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

Core Viewpoint - Heart Test Laboratories, Inc. (HeartSciences) is making significant advancements in AI-powered ECG technology aimed at improving heart disease detection and is on track for regulatory submissions in 2025 [1][10]. Financial Overview - For Q1 FY2025, HeartSciences reported no revenues, with cash and cash equivalents at approximately $4.3 million and shareholders' equity at approximately $5.9 million [11]. - The company strengthened its balance sheet post-quarter by securing $1.9 million in non-dilutive financing and extending a $500,000 loan note to September 2025 [3][11]. Product Development - The MyoVista Insights AI-ECG algorithm cloud-platform is progressing, with Phase 1 completion expected by the end of 2024, and prevalidation work on a low ejection fraction algorithm set to begin soon [4][5]. - The FDA 510(k) submission for the MyoVista® wavECG™ device is on track for Q1 2025, with hardware and software issues resolved and final validation studies anticipated to follow a successful pre-submission meeting [6]. Innovation and Market Position - HeartSciences is developing both cloud and device-based AI-ECG solutions, which will enhance heart disease detection across various healthcare settings [2]. - The company has received positive feedback on its MyoVista Insights platform and is actively engaging with key opinion leaders to bolster commercialization efforts [10]. Intellectual Property and Recognition - HeartSciences has expanded its intellectual property portfolio with new patents, including a notice of allowance for detecting left and right ventricular dysfunction using deep learning [9]. - The MyoVista® wavECG™ device was selected for demonstration at the United Nations General Assembly Digital Health Symposium, highlighting its potential to transform healthcare [8].