HeartSciences Provides Business Update and Reports Second Quarter Fiscal 2025 Financial Results
17 12월 2024 - 6:15AM
HeartSciences Inc. (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 reported financial results for the second
quarter fiscal 2025 ended October 31, 2024 and provided a business
update.
Second Fiscal Quarter 2025
Highlights:
In the run up to the close of 2024 and the
second quarter of fiscal year 2025 (“Q2 FY2025”), HeartSciences saw
across the board material progress and more positive developments
for the field of AI-ECG, its MyoVista® wavECGTM device, MyoVista®
InsightsTM cloud-native platform and first cloud-based AI-ECG
algorithms. A summary of current status and business highlights
during Q2 FY2025 include:
-
HeartSciences is the only company building next-gen ECG device
hardware, cloud-native software and AI-ECG algorithms. The ECG
industry generally uses decades-old devices, outdated technology
and legacy reporting and managements systems. AI-ECG presents a
generational opportunity to modernize the ECG industry which is one
of the most ubiquitous medical tests in the world. Our versatility
will enable us to deliver AI-ECG solutions across a wide range of
healthcare settings, from large hospital systems to simple
nurse-led mobile testing services.
-
There has been excellent progress on the MyoVista Insights
platform. Phase 1 will be completed by the end of the calendar
year. HeartSciences has invested millions of dollars in 2024 to
develop a cloud-native ECG reporting system which will run on
Amazon Web Services (AWS). MyoVista Insights is a cybersecure
modern technology stack which is intended to radically upgrade ECG
reporting. Phase 1 does not require regulatory clearance (as it is
reporting based) and the Company is in discussions for this to be
implemented in test sites in the first half of 2025.
-
Phase 2, which requires regulatory clearance, will add AI-ECG
reporting. The Company has built the system to provide both
Company-developed and third-party AI-ECG algorithms. HeartSciences
intends to operate it like an app store for AI-ECG. This will
radically reduce the cost and regulatory burden on the Company in
developing all of its own algorithms and ensure the Company can
bring a broad panel of AI-ECG algorithms to clinical practice in an
expeditious manner. HeartSciences is aiming for Phase 2 regulatory
clearance in the second half of 2025.
-
Thereafter in Phase 3, HeartSciences’ intention is for MyoVista
Insights to provide an ECG management system which is a
multi-billion dollar market. It is a necessity for all hospital
systems worldwide to have an ECG management system. Current systems
are generally dependent on decades-old IT architecture which are
on-premise, server-based, lack flexibility and are costly for
health systems. MyoVista Insights is a cloud-native application
running on AWS, built to be much lower cost and provide
considerably upgraded interoperability and cybersecurity.
-
Pre-validation work on the Company’s first cloud-based AI-ECG
algorithm, which will be a low ejection fraction (LVEF ≤ 40)
algorithm licensed from Icahn School of Medicine at Mount Sinai,
New York (Mount Sinai) is progressing. Assuming this work is
successful, FDA validation studies, expected to be conducted using
retrospective data, would follow.
-
There has been considerable progress on the MyoVista® wavECG™
device and HeartSciences remains on track for FDA submission around
the end of the first calendar quarter 2025. The Company has
requested a final pre-submission meeting with the FDA to finalize
the validation study reporting plan associated with the category
outputs of the MyoVista wavECG. Assuming the meeting is
satisfactory, final validation and FDA submission are expected to
take place expeditiously thereafter.
Other notable highlights:
-
HeartSciences’ MyoVista wavECG AI-ECG algorithm and many of the
AI-ECG algorithms that would be delivered by the MyoVista Insights
cloud platform have been included in the CMS 2025 OPPS final rule,
effective January 2025. This would enable appropriate reimbursement
immediately upon commercial launch and is a significant milestone
in AI-ECG being widely adopted.
-
HeartSciences successfully demonstrated its MyoVista® wavECG™ at
the United Nations General Assembly Digital Health Symposium after
its selection as a technology to radically transform
healthcare.
-
Launch of our new website at https://www.heartsciences.com.
Management Commentary
“We end calendar 2024 in a strong position,
having made significant progress. HeartSciences is the only Company
developing across the board ECG solutions to upgrade archaic
devices, clinical capabilities, and reporting and management
systems which are a necessity for any healthcare system
worldwide.”
“By calendar year end, our Phase 1 MyoVista
Insights cloud-native platform will be complete after millions of
dollars of investment. Feedback to date has been excellent and we
are in discussions for early deployment in test environments. Our
ultimate vision is to offer a path to modernize legacy ECG
management systems, as they are generally inflexible and costly due
to decades-old IT architecture. Instead, we will provide a
next-gen, cybersecure cloud-native system to meet the sophisticated
data driven needs of today’s health systems. Our AI-ECG marketplace
will facilitate far quicker rollout of AI-ECG and allow patients
and health systems environments to realize their significant
benefits.”
“Our MyoVista wavECG is approaching FDA
submission and will allow next-to-patient, immediate access to
AI-ECG results which is suitable for many frontline healthcare
settings and territories around the world. Our versatility will
enable us to deliver AI-ECG solutions across a wide range of
healthcare settings, from large hospital systems to simple
nurse-led mobile testing services.” concluded Mr. Simpson.
Second Quarter Fiscal 2025 Financial
Results
There were no revenues during Q2 FY2025. As of
October 31, 2024, cash and cash equivalents were approximately $4.1
million and shareholders’ equity was approximately $4.0 million.
Complete financial results have been filed in the Company’s
Quarterly Report on Form 10-Q with the U.S. Securities and Exchange
Commission and is available on the Company’s website.
About HeartSciences
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 intends to provide these AI-ECG algorithms
on a device agnostic cloud-based solution as well as a low-cost ECG
hardware platform. Working with clinical experts, HeartSciences
ensures that all solutions are designed to work within existing
clinical care pathways, making it easier for clinicians to use
AI-ECG technology to improve their patient's care and lead to
better outcomes. 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://www.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, HeartSciences’ Quarterly
Report on Form 10-Q for the fiscal quarter ended October 31, 2024,
filed with the SEC on December 16, 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:
HeartSciencesGene Gephart+1-682-244-2578 Ext.
2024info@heartsciences.com
InvestorsGilmartin GroupVivian
Cervantesinvestorrelations@heartsciences.com
HeartSciences (NASDAQ:HSCSW)
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