Emvision Medical Devices Ltd. · ASX:EMV
Emvision Medical Devices — Shareholder Meeting (November 2025)
22 slides from Emvision Medical Devices's shareholder meeting presentation, Nov 11, 2025
Slide 1: AGM Chair's Address & Managing Director Presentation
11/11/2025 EMVision Medical Devices Ltd ACN 620 388 230 Suite 4.01, 65 Epping Rd Sydney NSW 2113 02 8667 5337 contact@emvision.com.au AGM CHAIR’S ADDRESS & MANAGING DIRECTOR PRESENTATION EMVision Medical Devices Limited (ASX:EMV) (“EMVision” or the “Company”) is pleased to provide copies of the Chai
Slide 2: Chair's Address (continued)
Our second device, the First Responder, a lightweight, portable version of our technology designed for use in ambulances and aeromedical retrievals, also took major steps forward during the year. Following the successful completion of initial aeromedical testing with the Royal Flying Doctor Service
Slide 3: About EMVision Medical Devices
About EMVision Medical Devices EMVision Medical Devices Limited (ASX:EMV) is an innovative Australian medical device company developing a novel approach to looking inside the human body. Our product pipeline includes portable, non- invasive, affordable and safe neuroimaging devices. Our vision is to
Slide 4: CEO Presentation 2025 AGM
For personal use only EMVISION (ASX:EMV) CEO Presentation 2025 AGM
Slide 5: Disclaimer
DISCLAIMER This presentation has been prepared by EMVision Medical Devices Limited (“EMVision” or “the Company”). This presentation is not a financial product or investment advice or recommendation, offer or invitation by any person or to any person to sell or purchase securities in EMVision in any
Slide 6: Introduction to EMVision
INTRODUCTION TO EMVISION Our mission is to reduce the global burden of stroke and traumatic brain injury through the deployment of two world- first portable brain scanning devices targeting unmet clinical needs For personal use only Over 15 years and > $60m invested in groundbreaking research and em
Slide 7: Meet the Team
MEET THE TEAM Significant medical device development and global commercialisation expertise Executive Leadership Team For personal use only Scott Kirkland Prof. Stuart Crozier Dr Christian Wight CEO, Managing Director, Co-founder Chief Scientific Officer, Co-inventor Head of Regulatory, Quality & Cl
Slide 8: Recent Highlights
RECENT HIGHLIGHTS A landmark year across product, clinical, regulatory and corporate development For personal use only $5m IGP Government emu Pivotal Trial First Responder emu Pivotal Trial grant to accelerate Go-to-market UCLA Health activated Strategy released to Successful aeromedical Mayo Clinic
Slide 9: Growing International Engagement and Recognition
GROWING INTERNATIONAL ENGAGEMENT AND RECOGNITION EXHIBITIONS CONFERENCES AWARDS OTHER Conferences Presentations • Mayo Clinic 17th Annual Stroke and Cerebrovascular Disease Review (USA) For personal use only • Military Health System Research Symposium (USA) • Novel Treatments of Acute Brain Injury (
Slide 10: Why Are We Starting in Stroke?
WHY ARE WE STARTING IN STROKE? Stroke remains a leading cause of mortality and disability globally For personal use only 1 in 4 adults will suffer from a stroke in their lifetime. Modern stroke treatments are highly effective, but they are time-sensitive and require Around two-thirds of survivors su
Slide 11: Today Traditional Neuroimaging Is Required for Stroke Diagnosis
TODAY TRADITIONAL NEUROIMAGING IS REQUIRED FOR STROKE DIAGNOSIS Conventional CT imaging is highly important in stroke care but is not widely accessible at the point-of-care For personal use only Mobile Stroke Units (MSUs) are custom-built ambulances fitted with a mobile CT Conventional CT Mobile CT
Slide 12: EMVision in the Stroke Care Pathway
EMVISION IN THE STROKE CARE PATHWAY Our mission is to help minimize time to treatment or intervention by bringing decision making to the patient’s location For personal use only Stroke Onset / Pre-Hospital Hospital Arrival & Triage Monitoring & Recovery Infield stroke detection & Initial scan(s) in
Slide 13: Strong Clinical Data
STRONG CLINICAL DATA Positive ‘EMView’ results & FDA engagement provided confidence to proceed with Pivotal (Validation) Trial Participants • 307 (277 suspected stroke patients, 30 healthy patients). ‘Haemorrhage or not’ Haemorrhage Not Haemorrhage For personal use only Total Test Cases 13 55 • Live
Slide 14: Collaborations & Grant Support
COLLABORATIONS & GRANT SUPPORT Established history of securing valuable industry collaborations and grants Industry Collaborations Current Grants For personal use only Product Collaboration, Substantial Shareholder First Responder (pre-hospital) Strategic product collaboration and supply for bespoke
Slide 15: Market Opportunity
MARKET OPPORTUNITY Multi-billion dollar addressable market for emu and First Responder emu Addressable Market First Responder Addressable Market For personal use only HOSPITALS ROAD & AEROMEDICAL AMBULANCES US GER, FRA, UK AUS Dev. ASIA US GER, FRA, UK AUS Dev. ASIA 10,200 5,960 545 12,850 60,000 58
Slide 16: Market Access Roadmap
MARKET ACCESS ROADMAP We are here Product Development + Clinical Studies Pivotal (Validation) Trial Regulatory Submission + Market Entry For personal use only ✓ Advanced prototype design ✓ Trial design and FDA engagement ✓ Submission to FDA for De Novo clearance ✓ Benchtop performance testing ✓ Site
Slide 17: emu Pivotal (Validation) Trial
emu PIVOTAL (VALIDATION) TRIAL Current Status 2025 Q3 2025 Q3 2025 Nov Steering Data Safety For personal use only • All six primary investigational sites live and enrolling Committee Monitoring Board • Data quality verified Meeting #1 Meeting #1 • Agreed to expand study conduct to network sites • St
Slide 18: Initial Commercialisation Strategy
INITIAL COMMERCIALISATION STRATEGY Targeted direct launch into the US expanded ‘Stroke Belt’ Market Launch High Priority Stroke Belt Targets For personal use only Comprehensive Primary Stroke Critical Access Stroke Centers Centers Hospitals 70 400 330 Initial Reimbursement Strategy: New Technology A
Slide 19: Longer Term Growth Strategy
LONGER TERM GROWTH STRATEGY Initial US launch used as playbook for national scaling, geographic expansion and indication extension For personal use only US National Penetration International Expansion New Indications Controlled national rollout, prioritizing Establish initial European presence in Tr
Slide 20: Upcoming Milestones
UPCOMING MILESTONES Transitioning from R&D focus to preparation for market access and commercialisation For personal use only emu and First Responder Clinical Programs Ongoing Value Drivers H2 CY2025 1H CY2026 Podium Strategy Pivotal (Validation) Trial Conferences, journal publications, Progress upd
Slide 21: Capital Structure
CAPITAL STRUCTURE ASX Ticker: EMV Strong Capital Management Track Record For personal use only Share Price (7 November) $1.85 Historic Funding Sources Shares on issue 92.9m 40 Total Options on issue 9.6m 35 Market Capitalization $171.9m 30 A$ MILLION 25 20 Cash balance (30 September 2025) $18.4m 15
Slide 22: Clinical Feedback
CLINICAL FEEDBACK Professor Geoffrey Donnan AO For personal use only Stroke Neurologist “It cannot be underestimated how important this cutting-edge technology could become for future stroke Co-chair ASA, Past-President of World Stroke management.” Organization Professor Stephen Davis AO Stroke Neur
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