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

Core Insights - HeartSciences Inc. is focused on transforming ECG technology through AI to enhance early detection of heart disease and has reported significant progress in its business and technology developments for Q2 FY2025 [1][2] Business Highlights - HeartSciences is the only company developing next-generation ECG device hardware, cloud-native software, and AI-ECG algorithms, aiming to modernize the ECG industry which relies on outdated technology [2][11] - The MyoVista Insights platform is nearing completion of Phase 1, with a focus on creating a cloud-native ECG reporting system on AWS, expected to be implemented in test sites in the first half of 2025 [3][4] - Phase 2 will introduce AI-ECG reporting and operate like an app store for AI-ECG algorithms, reducing costs and regulatory burdens [4][5] - Phase 3 aims to establish an ECG management system, targeting a multi-billion dollar market, with a focus on lower costs and improved interoperability [5] Product Development - Progress on the MyoVista® wavECG device is on track for FDA submission by the end of Q1 2025, with a pre-submission meeting planned to finalize the validation study [7] - The first cloud-based AI-ECG algorithm, focusing on low ejection fraction, is in pre-validation, with FDA validation studies anticipated to follow [6] Regulatory and Market Position - HeartSciences' AI-ECG algorithms have been included in the CMS 2025 OPPS final rule, allowing for immediate reimbursement upon commercial launch, marking a significant milestone for AI-ECG adoption [8] - The company aims to provide a versatile AI-ECG solution suitable for various healthcare settings, enhancing access to cardiac screening tools [11][13] Financial Overview - For Q2 FY2025, HeartSciences reported no revenues, with cash and cash equivalents at approximately $4.1 million and shareholders' equity at approximately $4.0 million [12]