4dmedical Ltd. · ASX:4DX
4dmedical — Bell Potter Healthcare Conference 2023
44 slides from 4dmedical's conference presentation, Nov 14, 2023
Slide 1: Presentation to Bell Potter Healthcare Conference
ASX announcement ASX:4DX Presentation to Bell Potter Healthcare Conference 13 November 2023 Melbourne, Australia, 13 November 2023: Respiratory imaging technology company 4DMedical Limited (ASX:4DX, “4DMedical”, or the “Company”) is pleased to provide a copy of the presentation to be delivered by Dr
Slide 2: The future of lung health
The future of lung health 4DMedical Limited (ASX:4DX) Investor Presentation November 2023
Slide 3: Disclaimer
Disclaimer This presentation has been prepared by 4DMedical Limited (ACN 161 684 831) (Company or 4DMedical). This presentation contains summary information about the Company, its subsidiaries and the entities, businesses and assets they own and operate (Group) and their activities current as of 13
Slide 4: Overview
Overview aX 4DMedical
Slide 5: FY23 achievements
FY23 achievements 1H FY2023 Commercialisation Early-stage commercialisation in Australia June 2022 Expanded relationship with Australia’s I-MED Radiology Network Clinical validation Burn pit trial validates XV Technology® August 2022 Burn pit clinical trial conducted by US-based Vanderbilt Universit
Slide 6: FY23 achievements
FY23 achievements 2H FY2023 Commercialisation Signing of first US hospital SaaS contract April 2023 5-year contract signed with the University of Miami to provide XV LVAS® ventilation reports, its first US hospital SaaS contract Commercialisation Dr David Shulkin joins 4DMedical April 2023 Former U.
Slide 7: FY24 achievements to date
FY24 achievements to date 1H FY2024 Government 4DMedical wins $1.1m CTCM funding July 2023 funding Funding enables expansion of XV Scanner capability beyond ventilation into perfusion Leadership and Appointment of Geraldine McGinty to Board September expertise Appointment of Geraldine McGinty provid
Slide 8: FY24 target catalysts
FY24 target catalysts Commercialisation • VA funded trial • 2nd Authority to Operate awarded enabling National Authority to Operate • Extend Department of Defense engagement • Execution of commercial agreement with US based academic medical center • Expansion in ANZ Clinical • Commencement of trials
Slide 9: U.S. healthcare landscape
U.S. healthcare landscape U.S. healthcare insurance market covers approximately 90% of the population Health insurance services are provided by both Established pathway for reimbursement for the private and public sectors new technologies 1. Private sector health insurance • Regulatory clearance or
Slide 10: U.S. reimbursement process
U.S. reimbursement process What does 4DMedical need to secure reimbursement with public & private payers in US? Addressing 3 key components of Requiring considerable stakeholder Answering the question: reimbursement engagement across multiple bodies ‘What is the UNMET NEED?’ • American Medical Assoc
Slide 11: Investment opportunity
Investment opportunity Global demand • The demand for sophisticated respiratory diagnostics solutions is growing • Diagnostic technology largely unchanged for ~50 years • Lung diagnostics market ripe for disruption Global • Commercialisation driven by clinical utilisation demonstrating medical neces
Slide 12: Background
Background if mY 2X 4DMedical .-: |
Slide 13: World first technology
World first technology Global medical technology company 4DMedical Limited (ASX:4DX) We have invented technology to accurately and quickly understand the lung function of patients with respiratory diseases. Flagship patented XV Technology® Enabling physicians to understand regional airflow in the lu
Slide 14: CEO quote on 4DMedical technology
“4DMedical has all the advantages and none of the disadvantages of existing lung diagnostic technology. Our XV Technology® and Lung Ventilation Analysis Software (XV LVAS®) is the latest evolution. The opportunities are significant.” Professor Andreas Fouras Founder, Inventor Managing Director & Chi
Slide 15: Corporate overview
Corporate overview Share price performance | 1 November 2022 - 31 October 2023 Trading information as at 31 October 2023 52 week high A$1.16 1.40 8,000,000 52 week low A$0.30 1.20 7,000,000 Number of shares 346.5M 6,000,000 Share Price (A$ Daily VWAP) 1.00 Market capitalisation (31 Oct 2023) A$159.4
Slide 16: Global market disruption opportunity
Global market disruption opportunity Four existing lung diagnostic technologies: CT, X-ray, Nuclear Medicine, Pulmonary Function Tests Expenditure (USD $B) 17.5 X-ray Technology Computed 15.0 Tomography (CT) 12.5 Procedures 253m 10.0 Expenditure USD $14.5b Procedures 44.5m Expenditure USD $11.9b 7.5
Slide 17: Global market revenue opportunity
