• Commencement of study with Mayo Clinic Platform to evaluate EchoSolv HF
• Study in collaboration with Mayo Validate, an independent platform for AI model evaluation
• Final step prior to formal FDA submission for EchoSolv HF in H2 CY25

Echo IQ, an AI and medical technology company, has announced the commencement of a clinical validation study for its heart failure decision support software, EchoSolv HF, in collaboration with the Mayo Clinic Platform. The study will be carried out in conjunction with Mayo Validate, a unique program that evaluates the accuracy, efficacy, and bias of AI-based decision software. The commencement of the validation study follows the successful completion of the FDA pre-submission process for EchoSolv HF and marks the final regulatory requirement prior to the company's formal FDA submission, which is expected in the second half of 2025. The study aims to validate the EchoSolv HF model's ability to detect heart failure on an independent dataset, providing clinical evidence to support the company's FDA 510(k) application for the US market. The Mayo Clinic Platform, founded by the Mayo Clinic, is focused on the deployment of new technologies to achieve earlier and more accurate diagnoses and enhance personalized care. As part of the agreement, the Mayo Clinic Platform has the right to utilize EchoSolv HF within its network of 30 hospitals and co-brand the product. The completion of the pre-submission process and the commencement of the Validate study are critical for advancing the strategy to secure FDA clearance and market access for EchoSolv HF within the US.

Echo IQ remains confident of FDA clearance for EchoSolv HF during the second half of 2025.