• Bringing forward validation of ischaemia detection to expand clinical utility and commercial opportunity
• Pivotal trial recruitment surpasses key milestones, with clear path to full enrolment and FDA submission
• Regional Benefit Study progressing to demonstrate benefits of emuâ„¢ Brain Scanner in underserved areas

EMVision is actively preparing to add an acute ischaemia detection feature to its Pivotal (Validation) Trial for the emuâ„¢ brain scanner, following significant progress in the parallel Continuous Innovation study. Bringing forward the validation of ischaemia detection capabilities will streamline the regulatory pathway while maximising the clinical utility and commercial opportunity from the first FDA release. The Pivotal (Validation) Trial recruitment has surpassed key enrolment milestones (>125 total patients) and continues to build, with a path to full enrolment from late CY2026 / early CY2027 and sequential cohort readouts shortly thereafter. The addition of ischaemia detection is expected to substantially strengthen the device's clinical and commercial value proposition, as it extends the clinically actionable use case to the dominant majority (~80%) of stroke presentations. The emuâ„¢ Regional Benefit Study is also progressing to plan, with the goal of demonstrating the real-world benefits of the emuâ„¢ Brain Scanner in underserved regional areas. EMVision is well-funded to execute on its commercialisation milestones.

With the addition of ischaemia detection to the Pivotal Trial, EMVision is expanding the clinical utility and commercial opportunity of its emuâ„¢ Brain Scanner. The company is on a clear path to full trial enrolment, FDA submission, and commercialisation of the device.