Emvision Medical Devices Ltd. · ASX:EMV
Emvision Medical Devices — Investor Presentation (September 2025)
40 slides from Emvision Medical Devices's investor presentation, Sep 17, 2025
Slide 1: EMVision Capital Raising Presentation September 2025
For personal use only EMVISION (ASX:EMV) CAPITAL RAISING PRESENTATION SEPTEMBER 2025
Slide 2: Important Notices and Disclaimer
IMPORTANT NOTICES AND DISCLAIMER DISCLAIMER For personal use only This Presentation has been prepared by EMVision Medical Devices Ltd (ACN 620 388 230) (the “Company”) in relation to an equity capital raising by the Company consisting of a placement of Company shares to certain sophisticated and ins
Slide 3: Important Notices and Disclaimer
IMPORTANT NOTICES AND DISCLAIMER NOT AN OFFER Nothing in this Presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell securities. It does not include all available information and should not be used in isolation as a basis to invest in the Company. Th
Slide 4: 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 > $50m invested in groundbreaking research and em
Slide 5: 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 6: 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 2021 2050 1 in 4 adults will suffer from a stroke in their Stroke Statistics ∆ (Actual) (Estimate) lifetime. Stroke incidence 12 million 21 million +80% Around two-thirds of survi
Slide 7: Two Stroke Types Require Different Care Pathways
TWO STROKE TYPES REQUIRE DIFFERENT CARE PATHWAYS Confirmation of stroke and stroke type required before reliable triage, transfer or treatment decisions can be made For personal use only Ischaemic Stroke Care Haemorrhagic Stroke Care Pathway Decisions Pathway Decisions Triage / Transfer Triage / Tra
Slide 8: In Stroke 'Time Is Brain'
IN STROKE ‘TIME IS BRAIN’ Modern stroke treatments are highly effective but time critical Haemorrhagic Stroke Ischaemic Stroke For personal use only • Early blood pressure reduction • In the HERMES analysis of 1,287 • Thrombolysis administered in the first patients across 5 randomized trials, associ
Slide 9: 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 10: Evidence Supports Pre-Hospital Stroke Care
EVIDENCE SUPPORTS PRE-HOSPITAL STROKE CARE Mobile stroke units (MSUs) have demonstrated significant reductions in post-stroke disability and mortality ➢ With onboard imaging and specialist personnel, MSUs deliver hospital-grade Mobile Stroke Unit Costs For personal use only stroke diagnostics and tr
Slide 11: 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 12: 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 13: 'EMView' Case Studies
‘EMVIEW’ CASE STUDIES Highlight exceptional sensing capabilities, including successful detection and classification of very small strokes For personal use only Case #3 Case #1 R L RRR LLL Ground Truth Base Advanced Right convexity subarachnoid haemorrhage Left M2 occlusion ischaemic lesion on follow
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: Revenue Model
REVENUE MODEL Capital equipment & consumables model, complemented by monthly subscription offering where preferred For personal use only Coupling media Disposable cap Capital Equipment US$150,000 - $200,000 (target price range) Capital Equipment US$50,000 - $100,000 (target price range) Disposable i
Slide 17: Market Access Roadmap
MARKET ACCESS ROADMAP We are here Pre-Validation Trial (‘EMView’) Pivotal Trial (Validation) Regulatory Submission + Market Entry For personal use only COMPLETED Q3 CY2024 TARGET COMPLETION H1 CY2026 2026+ ONWARDS Liverpool Hospital, Royal Melbourne Hospital, Princess 6 sites Location Alexandria Hos
Slide 18: emu Clinical Roadmap
emu CLINICAL ROADMAP Pivotal (Validation) Trial For personal use only 300 suspected stroke patients (primary analysis) Participants (including 150 intracranial haemorrhages) Comprehensive Stroke Centres Sites (4 US, 2 AU sites) Primary Detection of haemorrhage Endpoint (>80% sensitivity / 80% specif
Slide 19: Initial Commercialisation Strategy: US Stroke Belt
INITIAL COMMERCIALISATION STRATEGY Targeted 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 22% higher death rate from stroke than rest of US Acade
Slide 20: Initial Commercialisation Strategy: Sales and Reimbursement
INITIAL COMMERCIALISATION STRATEGY Disciplined and insight-driven approach, with phased execution roadmap For personal use only Sales Model Reimbursement Strategy ➢ Commence with dedicated, high-touch direct service to Temporary Permanent build strong strategic relationships with key opinion leaders
Slide 21: 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 22: Commercialisation Enablers
COMMERCIALISATION ENABLERS EMVision’s path to market built around six core pillars For personal use only 1. Compelling value proposition Building persuasive clinical data and value proposition for our devices 2. Leading collaborations With top tier institutions, clinicians and key opinion leaders in
