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HeartSciences Provides Business Update and Reports Fiscal 2025 Financial Results
Globenewswire· 2025-07-24 20:15
Core Viewpoint - HeartSciences Inc. is advancing its AI-powered ECG technology to enhance heart disease detection and aims for commercialization in 2026, pending regulatory approvals [1][6]. Fiscal 2025 and Business Highlights - The company made significant strategic advancements in fiscal year 2025, focusing on enhancing the clinical value of ECGs through AI and cloud technologies applicable in various healthcare settings [2]. - HeartSciences launched the MyoVista Insights software platform, designed to modernize ECG management and integrate with existing hospital systems, facilitating access to AI-ECG algorithms [6][7]. MyoVista Insights™ Software Platform - MyoVista Insights aims to become the first cloud-native ECG management software, targeting a multibillion-dollar market by replacing outdated systems [6]. - The platform began rollout in May 2025, with plans for a second phase alongside the FDA submission of a cloud-based algorithm for detecting reduced ejection fraction in 2026 [6]. MyoVista® wavECG™ Device - The company is nearing FDA submission for the MyoVista wavECG device, with final testing nearly complete [6]. - The device incorporates an algorithm for impaired cardiac relaxation that aligns with updated guidelines from the American Society of Echocardiography [6]. Financial Results - HeartSciences reported no significant revenue for fiscal year 2025, with approximately $1.1 million in cash and $0.2 million in shareholders' equity as of April 30, 2025 [8]. - The company raised $3.1 million in gross proceeds through a Reg A+ offering and converted $0.9 million of debt into equity, strengthening its balance sheet [11]. Regulatory and Market Developments - The Centers for Medicare & Medicaid Services approved reimbursement for AI-ECG algorithms at $128 per test, in addition to standard ECG reimbursement [6]. - The FDA granted "Breakthrough Device" designation for HeartSciences' aortic stenosis ECG algorithm, indicating significant potential in the market [6]. Intellectual Property and Partnerships - HeartSciences expanded its intellectual property portfolio, holding 44 granted patents worldwide, including a key patent for estimating echocardiographic parameters via ECG [6]. - The company is growing its institutional clinical partnerships and Scientific Advisory Board to support clinical adoption and development [6].