EMV Price sensitive 30 Jul 2025, 8:17 AM

Quarterly Activities/Appendix 4C Cash Flow Report

Emvision Medical Devices Ltd

EMVision Provides Quarterly Update on Key Progress

Key points

  • Pivotal trial for FDA clearance of emu™ bedside brain scanner progressing well
  • Continuous Innovation Study initiated to advance additional device features
  • First Responder portable brain scanner successfully tested in aeromedical and road ambulance environments
  • Awarded $5 million non-dilutive grant to accelerate First Responder commercialization

Full summary

EMVision Medical Devices Ltd (ASX:EMV) has provided a quarterly update on its key activities and progress. The company's primary focus is on the development and commercialization of portable, cost-effective, and non-invasive brain scanners, including the emu™ bedside device and the First Responder pre-hospital device. During the quarter, EMVision commenced the pivotal (validation) trial to support FDA De Novo clearance of the emu™ bedside brain scanner. The trial is being conducted across four sites in the US and two in Australia, all of which are high-volume comprehensive stroke centers. The company also initiated a Continuous Innovation Study to advance additional features for the emu™ device, such as point-of-care traumatic brain injury assessment.For the First Responder device, EMVision successfully completed aeromedical environment testing, demonstrating the device's ability to withstand the physical stress and operational constraints of aeromedical retrieval. The company has also obtained ethics approvals to conduct studies with the Royal Flying Doctor Service and the Melbourne Mobile Stroke Unit to further evaluate the First Responder's usability, reliability, and workflow.During the quarter, EMVision was awarded a $5 million non-dilutive Industry Growth Program grant from the Australian government to accelerate the global commercialization of the First Responder device. The company also expanded its leased premises to establish a pilot production line for the First Responder.EMVision has secured multiple podium presentations at high-profile events, including the World Stroke Congress and the Military Health System Research Symposium, to showcase its technology and products.The company ended the quarter with cash reserves of $10.5 million, which has since been bolstered by a $0.4 million non-dilutive milestone payment. EMVision continues to actively pursue additional non-dilutive funding opportunities to support its ongoing development and commercialization activities.

Guidance

EMVision has not provided any high-importance, price-sensitive forward-looking financial metrics or other company-specific metrics in the announcement.

Summary generated by a large language model. Please interpret with care.

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