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Investor Relations14 Oct 2025
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EMVision Medical Devices (EMV) investor relations material
EMVision Medical Devices Investor Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Investor Update summary9 Sep, 2025
Mission, Technology, and Product Overview
Focused on reducing global stroke and traumatic brain injury burden with two portable, non-ionizing brain scanning devices targeting unmet clinical needs in both pre-hospital and in-hospital environments.
Over $50 million invested in R&D, leveraging novel radio frequency sensing and imaging technology from the University of Queensland, with a robust IP portfolio of approximately 14 patent families and multiple design registrations.
Two main products: EMU™ device for hospitals and First Responder scanner for ambulances, both designed for rapid neurodiagnostics.
Clinical Validation and Regulatory Progress
300-patient pre-validation trial met primary endpoints, supporting progression to pivotal trial for FDA De Novo clearance, with high-profile sites like Mayo Clinic and Mount Sinai participating.
'EMView' study showed 92% sensitivity and 85% specificity for haemorrhage detection; 95% sensitivity and 80% specificity for ischaemia detection.
Pivotal (validation) trial underway at six sites (four US, two Australia), targeting completion in H1 CY2026, with additional innovation studies in Australia to enhance AI algorithms and expand indications.
Plan to leverage FDA clearance for expedited CE mark and TGA approval.
Market Opportunity and Commercialisation
Multi-billion dollar addressable market in stroke care, with additional opportunity in traumatic brain injury.
U.S. hospital market estimated at 3,000 high-priority sites, representing a $500 million capital equipment opportunity; First Responder scanner addresses 60,000 ambulances.
Revenue streams include device sales ($50,000–$200,000 per device; $175,000 for EMU™, $15,000–$100,000 for First Responder), consumables, and service contracts.
Initial commercialisation strategy targets the US 'Stroke Belt' region, prioritizing high-incidence areas and high-priority stroke centers and ambulances, with a phased go-to-market approach and direct sales model.
What is the expected NTAP reimbursement per scan?
When will you consider scaling sales via distributors?
What is the TBI market expansion strategy?
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Next EMVision Medical Devices earnings date
Q1 2026 TU27 Nov, 2025
Next EMVision Medical Devices earnings date
Q1 2026 TU27 Nov, 2025
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Frequently asked questions
EMVision Medical Devices Ltd is a medical technology company focused on the development of non-invasive imaging solutions for the diagnosis and monitoring of neurological disorders. The company’s primary innovation is its portable brain scanner, designed to use electromagnetic microwave imaging technology to rapidly detect and monitor conditions such as strokes. EMVision aims to provide healthcare professionals with accurate, bedside imaging tools that can improve the speed and effectiveness of patient care, particularly in emergency settings. EMVision Medical Devices Ltd is headquartered in Sydney, Australia, and its shares are listed on the ASX.
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