HeartSciences Provides Business Update and Reports First Quarter Fiscal 2023 Financial Results
September 13 2022 - 8:00AM
Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ:
HSCS; HSCSW) (“HeartSciences” or the “Company”), a medical
technology company focused on applying innovative AI-based
technology to an ECG (also known as an EKG) to significantly expand
and improve an ECG’s clinical usefulness by detecting cardiac
dysfunction, today provided a business update and reported
financial results for the fiscal first quarter ended July 31,
2022.Andrew Simpson, Chief Executive Officer of HeartSciences,
commented, “We are nearing completion of patient recruitment for
the FDA pivotal clinical validation study of the MyoVista® wavECG™
device with over 500 patients recruited out of an overall target of
550 patients. We expect to report study results following its
completion. Assuming a successful outcome, we remain on track
to resubmit for FDA De Novo clearance in the current fiscal year.”
“We are seeking to address one of the most significant needs in
healthcare by making an ECG a far more valuable cardiac screening
tool. The growing body of published ECG research demonstrates that
ECGs can have far greater clinical value. Our first device, the
MyoVista, leverages AI machine learning to detect cardiac
dysfunction that cannot be diagnosed by current conventional ECGs
and its technology has been the subject of several published
studies in elite cardiology journals. As a result, we believe we
are positioned at the forefront of what is expected to be a new era
for ECGs.”
“The Company has benefited from approximately $60 million of
investment to date and has built an extensive intellectual property
portfolio. We intend to continue to add patents to further
strengthen our long-term IP protection as we move towards
commercialization. Ultimately, our goal is to make MyoVista the new
standard of care, particularly in the frontline or point-of-care
clinical setting. In fact, according to Allied Market
Research, the global ECG market was valued at $8.3 billion in 2020
and is projected to reach $18.4 billion by 2030.”
“Furthermore, during the first quarter of fiscal 2023, we
completed our initial public offering with gross proceeds of
approximately $6.375 million. The IPO significantly enhanced
our balance sheet provides us with sufficient expected cash runway
to execute on key upcoming milestones, including completing our FDA
pivotal study and resubmission for FDA De Novo clearance.”
As a development-stage company, there were no meaningful
revenues for the first quarter of 2023. As of July 31, 2022, cash
and cash equivalents were $4.3 million. The Company continues to
carefully manage its expenses and believes it has sufficient
capital to support operations beyond resubmission for FDA De Novo
clearance. Complete financial results have been filed with the
Securities and Exchange Commission, in the Company’s Form 10-Q for
the period ending July 31, 2022, which is available on the
Company’s website.
About HeartSciences
Heart Test Laboratories, Inc. d/b/a HeartSciences is 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. The Company’s objective is to make 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 a form of cardiac dysfunction
called left ventricular diastolic dysfunction (LVDD), which has
traditionally only been available through the use of cardiac
imaging. LVDD is associated with almost all forms and
co-morbidities of heart disease including hypertension, diabetes,
valvular disease, ischemia, and reduced systolic function among
others.
The MyoVista Device additionally provides all the information
and capabilities of a full-featured conventional resting 12-lead
ECG within the same test and follows the same clinical AHA/IEC lead
placement protocol.
For more information, please visit:
https://www.heartsciences.com
For investor and media inquiries, please contact:
Investor Relations:
Crescendo Communications, LLC
Phone: (212) 671-1021
Email: HSCS@crescendo-ir.com
Company: Gene Gephart Phone: +1-737-414-9213
(US) Email: investorrelations@heartsciences.com
Safe Harbor Statement
This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. 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’ filings with the U.S. Securities and Exchange
Commission 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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