EMVision Medical Devices (EMV) Investor Update summary

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.