• Exceptional results from 'EMView' pre-validation trial
• Positive meeting with FDA on pivotal trial design
• Pilot commercial production line established
• First Responder proof-of-concept scanners developed

EMVision Medical Devices Ltd (ASX:EMV) has released its Appendix 4D Half-Yearly Report & Accounts for the period ended 31 December 2024. The company announced exceptional results from its 'EMView' pre-validation multi-centre trial, which deployed its world-first neurodiagnostic portable brain scanner device (emu™) for identifying stroke and stroke type (haemorrhage or ischemia). Diagnostic algorithms tested on unseen data demonstrated high performance, with haemorrhage or not ('blood or not') Sensitivity of 92% and Specificity of 85%, and ischemia or not ('clot or not') sensitivity of 85% and specificity of 78%. The company also had a positive meeting with the FDA, providing confidence in the pivotal (validation) clinical trial design to support emu™ FDA De Novo clearance. Shortly after the half-year end, Central IRB (Institutional Review Board) ethics approval was received for EMVision's pivotal (validation) multi-centre diagnostic performance trial of the emu™ brain scanner in the US, which was designated non-significant risk (NSR) by the IRB. EMVision also completed a pilot commercial production line with the capacity for the build, test and release of up to 3 emu™ brain scanners per week, and produced its first ultra-light weight First Responder proof-of-concept scanners designed for road and air ambulance deployment, which leverage the principles and mode of operation of the emu™ device.

EMVision's cash reserves of $13.6m as at 31 December 2024 were further bolstered with the receipt of a $2.1m R&D tax rebate in January 2025, positioning the company well to execute its clinical validation plan.

EMVision's key upcoming milestones include the commencement of the emu™ pivotal (validation) trial in March 2025, the start of the First Responder pre-hospital study also in March 2025, and the execution of the company's high-impact publication, presentation and exhibition podium strategy to enhance industry visibility and market positioning.