• Seven world-class stroke hospitals actively recruiting under the Pivotal (Validation) Trial
• Extensive training verification has led to new software features undergoing in-house testing
• Activation of a second recruiting Memorial Hermann (Houston) network hospital in final stages

EMVision Medical Devices Ltd (ASX:EMV) has provided an update on the progress of the clinical programs for its first commercial product, the emuâ„¢ point-of-care Brain Scanner. The emuâ„¢ Pivotal (Validation) Trial, designed to support FDA De Novo clearance, has all six trial locations (4 US and 2 Australian) actively enrolling patients. The company has taken a deliberate and disciplined approach to preparing the trial, with a focus on site readiness, training verification, and data quality. Operational learnings from the training verification phase have been incorporated into the trial's execution, and a new software feature is being developed to provide users with real-time feedback on scan quality. Additional network sites are being activated at Mt Sinai (New York) and Memorial Hermann (Houston) to further enhance trial momentum. The emuâ„¢ Continuous Innovation Study, running in parallel to the Pivotal Trial, is progressing well and providing additional training data for algorithm enhancement, feature development, and indication expansion. The company has also been awarded a $3 million grant to support a Regional Benefits Study, which will evaluate the real-world benefits of using the emuâ„¢ Brain Scanner integrated with a telehealth network in regional hospitals across South Australia.

The company has not provided any high-importance, price-sensitive forward-looking financial metrics or other company-specific metrics.

The company expects the pace of enrolling for the emuâ„¢ Pivotal (Validation) Trial to continue to increase as the trial progresses, with recruitment generally following an 'exponential' pattern rather than a linear one.