HeartSciences Provides Business Update and Reports Third Quarter Fiscal 2025 Financial Results

Rhea-AI Summary

HeartSciences (HSCS) reported Q3 FY2025 financial results and business updates, highlighting significant progress in AI-powered ECG technology. The company reported no revenues for Q3 FY2025, with cash and cash equivalents of $2.6 million and shareholders' equity of $1.8 million as of January 31, 2025.

Key developments include:

• Final pre-submission meeting with FDA for MyoVista wavECG device in February 2025, with expected FDA clearance submission in H1 2025
• Successful completion of Phase 1 MyoVista Insights cloud-native platform in December 2024
• Pre-validation work completed with Rutgers for low ejection fraction algorithm
• CMS 2025 OPPS final rule inclusion enabling reimbursement upon commercial launch

The company's strategy focuses on modernizing ECG technology through AI-enhanced hardware and software solutions, positioning itself as the only company building next-gen ECG device hardware, device-agnostic cloud-native software, and AI-ECG algorithms.

Positive

• CMS reimbursement approval at higher rates than conventional ECG
• Successful completion of Phase 1 MyoVista Insights platform
• Final FDA pre-submission meeting completed for MyoVista wavECG
• Strategic positioning as the only company offering comprehensive AI-ECG solutions

Negative

• No revenue generated in Q3 FY2025
• cash position of $2.6 million
• FDA clearance still pending for key products
• Multiple regulatory approvals still required for full implementation

Insights

Financial Analyst

HeartSciences' Q3 FY2025 report reveals significant regulatory progress but continued zero revenue operations. With $2.6 million cash on hand and $1.8 million in shareholders' equity as of January 31, 2025, the company's runway requires close monitoring given ongoing R&D expenses.

The company is making measured progress toward commercialization with several positive developments: 1) Final pre-submission FDA meeting for MyoVista wavECG device completed in February 2025, with clearance submission expected in H1 2025; 2) Completion of Phase 1 for the cloud-native MyoVista Insights platform; 3) Successful pre-validation work with Rutgers on their low ejection fraction algorithm; and 4) Inclusion in the CMS 2025 OPPS final rule, establishing reimbursement pathways upon launch.

HeartSciences' three-phase strategy for MyoVista Insights is noteworthy—beginning with device-agnostic ECG reporting capabilities that don't require regulatory clearance, followed by AI-ECG algorithm integration (pending regulatory approval in H2 2025), and ultimately evolving into a full ECG management system. Their "app store" approach to algorithms could significantly reduce development costs and accelerate market penetration.

The reimbursement clarity from CMS at rates "significantly higher than conventional ECG" represents a important commercial milestone. However, investors should note the company still faces multiple regulatory hurdles before generating revenue, with submissions planned throughout 2025 but no guaranteed timelines for approval or commercialization.

Medical Technology Expert

HeartSciences is positioning itself at the intersection of several important healthcare technology trends with its AI-enhanced ECG approach. Their strategy addresses significant clinical needs—ECGs are among the most common medical tests worldwide but rely on decades-old technology with diagnostic capabilities for certain conditions.

The company's three-pronged approach is technically sound: 1) Developing next-gen ECG hardware (MyoVista wavECG); 2) Creating a device-agnostic cloud platform (MyoVista Insights); and 3) Building an algorithm marketplace similar to an app store. This comprehensive strategy differentiates them from competitors focusing solely on algorithms or hardware.

From a technical standpoint, their cloud-native architecture on AWS offers significant advantages over legacy ECG management systems, particularly in interoperability, cybersecurity, and cost efficiency. The company is correctly identifying that hospital systems are struggling with outdated on-premise server-based ECG management solutions that are inflexible and expensive.

Their algorithm validation work with established institutions like Rutgers and Mount Sinai adds credibility to their technical approach. The low ejection fraction (LVEF ≤40) algorithm addresses a critical diagnostic gap, as reduced ejection fraction often goes undetected until advanced stages despite being a key indicator of heart failure.

The phased development approach is pragmatic—beginning with non-regulated reporting capabilities allows for market entry while navigating the regulatory pathway for AI components. However, the crowded healthcare AI space and hospital systems' typically slow technology adoption cycles remain significant challenges despite the promising technology foundation.

Southlake, TX, March 13, 2025 (GLOBE NEWSWIRE) -- 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 third quarter fiscal 2025 ended January 31, 2025 and provided a business update.

Third Fiscal Quarter 2025 Highlights:

During the third quarter of fiscal year 2025 (“Q3 FY2025”) and to date in 2025, HeartSciences has seen material progress towards FDA submissions of our products and there have been significant positive developments in the AI-ECG field. A summary of the current status and key business highlights for Q3 FY2025 include:

• AI-ECG presents a generational opportunity to modernize the ECG industry, one of the most ubiquitous medical tests in the world. ECGs are generally decades-old devices, outdated technology and rely on legacy reporting and managements systems. By enhancing both hardware and software, HeartSciences enables earlier and more accurate detection of heart disease, bridging a critical diagnostic gap in frontline healthcare.

