HeartSciences Provides Business Update and Reports Fiscal 2024 Financial Results

Core Viewpoint - Heart Test Laboratories, Inc. (d/b/a HeartSciences) is advancing its AI-powered medical technology for ECGs/EKGs, aiming to enhance early detection of heart disease and improve healthcare outcomes through innovative solutions [1][36]. Business Developments - The company has fundamentally transformed its business model, positioning itself to offer both cloud-based and device-based AI-ECG solutions across various healthcare settings [3][34]. - The MyoVista Insights cloud-platform is being developed with a phased rollout plan, targeting FDA clearance alongside its first cloud-based AI-ECG algorithm [4][19]. - The company is finalizing adjustments to its device-based AI-ECG algorithm, leveraging extensive patient data from Mount Sinai to enhance its clinical utility [7][12]. Financial Overview - As of April 30, 2024, the company reported cash and cash equivalents of approximately $5.8 million and shareholders' equity of about $7.3 million, indicating a strong balance sheet [10][29]. - During fiscal year 2024, the company raised $10.3 million in net proceeds from common stock sales and converted $1.1 million of debt to equity [29]. Regulatory and Clinical Progress - The company is preparing for an FDA validation study for the LVEF algorithm, utilizing retrospective data to streamline costs and timelines [5][23]. - The MyoVista wavECG device is on track for FDA submission in early 2025, with final system testing underway [15][22]. - The company has established a robust patent portfolio, including new patents for AI-ECG applications in assessing heart function [9][28]. Market Position and Future Outlook - HeartSciences aims to capitalize on a projected $25 billion annual market for AI-ECG solutions, focusing on bridging the diagnostic gap for early heart disease detection [33]. - The MyoVista Insights platform is designed to be device agnostic, facilitating a marketplace for AI-ECG algorithms and enhancing clinical access to these technologies [11][34]. - The company has received positive feedback from early clinical use of its devices in Europe and has been selected to showcase its technology at significant health symposiums [26][34].