far more valuable cardiac screening tool,
particularly in frontline or point-of-care clinical settings.
HeartSciences has one of the largest libraries of AI-ECG algorithms
and is developing AI-ECG solutions to be made available on either a
hardware agnostic cloud-based platform or its proprietary MyoVista®
wavECG™ device, to help identify cardiovascular disease in any care
setting worldwide in a manner to best suit different care
providers. 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.
For more information, please
visit: https://heartsciences.com/. X: @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, 2024, filed with the U.S. Securities and Exchange
Commission (the "SEC") on July 29, 2024, HeartSciences’ Quarterly
Report on Form 10-Q for the fiscal quarter ended July 31, 2024,
filed with the SEC on September 12, 2024 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.
Contacts:
HeartSciences Gene Gephart +1-682-244-2578
info@heartsciences.com
Investors Gilmartin Group
Vivian Cervantes investorrelations@heartsciences.com
HeartSciences (NASDAQ:HSCSW)
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HeartSciences (NASDAQ:HSCSW)
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