HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis

Rhea-AI Summary

HeartSciences (HSCS) has received FDA Breakthrough Device designation for its AI-powered ECG algorithm designed to detect aortic stenosis. The algorithm, accessible through MyoVista Insights cloud platform, can identify moderate-to-severe aortic stenosis up to 24 months before confirmatory echocardiography. Developed using convolutional neural network deep learning and trained on 120,000+ ECG records, the technology integrates directly with hospital EHR systems without requiring additional hardware. The solution aims to address the critical need for early detection of aortic stenosis, a serious heart valve disease that often progresses silently and can lead to life-threatening outcomes if left untreated. The algorithm offers real-time and retrospective analysis capabilities using existing ECG data and promises expanded access to early diagnosis, particularly in underserved areas.

Positive

• FDA Breakthrough Device designation received for the aortic stenosis ECG algorithm
• Algorithm can detect aortic stenosis up to 24 months before confirmatory echocardiography
• Technology integrates directly with hospital EHR systems requiring no additional hardware
• Large training dataset of over 120,000 ECG records enhances algorithm reliability
• Expands access to early diagnosis, especially in underserved areas

Negative

• Product still requires FDA clearance before commercialization
• Technology limited to detecting moderate-to-severe cases of aortic stenosis

Insights

Medical Technology Analyst

FDA Breakthrough status for HeartSciences' AI-ECG algorithm significantly advances their path to market for early aortic stenosis detection.

This FDA Breakthrough Device designation represents a significant regulatory milestone for HeartSciences' aortic stenosis detection algorithm. The designation confirms the technology addresses a serious condition with substantial advantages over existing options and accelerates the regulatory pathway, potentially reducing time-to-market by months.

The technology's key differentiator is its ability to detect moderate-to-severe aortic stenosis up to 24 months before confirmatory echocardiography, with diagnostic accuracy improving as disease progresses. This early detection window is critical for intervention before irreversible cardiac damage occurs.

HeartSciences' implementation approach is strategically sound - the cloud-based MyoVista Insights platform integrates directly with hospital EHR systems without requiring additional hardware investments. This frictionless deployment model significantly lowers adoption barriers compared to standalone devices requiring capital expenditure.

The algorithm's development using convolutional neural networks trained on over 120,000 ECG records demonstrates robust machine learning methodology. The association with Mount Sinai adds scientific credibility. However, the press release doesn't specify sensitivity/specificity metrics or compare performance to current diagnostic standards.

For a small-cap company like HeartSciences, this designation enhances visibility with potential healthcare system customers and validates their AI approach. While commercialization timelines remain uncertain, this designation establishes a clearer regulatory pathway and potentially enables premium pricing upon market entry due to the unique capabilities and clinical advantages of early detection.

Cardiology Specialist

AI-ECG algorithm for early aortic stenosis detection addresses critical diagnostic gap with potential to transform cardiovascular care pathways.

Aortic stenosis represents a perfect target for AI-assisted detection technology. As a progressive valve disease, AS often remains clinically silent until advanced stages, when treatment options become limited and outcomes worsen. The current diagnostic pathway typically requires symptoms to trigger echocardiographic evaluation, creating a dangerous detection gap.

The clinical significance of a 24-month earlier detection window cannot be overstated. This extended timeframe enables intervention during the optimal therapeutic window when valve replacement provides maximum benefit. For context, moderate-to-severe AS has a mortality rate exceeding 50% within 2 years if left untreated after symptom onset.

The integration with standard ECG workflow addresses a fundamental healthcare challenge - identifying high-risk patients from routine diagnostic procedures. By leveraging existing ECG data without requiring specialized cardiac imaging, this technology could dramatically expand early detection, particularly in primary care settings where valve disease often goes unrecognized.

The algorithm's ability to analyze retrospective ECG data presents an unprecedented opportunity for systematic review of existing patient records to identify previously missed cases. This could enable proactive outreach to at-risk patients who may be progressing toward symptomatic disease.

From a healthcare delivery perspective, this approach aligns with value-based care models by facilitating earlier intervention, potentially reducing emergency presentations of heart failure and their associated costs while improving quality of life outcomes through timely valve replacement or repair procedures.

Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems

Southlake, TX, June 04, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”) powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Device designation for its Aortic Stenosis (“AS”) ECG algorithm.

Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and leading to severe, life-threatening outcomes if left undetected. Early symptoms are frequently vague or absent, resulting in delayed diagnosis and treatment. If unrecognized, AS can cause irreversible myocardial damage and significant deterioration in cardiac function.

The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, the algorithm will be accessible through HeartSciences' MyoVista Insights™ cloud-based platform which would directly integrate with hospital electronic health record (“EHR") systems, requiring no additional hardware or testing. This technology provides several key clinical advantages:

• Detection in asymptomatic or under-evaluated patients who may not yet show signs of AS.
• Real-time or retrospective analysis using existing ECG data already captured during routine care.
• Expanded access to early diagnosis, especially in underserved areas lacking specialized cardiac imaging or providers.

The algorithm was developed using advanced convolutional neural network (CNN) deep learning techniques and trained on more than 120,000 ECG records. In performance evaluations, it demonstrated the ability to detect aortic stenosis up to 24 months prior to confirmatory echocardiography, with diagnostic accuracy (AUROC) increasing as the disease progressed.

This breakthrough gives clinicians the ability to identify aortic valve disease earlier in its course, allowing for timely interventions and improved patient outcomes. The AI-ECG algorithm was developed at the Icahn School of Medicine at Mount Sinai by Dr. Akhil Valid.

"Receiving FDA Breakthrough Device Designation marks another significant milestone for HeartSciences," said Andrew Simpson, CEO of HeartSciences. "By combining the widespread accessibility of ECGs with the power of deep learning, our aortic stenosis algorithm has the potential to transform how this serious and often silent disease is detected—leading to earlier referrals, better treatment pathways, and ultimately, improved lives."

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 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
Phone: +1-682-244-2578 Ext. 2024
Email: info@heartsciences.com

FAQ

What is the significance of FDA Breakthrough Device designation for HeartSciences (HSCS) aortic stenosis algorithm?

The designation recognizes the algorithm's potential to transform aortic stenosis detection, enabling earlier diagnosis and treatment of this serious heart condition through AI-powered ECG analysis.

How does HeartSciences (HSCS) MyoVista Insights AI-ECG algorithm work?

The algorithm uses convolutional neural network deep learning, trained on 120,000+ ECG records, to detect moderate-to-severe aortic stenosis up to 24 months before confirmation through echocardiography.

What are the key advantages of HeartSciences (HSCS) aortic stenosis detection system?

The system integrates directly with hospital EHR systems, requires no additional hardware, provides real-time analysis, and enables early detection in asymptomatic patients, particularly benefiting underserved areas.

When will HeartSciences (HSCS) MyoVista Insights algorithm be available for use?

The algorithm still requires FDA clearance before it can be commercially available, though it has received Breakthrough Device designation.

How accurate is HeartSciences (HSCS) aortic stenosis detection algorithm?

The algorithm's diagnostic accuracy (AUROC) increases as the disease progresses, with capability to detect aortic stenosis up to 24 months before confirmatory echocardiography.