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HeartSciences Advances AI-ECG Technology for Early Heart Disease Detection

• HeartSciences is developing cloud and device-based AI-ECG solutions for versatile heart disease detection across healthcare settings. • The MyoVista Insights Platform, featuring an LVEF algorithm licensed from Mount Sinai, targets FDA submission in the second half of 2025. • FDA 510(k) submission for the MyoVista® wavECG™ device remains on track for the first calendar quarter of 2025. • Recent patents granted for detection of ventricular dysfunction using deep learning and MyoVista Wavelet Technology expand HeartSciences' IP.

Heart Test Laboratories, Inc., doing business as HeartSciences, is making significant strides in the development of AI-powered medical technology aimed at transforming ECGs/EKGs for earlier detection of heart disease. The company reported its first quarter fiscal 2025 financial results and provided a business update, highlighting progress in both cloud and device-based AI-ECG solutions.

MyoVista Insights Platform

The MyoVista Insights AI-ECG algorithm cloud-platform is advancing towards completion of its Phase 1 version by the end of 2024. Pre-validation work is set to begin on the first cloud-based algorithm, designed to detect low ejection fraction (LVEF ≤ 40), which is licensed from Icahn School of Medicine at Mount Sinai. Pending successful pre-validation, FDA validation studies using retrospective data are planned. The company is targeting an FDA submission for the software-based medical device in the second half of calendar year 2025.

MyoVista® wavECG™ Device

HeartSciences remains on track for an FDA 510(k) submission for its MyoVista® wavECG™ device in the first calendar quarter of 2025. Hardware and software issues are believed to be resolved, and work on the updated age-adjusted algorithm is nearing completion. A final FDA pre-submission meeting is planned to finalize validation study reporting processes related to the device's category outputs. Patient recruitment and core-lab work for the validation study have already been completed, with final FDA algorithm validation expected to follow a satisfactory pre-submission meeting.

Intellectual Property and Other Highlights

HeartSciences has expanded its intellectual property portfolio with new patents, including a notice of allowance from the United States Patent and Trademark Office for the detection of left ventricular (LV) and/or right ventricular (RV) dysfunction using deep learning. Additionally, the Indian Patent Office granted a patent for the company's MyoVista Wavelet Technology.
HeartSciences was selected to demonstrate MyoVista® wavECG™ at the United Nations General Assembly Digital Health Symposium in late September, showcasing its potential to transform healthcare. This follows expansion of their key opinion leader network outside the U.S. and positive feedback from real-world clinical use of MyoVista® wavECG™ devices in Europe.

Financial Position

As of July 31, 2024, HeartSciences reported cash and cash equivalents of $4.3 million and shareholders’ equity of $5.9 million. Subsequent to the quarter's end, the company extended its cash runway by securing $1.9 million in net proceeds through non-dilutive financing and extending a $500,000 loan note to September 2025.
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Reference News

[1]
HeartSciences Provides Business Update and Reports First Quarter Fiscal 2025 Financial Results
globenewswire.com · Sep 12, 2024

HeartSciences reported Q1 FY2025 financial results with $4.3M in cash and $5.9M in equity, and secured $1.9M in non-dilu...

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