• UCLA Health scheduled for site activation in two weeks with emu™ brain scanner now shipped
• Pivotal Trial Steering Committee assembled, comprised of international Key Opinion Leaders in stroke
• EMVision remains on track with study operations required for De Novo submission, with the Pivotal Trial recruitment target expected to be achieved during CY H1 2026

EMVision Medical Devices Limited (ASX:EMV) is pleased to provide an update on the Pivotal (Validation) Trial and Continuous Innovation Study for the emu™ brain scanner device. The impending activation at UCLA Health completes site initiations for the Pivotal Trial. UCLA Health is a leading U.S. academic health system and stroke centre, providing world-class patient care and advancing medical research and education. The UCLA site is led by Principal Investigator Dr May Nour, a dually trained vascular and interventional neurologist, as well as Medical Director of California's first Mobile Stroke Unit (MSU). UCLA Health site activation is scheduled in two weeks, with first patient enrolment anticipated shortly thereafter. All five other sites are actively recruiting and ramping up towards reaching the recruitment objective for the Pivotal Trial during first half CY 2026. A Trial Steering Committee has been assembled, with the first successful meeting held. The committee will continue to meet throughout the trial to provide independent, advisory oversight and strategic guidance to ensure the Pivotal Trial progresses well in line with its objectives and generates credible, decision-grade evidence for publication, regulatory approval and product adoption. The Continuous Innovation Study is progressing well at Princess Alexandra Hospital, Brisbane and John Hunter Hospital in Newcastle, with Box Hill Hospital added as the third study site. The Continuous Innovation Study aims to support the advancement of additional features and potential future indications for the emu™ device, such as point-of-care traumatic brain injury assessment.

EMVision remains on track with study operations required for De Novo submission, with the Pivotal Trial recruitment target expected to be achieved during CY H1 2026.