HeartSciences Provides Business Update and Reports First Quarter of Fiscal 2026 Financial Results

Core Insights - HeartSciences Inc. reported significant advancements in the first quarter of fiscal 2026, including the FDA Breakthrough Device Designation and the launch of MyoVista Insights, an AI-powered ECG management platform [2][5][8] Financial Performance - For FQ1 2026, HeartSciences reported no meaningful revenue, with approximately $2.8 million in cash and cash equivalents and $3.1 million in shareholders' equity as of July 31, 2025 [9][10] - The company raised an additional $0.8 million through a Reg A+ offering and converted $0.7 million of debt into equity, enhancing its financial position [9] Product Development - MyoVista Insights is a cloud-native software platform aimed at modernizing ECG management systems and facilitating access to AI-ECG algorithms without the need for new ECG devices [6][11] - The platform is designed to integrate with existing ECG hardware and clinical workflows, with CPT reimbursement codes approved by CMS to support AI-ECG adoption [6] - The MyoVista wavECG device is set to host AI-ECG algorithms and is on track for FDA 510(k) submission within the current calendar year [6] Regulatory and Market Position - The FDA granted Breakthrough Device designation for HeartSciences' aortic stenosis ECG algorithm, validating the company's AI-ECG opportunity [5][8] - The company plans to update its algorithms in response to new guidelines from the American Society of Echocardiography, which may enhance its commercial value [6] Intellectual Property - HeartSciences expanded its intellectual property portfolio, holding 44 granted patents worldwide, including a key U.S. patent for estimating echocardiographic parameters via ECG [7]