– 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 year ended April 30, 2022.
Recent
Highlights
- Majority of the patient recruitment has taken place for the
pivotal clinical validation study of MyoVista
- Completed Initial Public Offering (IPO) with gross proceeds of
approximately $6.375 million, significantly enhancing the balance
sheet
- Listed on Nasdaq Capital Market under ticker HSCS
“The ECG is a ubiquitous, relatively low-cost,
simple and quick test; it is portable and can be performed in a
wide range of clinical settings by a non-specialist clinician or
clinical aide. Our objective is to help address one of the most
significant needs in healthcare by making an ECG a far more
valuable cardiac screening tool, particularly in frontline or
point-of-care clinical settings,” commented, Andrew Simpson, Chief
Executive Officer of HeartSciences. “Heart disease is often
referred to as the ‘silent killer’ and, according to the American
Heart Association, one in three patients are not properly diagnosed
until after a heart attack occurs and 50% of men and 64% of women
who died suddenly of coronary heart disease had no previous
symptoms. Additionally, according to the Centers for Disease
Control and Prevention (CDC), one person dies from cardiovascular
disease every 36 seconds and heart disease accounts for
approximately one in four deaths.”
“We believe that there is currently no low-cost,
front-line, medical device that is effective at screening for heart
disease. As a result, we believe that primary care physicians face
a significant challenge in determining if a patient has heart
disease. In 2012, the United States Preventive Services Task Force,
or USPSTF, conducted an evaluation of conventional ECG testing and
stated: ‘There is no good evidence that an ECG helps physicians
predict heart risks in people with no symptoms any better than
traditional considerations such as current or former smoking, blood
pressure and cholesterol levels.’ Despite the limitations of the
conventional ECG and healthcare guidance around the world that
recommends against its use for heart disease screening, in the
absence of a better alternative, the ECG remains the most commonly
used test throughout healthcare including non-cardiology settings.
In fact, it is estimated that 1.5 to 3 million ECGs are performed
worldwide every day.”
“We believe that the absence of cost-effective
front-line or primary-care-based testing has resulted in the
over-use of costly cardiology-based diagnostic tests. Consequently,
we have designed the MyoVista, a 12-lead resting
electrocardiograph device that features wavECG Technology,
plus the capabilities of a full featured conventional 12-lead
resting ECG. As a result, MyoVista is uniquely designed to help
address the current limitations and extend the clinical capability
of an ECG in detecting cardiac dysfunction. We apply AI-machine
learning to the signal processed electrical signal of the heart and
our first algorithm is designed to detect cardiac dysfunction
caused by heart disease and/or age-related cardiac
dysfunction.”
Editorial comment associated with a study involving the MyoVista
published in the Journal of American College of Cardiology
discussed recent applications of machine learning to data derived
from surface 12-lead ECGs in relation to cardiac dysfunction:
“These are some of the most significant advances in
electrocardiography since its inception, which has historically had
a limited, if any, role in the evaluation of cardiac dysfunction.
In the past, our cardiovascular community was resigned to the fact
that surface ECGs are poor indicators for cardiac dysfunction.”
1
“Based on feedback from the previous FDA De Novo
submission in late 2019 and subsequent interaction with the FDA,
multiple changes have been incorporated into the device and
associated documentation. Importantly, the majority of patients
have already been recruited for our new, pivotal clinical
validation study for our proposed FDA De Novo resubmission. The
study is expected to be a 575-patient clinical validation study. We
currently expect to resubmit for FDA De Novo clearance in the
current fiscal year, and the FDA’s De Novo classification
authorization process generally takes from five to twelve months
from the date the application is submitted.”
“Our objective is to make the MyoVista wavECG
the new standard-of-care, as an affordable and valuable frontline
test for assessing heart health,” continued Mr. Simpson. “Assuming
FDA approval, we intend to develop a direct sales force to target
hospitals, physicians’ offices, as well as large retail healthcare
organizations in the U.S. For markets outside of the U.S., such as
Europe and Latin America, we have already signed several medical
device distributors, which will be supported by a small number of
local field personnel, to service the large global market for
ECGs.”
“We are extremely proud of the progress made to
date, including multiple study publications and investor support in
completing our IPO and Nasdaq listing, which has strengthened our
balance sheet and provided us additional resources to advance our
pivotal validation study and proceed with the resubmission of the
results to the FDA for review. We remain encouraged by the market
potential for our device and look forward to providing meaningful
updates as developments unfold,” concluded Mr. Simpson.
As a development-stage company, there were no meaningful
revenues for the fiscal years 2022 and 2021. As of April 30, 2022,
cash and cash equivalents were $918,000 and in June 2022,
HeartSciences received net proceeds of $5.2 million in the IPO. The
Company continues to carefully manage its expenses to execute on
key upcoming milestones. Complete financial results have been filed
with the Securities and Exchange Commission, in the Company’s Form
10-K for the period ending April 30, 2022, which is available on
the Company’s website.
About Heart Test Laboratories, Inc.
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 by detecting cardiac dysfunction. 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
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. Additional
information about the Company is available at
www.heartsciences.com.
Important Cautions Regarding Forward Looking
Statements
This press release contains certain "forward-looking statements"
within the meaning of federal securities laws. All statements,
other than statements of historical facts, included herein are
"forward-looking statements" including, among other things,
statements about HeartSciences’ beliefs and expectations. 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.
Notes:
- Khurram Nasir, MD, MPH, MSC, Department of Cardiology, Houston
Methodist DeBakey Heart & Vascular Center, Houston, Texas, et.
al., Journal of American College of Cardiology Editorial Comment
Volume 76 Number 8 2020.
Contact:
Crescendo Communications, LLC Email: HSCS@crescendo-ir.com Tel:
(212) 671-1021
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