Slide 23: 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 24: Capital Structure (Pre Capital Raising)
CAPITAL STRUCTURE (PRE CAPITAL RAISING) ASX Ticker: EMV Strong Capital Management Track Record For personal use only Share Price (12 September) $2.32 Historic Funding Sources Shares on issue 85,516,535 30 Total Options on issue 4,200,000 25 Market Capitalization $198.4m 20 A$ MILLION Enterprise Valu
Slide 25: Capital Raising Overview
CAPITAL RAISING OVERVIEW Details of the capital raising • EMVision has received firm commitments to raise $12 million through the issue of approximately 6.2 million fully paid ordinary shares in EMVision (“New Shares”) at the TRANSACTION STRUCTURE AND Offer Price (as defined below) under a non-under
Slide 26: Placement Overview
PLACEMENT OVERVIEW Funds to be deployed over FY26 and FY27 to advance the Company through major milestones, including supporting clinical programs, FDA submission and initial commercialisation activities for the emu device, and advancing the First Responder device through clinical trials, production
Slide 27: Capital Raising Timetable
CAPITAL RAISING TIMETABLE EVENT DATE For personal use only Record date for eligibility to participate in SPP 7:00pm on Tuesday, 16 September 2025 Trading halt lifted, Placement completion announced Wednesday, 17 September 2025 Settlement of New Shares issued under the Placement Tuesday, 23 September
Slide 28: Appendix
For personal use only APPENDIX 28
Slide 29: 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
Slide 30: Technology Overview
TECHNOLOGY OVERVIEW Mobile and rapid neurodiagnostic modality for pre-hospital and bedside evaluation For personal use only Antennas Dielectric contrast Array of antennas send Signals influenced by Algorithm Portfolio non-ionizing ultra-high dielectric properties of tissue Signals obtained in minute
Slide 31: Opportunities to Improve Stroke Care
OPPORTUNITIES TO IMPROVE STROKE CARE Point-of-care diagnostics support effective decision-making when traditional neuroimaging is not available For personal use only Where should we take Can I initiate stroke Who should be Is the angio suite ready? this patient? therapies in the field? prioritized?
Slide 32: Potential Benefits to Hospitals
POTENTIAL BENEFITS TO HOSPITALS Prospective cost savings from optimised workflows and resource utilization For personal use only Health Economic Assessment Estimated potential financial benefits of an emu to a public hospital in Australia: Reduction in Transportation Costs $120,000 More efficient CT
Slide 33: Second Indication in Traumatic Brain Injury
SECOND INDICATION IN TRAUMATIC BRAIN INJURY Significant unmet clinical need for TBI screening For personal use only ➢ Each year, over 50 million people sustain a suspected TBI, with the estimated Existing FDA cleared solutions for point- cost to the world economy upwards of $400 billion. of-care TBI
Slide 34: FY25 Highlights
FY25 HIGHLIGHTS A landmark year across product, clinical, regulatory and corporate development For personal use only Positive FDA engagement ‘EMView’ study emu Pivotal Trial First Responder on Pivotal Trial design & First Responder emu Pivotal Trial presented at European Mount Sinai, NY and Advanced
Slide 35: Key Risks
KEY RISKS EMVision is subject to a variety of risk factors. This section discusses some of the key risks associated with an investment in Shares in EMVision. Some of these are specific to its business activities, while others are of a more general nature. Individually, or in combination, these risk
Slide 36: Key Risks
KEY RISKS Sales, marketing and adoption success The Company intends to focus on developing and marketing the Company’s the emuTM and First Responder devices. By its nature, there is no guarantee that the Company’s technology development and marketing campaign will be successful. In the event that it
Slide 37: Key Risks
KEY RISKS Reliance on key personnel The successful operation of EMVision in part relies on EMVision’s ability to attract and retain experienced and high performing key management personnel, in particular those with relevant scientific expertise. The loss of any key members of management or other per
Slide 38: Key Risks
KEY RISKS Litigation risk In the ordinary course of its business, EMVision may be subject to the risk of litigation and other disputes with its clients, employees, consultants, lessors, regulators and other third parties. Proceedings may result in high legal costs, adverse monetary judgements and/or
Slide 39: International Offer Restrictions
INTERNATIONAL OFFER RESTRICTIONS This document does not constitute an offer of new ordinary shares (“New Shares”) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold, in any
Slide 40: International Offer Restrictions
INTERNATIONAL OFFER RESTRICTIONS United Kingdom Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 20
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