• HeartSciences is the only company building next-gen ECG device hardware, device agnostic cloud-native software and AI-ECG algorithms. Our versatility will enable us to deliver AI-ECG solutions across a variety of healthcare settings, ranging from large hospital systems to simple nurse-led mobile testing services.

• The final pre-submission meeting for the MyoVista® wavECG^TM device took place with the FDA in February 2025 and we expect to finalize the FDA study clinical validation in a few weeks.  Assuming this is successful, we anticipate submiting the device for FDA clearance within the first half of calendar 2025.

• The Company is in active discussions for MyoVista® Insights^TM to be implemented in test sites during 2025, which followed on-scheduled completion of Phase 1, in December 2024. MyoVista Insights is a cloud-native, cybersecure modern technology stack operating on a device agnostic basis for the millions of ECGs in place today. It is intended to radically upgrade ECG reporting and does not require regulatory clearance (as it is reporting based).

• Phase 2, which is subject to regulatory clearance, will add AI-ECG reporting. The Company has developed the system to provide both proprietary and third-party AI-ECG algorithms with the intention to function 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 submission in the second half of calendar 2025 along with the first cloud-based algorithm (discussed below).

• Thereafter in Phase 3, HeartSciences intends for MyoVista Insights to serve as an ECG management system, a market valued in the billions of dollars. 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

• In February, 2025 we successfully undertook pre-validation work with Rutgers Robert Wood Johnson Hospital System on the low ejection fraction (LVEF ≤ 40) algorithm licensed from Icahn School of Medicine at Mount Sinai, New York (Mount Sinai). We expect that this will be the first algorithm for FDA validation alongside the MyoVista Insights platform. The Company will now undertake final work and perform FDA validation studies using retrospective data with the aim of FDA submission in the second half of calendar 2025.  

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 were included in the CMS 2025 OPPS final rule, which became effective in January 2025. This enables appropriate reimbursement immediately upon commercial launch and is a significant milestone in AI-ECG being widely adopted.

Management Commentary

“This quarter has seen considerable across the board progress at HeartSciences. Following the meeting with the FDA in February, clinical validation for the MyoVista wavECG device is expected within weeks and, assuming it is successful, FDA submission would follow soon after in the first half of the year.” said Andrew Simpson, CEO of HeartSciences.

“We successfully completed Phase 1 MyoVista Insights cloud-native platform on schedule, utilizing  millions of dollars of investment. We undertook pre-validation of the low ejection fraction algorithm with Rutgers Robert Wood Johnson Hospital System. This is the first of severa algorithms licensed from the Icahn School of Medicine at Mount Sinai which we expect will be applied through regulatory clearance. It reinforces our belief that collaboration with Mount Sinai is enormously valuable.”

“Feedback on MyoVista Insights cloud-native platform has been excellent, and we are in active discussion 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 allowing patients and health systems environments to realize their significant benefits.”

“Finally, and importantly, CMS has already established reimbursement for AI-ECG at a rate significantly higher than that of conventional ECG. We believe this further validates the clinical value of AI-ECG and highlights the significant commercial opportunity for one of the most widely used medical tests worldwide, with millions of ECGs are performed every week.” concluded Mr. Simpson.

Third Quarter Fiscal 2025 Financial Results

There were no revenues during Q3 FY2025. As of January 31, 2025, cash and cash equivalents were approximately $2.6 million and shareholders’ equity was approximately $1.8 million. Complete financial results have been filed in the Company’s Quarterly Report Report for the fiscal quarter ended January 31, 2025 on Form 10-Q with the U.S. Securities and Exchange Commission and is available on the Company’s website https://www.heartsciences.com

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, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2025, filed with the SEC on March 13, 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.

Investor Relations:

Integrous Communications
Mark Komonoski
Partner
Phone: 877-255-8483
Email: mkomonoski@integcom.us 

Media Contact:

HeartSciences
Gene Gephart
+1-682-244-2578 Ext. 2024
info@heartsciences.com

FAQ

What is the current cash position of HeartSciences (HSCS) as of Q3 FY2025?

HeartSciences had approximately $2.6 million in cash and cash equivalents as of January 31, 2025, with shareholders' equity of approximately $1.8 million.

When does HeartSciences (HSCS) expect to submit MyoVista wavECG for FDA clearance?

HeartSciences anticipates submitting the MyoVista wavECG device for FDA clearance within the first half of calendar 2025, following successful clinical validation.

What is the significance of HeartSciences' (HSCS) inclusion in the CMS 2025 OPPS final rule?

The inclusion enables appropriate reimbursement immediately upon commercial launch, at a rate significantly higher than conventional ECG, validating AI-ECG's clinical value.

What are the three phases of HeartSciences' (HSCS) MyoVista Insights platform development?

Phase 1: Cloud-native ECG reporting (completed Dec 2024), Phase 2: AI-ECG algorithm integration (planned H2 2025), Phase 3: Full ECG management system implementation.

What is HeartSciences' (HSCS) strategy for AI-ECG algorithm deployment?

The company plans to create an app store-like platform for AI-ECG algorithms, reducing costs and regulatory burden while enabling quick deployment of both proprietary and third-party algorithms.