• Exceptional results from EchoSolv HF validation study at Mayo Clinic, meeting primary endpoint
• Formal FDA 510(k) submission for EchoSolv HF completed, clearance expected in coming months
• Continued uptake of EchoSolv AS across US hospital networks

Echoiq Ltd reported a defining quarter as it transitioned from clinical validation into regulatory execution and commercial readiness for its EchoSolv products in the US healthcare market. The company completed independent clinical validation of its EchoSolv HF software through the Mayo Clinic Platform's Validate program, delivering exceptional results that exceeded expectations. The study found EchoSolv HF achieved 99.5% sensitivity and 91.0% specificity in detecting heart failure across a large, independent dataset of 17,000 echocardiograms. This marked the final clinical requirement ahead of Echoiq's formal FDA 510(k) submission for EchoSolv HF, which was completed in December 2025. Clearance of EchoSolv HF by the FDA would unlock a significant addressable market opportunity, as heart failure is the leading cause of hospitalisation and accounts for 17% of US healthcare expenditure. The company also reported continued uptake of its EchoSolv AS platform across US hospital networks through integrations, beta testing and commercial negotiations. Echoiq further strengthened its US clinical and strategic footprint through the appointment of leading cardiologists Dr Philippe Genereux and Dr Asif Ali as strategic advisors. Looking ahead, the company remains focused on securing FDA clearance for EchoSolv HF, advancing reimbursement, driving adoption of both EchoSolv platforms in the US, and exploring expansion into international markets.

Looking ahead to H2 FY2026, Echoiq Ltd remains focused on securing FDA clearance for EchoSolv HF, advancing a reimbursement strategy, driving adoption of both EchoSolv platforms in the US, and exploring expansion into international markets such as the European Union.