• Five of six Pivotal Trial sites now actively enrolling and scanning patients
• Approval received to commence Continuous Innovation Study at two leading hospitals
• Pivotal Trial designed to support FDA De Novo clearance for EMVision's first commercial product

EMVision Medical Devices Limited (ASX:EMV) has provided an update on the progress of its Pivotal (Validation) Trial and the commencement of its Continuous Innovation Study for its emu⢠bedside brain scanner. Five of the six Pivotal (Validation) Trial sites are now actively enrolling and scanning patients, with the final sixth site expected to be announced shortly. The Pivotal (Validation) Trial is designed to support FDA De Novo clearance for EMVision's first commercial product, the emu⢠point-of-care bedside brain scanner. This clearance would open global market access opportunities, allowing the emu⢠brain scanner to improve neurodiagnostic access through its ease of use, non-ionising radiation and portability. In parallel to the Pivotal (Validation) Trial, EMVision is implementing a cost-effective Continuous Innovation Study to support ongoing device innovation, algorithm enhancement and data to support indication expansion (traumatic brain injury). Ethics approval has been received to commence scanning patients with suspected stroke or traumatic brain injury at Princess Alexanda Hospital (Brisbane) and John Hunter Hospital (Newcastle), both high volume Comprehensive Stroke and Level 1 Trauma Centres.

The Pivotal (Validation) Trial for the emu⢠device has an estimated enrolment period of 6-12 months, followed by analysis and reporting of the clinical data. The emu⢠device is then anticipated to become the predicate device for EMVision's second commercial product, the First Responder device, allowing an expedited 510(k) FDA pathway for the pre-hospital market (i.e. ambulance and aeromedical services).