• Excellent results from pre-validation 'EMView' clinical trial
• Validation (pivotal) trial for bedside scanner fast approaching
• Transformative ultra-light weight First Responder device fabricated

EMVision Medical Devices Ltd (ASX:EMV) has provided an update on its key activities during the December 2024 quarter. The company reported excellent results from the pre-validation 'EMView' clinical trial of its emuâ„¢ Bedside Scanner, with the device demonstrating high sensitivity and specificity in detecting hemorrhages and ischemic strokes. This has allowed EMVision to confidently proceed with preparations for the validation (pivotal) trial to support FDA De Novo clearance and product commercialization. The validation trial is expected to enroll up to 300 suspected stroke patients across 6 leading clinical sites in the US and Australia, with an anticipated enrollment duration of 6-12 months. EMVision has also fabricated a transformative ultra-light weight First Responder Proof-of-Concept brain scanner device, with a healthy human volunteer study underway and a pre-hospital feasibility study scheduled to commence this quarter. The company remains well-funded with proforma cash reserves of $15.78 million, including a $2.12 million R&D tax rebate received after the quarter end. EMVision's activities in FY25 will also be supported by $0.8 million in non-dilutive milestone payments from the Australian Stroke Alliance grant program.

EMVision expects the validation (pivotal) trial for the emuâ„¢ Bedside Scanner to commence this quarter, with market entry projected during CY26 assuming successful trial and regulatory outcomes.