HeartSciences Q3 FY2025 no revenue, cash $2.6M; FDA submission for MyoVista device expected H1 2025

HeartSciences Inc.

2025-Q3 EPS reported -$7.46 vs consensus -$1.94 ▼ miss (-284.9%)

No revenue for Q3 FY2025; cash and equivalents $2.6M, shareholders' equity $1.8M as of Jan 31, 2025.
Final pre-submission meeting with FDA for MyoVista wavECG device completed Feb 2025; clinical validation within weeks, FDA submission targeted H1 2025.
MyoVista Insights cloud platform Phase 1 completed Dec 2024; Phase 2 (AI-ECG reporting, subject to FDA clearance) targets submission H2 2025.
Pre-validation work commenced with Rutgers on low ejection fraction algorithm licensed from Mount Sinai; aim for FDA submission H2 2025.
CMS 2025 OPPS final rule includes AI-ECG reimbursement effective Jan 2025, enabling reimbursement upon commercial launch.

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