Company Summary: HeartSciences Inc.

Business Focus:
HeartSciences Inc. is a medical technology company dedicated to enhancing ECG (electrocardiogram) capabilities through AI-based algorithms (AI-ECG). The company aims to expand the clinical usefulness of standard ECGs, enabling early detection of a broader range of heart diseases, including cardiac dysfunction and diastolic dysfunction, which are often missed by conventional ECGs.

Core Technologies and Products:

• MyoVista wav ECG: A resting 12-lead ECG device integrating proprietary AI-ECG algorithms to detect cardiac dysfunction, specifically impairments in cardiac relaxation caused by heart disease or age-related changes. It combines traditional ECG analysis (including licensing the Glasgow Algorithm) with AI-driven diagnostic insights.
• MyoVista Insights Cloud Platform: A cloud-based, ECG device-agnostic platform designed to host multiple AI-ECG algorithms (both developed internally and licensed from third parties like Mount Sinai), offering clinical reporting and storage. It enables integration into existing clinical workflows and facilitates faster deployment of new algorithms.
• AI-ECG Algorithms: Designed to provide diagnostic information traditionally obtained through imaging, aiding detection of conditions like low ejection fraction (systolic dysfunction) and impaired cardiac relaxation (diastolic dysfunction). The first FDA-regulated algorithm licensed from Mount Sinai is for low ejection fraction detection.

Business Model and Strategy:

• Initial revenue plans include a "razor-razorblade" model with device sales, premium proprietary electrodes, and recurring revenue from AI-ECG algorithm subscriptions via the cloud platform.
• The platform enables easy deployment of third-party algorithms, expanding treatment indications and reducing R&D costs.
• The primary target markets are front-line healthcare settings in the U.S. and globally, including cardiology, primary care, retail clinics, hospitals, emergency departments, and specialty clinics.

Regulatory Status:

• The MyoVista wav ECG is classified as a Class II medical device in the U.S. and has received FDA clearances via the 510(k) pathway for algorithms related to hypertrophic cardiomyopathy and low ejection fraction.
• They are preparing for FDA submission of the MyoVista Insights Cloud Platform and additional algorithms in 2025 and 2026.
• In Europe, the company currently holds a CE Mark under the older MDD framework, which lapsed in February 2022, and is working to establish compliance under the EU MDR.

Partnerships and Licensing:

• In September 2023, HeartSciences licensed multiple AI-ECG algorithms from Icahn School of Medicine at Mount Sinai, including a breakthrough designation for an aortic stenosis algorithm from FDA.
• Also has licensing agreements with The University of Glasgow for the Glasgow Algorithm.

Employees and Clients:

• As of July 23, 2025, the company has 15 full-time employees (including CEO) and 9 independent contractors.
• It has signed two initial early adopter customers for its cloud platform, enabling integration into clinical workflows.

Financials and Market Data:

• As of July 23, 2025, the company has 1,934,280 shares of common stock outstanding.
• The estimated market value of the voting stock held by non-affiliates is approximately $5.4 million, based on a closing price of $2.94 as of the last business day of the most recent second fiscal quarter ending October 31, 2024.
• The company has incurred significant operating losses, with net losses of approximately $8.8 million for Fiscal 2025 and $6.6 million for Fiscal 2024.
• It has an accumulated deficit of approximately $76.1 million as of April 30, 2025.
• The company’s operational infrastructure and revenue generation are still in development, with a focus on FDA clearances and future sales expansion.