• Clinical validation successfully completed with Mayo Clinic Platform's Validate program
• EchoSolv HF validation met the primary endpoint, delivering performance exceeding company expectations
• Study results show 99.5% sensitivity and 91.0% specificity in detecting heart failure

Echo IQ Limited (ASX: EIQ) has completed a clinical validation study for its heart failure clinical decision support software, EchoSolv HF, in collaboration with the Mayo Clinic Platform (MCP), a division of the Mayo Clinic. The MCP Validate program is a unique in-market AI evaluation program which generates an independent and objective report on accuracy, efficacy and susceptibility to bias for AI-based decision software. The clinical validation was designed to evaluate the EchoSolv HF model's ability to detect heart failure on an independent dataset of ~17,000 individual echocardiogram studies. In a major milestone, the primary endpoint of the clinical validation has been met, with results exceeding expectations. The study results show that EchoSolv HF demonstrated outstanding performance in identifying patients with heart failure, achieving a sensitivity of 99.5%. Likewise, the model was accurate in identifying patients that did not have heart failure, achieving a specificity of 91.0%. Completion of the clinical validation marks the final clinical requirement prior to a formal submission for clearance by the US Food & Drug Administration (FDA). Echo IQ is now in the process of completing its formal submission to advance the clearance of EchoSolv HF via the FDA's 510(k) regulatory pathway, with the submission expected to be lodged in the coming weeks. FDA clearance of the solution would allow for EchoSolv HF to be marketed to and used by healthcare professionals in the USA as a clinical decision support software to aid in the detection of heart failure, which is the leading cause for rehospitalisation in the US and accounts for 17% of all healthcare expenditure in the country, with a total market size of US$60Bn.

Upon potential FDA clearance of the solution, the Company intends to leverage its existing footprint in the US market to drive uptake of EchoSolv HF.

The independent confirmation of the EchoSolv HF model's accuracy and reliability through the Mayo Clinic Platform's Validate program have exceeded internal expectations and provides strong objective evidence supporting the clinical utility of EchoSolv HF in real-world settings, particularly compared to existing diagnostic tools being utilised across the US. Gaining FDA clearance will enable clinicians across the US to use EchoSolv HF as a powerful decision support software to improve the early and accurate detection of heart failure - a condition that remains significantly under-diagnosed and under-treated.