Global market revenue opportunity Market opportunity by country1 Country Spend (USD) Procedures U.S.A 13,716M 73.5M Others 4,964M 59.8M Germany 2,678M 20.3M Japan 1,905M 22.8M China 1,851M 101.6M UK 1,351M 8.9M France 1,191M 10.2M Spain 780M 8.4M Italy 681M 8.5M Canada 606M 8.0M South Korea 450M 6.8
Slide 18: Investment opportunity – well funded for growth
Investment opportunity – well funded for growth Significant commercialisation momentum • First US hospital contract signed with University of Miami for provision of XV Technology®, establishing a framework in the US • Successful completion of first commercial scan with U.S. Veteran Affairs (VA), at
Slide 19: Leadership
Leadership re ; 4 =~. wn i a 2X 4DMedical .-:
Slide 20: Board of Directors Key advisors
Board of Directors Key advisors Significant medical and commercial sector experience Medical experts Dr SAM HUPERT MBBS Advisory Board Member Co-founder and Chief Executive Officer of Pro Medicus Ltd (ASX:PME) which develops and markets health imaging software primarily for radiologists in the U.S.,
Slide 21: Executive team
Executive team Accelerating 4DMedical’s patient outcomes and commercialisaton Dr ANDREAS FOURAS PhD RACHAEL TENKATEN Dr AIDAN JAMISON PhD NICHOLE MURRAY Managing Director and CEO Chief of Staff Senior Vice President Engineering Vice President Regulatory Affairs & Quality Assurance Award-winning aero
Slide 22: Software
Software Digital rendering of 4DMedical’s XV Technology®
Slide 23: Software offering & applications
Software offering & applications 4DMedical Current product XV LVAS® CT LVAS™ CT:VQ Currently in software offering release (ventilation) (ventilation) (ventilation / perfusion) development Image acquisition modality X-ray XV Scanner CT Existing hospital & 4DMedical hardware utilising Existing hospita
Slide 24: Software as a Service (SaaS) revenue model
Software as a Service (SaaS) revenue model 4DMedical XV Technology® XV LVAS®/CT LVAS™ Technology Commercialisation Lung scanner software already offered as SaaS to healthcare Underway; high gross margins and hardware providers • Robust patented IP portfolio • Rapid SaaS deployment • Demonstrable pro
Slide 25: XV Technology® advantages
XV Technology® advantages New medical insights Improved safety Superior results Functional insight of Comparable radiation High-detail resolution spirometry at a regional level dose to X-ray of a CT scan Patient outcomes Time efficient Low cost Improved clinical Faster, more efficient Competitive pr
Slide 26: 4DMedical’s XV lung ventilation analysis software results
4DMedical’s XV lung ventilation analysis software results XV technology allows for the detection of high and low areas of ventilation with pinpoint accuracy, with ventilation being calculated for all parts of the lung, in all phases of the breath. 25
Slide 27: Hardware
Hardware Digital rendering of 4DMedical’s XV Scanner
Slide 28: 4D lung scanner hardware
4D lung scanner hardware Invented to support 4DMedical’s XV Technology® • Increasing throughput, reducing costs for healthcare providers • Facilitating access to XV Technology® for more patients, including children and the very unwell unable to be scanned using conventional imaging equipment • Accel
Slide 29: 4D lung scanner unveiling at RSNA & ATS, deployment at SAHMRI and UNSW
4D lung scanner unveiling at RSNA & ATS, deployment at SAHMRI and UNSW • XV Scanner on display at two major global industry conferences: • Radiological Society of North America (RSNA 2022) • The American Thoracic Society (ATS 2023) • Recipient of ‘Best in Show’ exhibitor award at ATS 2023 • Commerci
Slide 30: Product pipeline
Product pipeline Extending accessibility
Slide 31: CT:VQ development
CT:VQ development Extends accessibility of perfusion and ventilation, reduces costs and improves productivity, and enhances patient experience Why CT:VQ? Status and next steps 1. Clinical care and coordination • Announced at ATS 2023 (May 2023) CT:VQ progressing to development • Workflow transition
Slide 32: XV Scanner and extension to measurement of perfusion
XV Scanner and extension to measurement of perfusion Broadening the capability of 4DMedical’s XV Scanner • Successful application for CTCM funding – received $1.1m • Purpose of the funding is to broaden capability of XV Scanner to include measurement of blood flow (perfusion, Q) • Will strengthen pr
Slide 33: Commercialisation progress
Commercialisation progress
Slide 34: Commercialisation strategy
Commercialisation strategy Clinical trials Commercial pilots Long term agreements Validating efficacy and utility Generating clinical use case Sustainable revenue generation Research partners delivering the body Physicians gaining familiarity with Long term agreements with hospital of scientific evi
Slide 35: Commercialisation update – near term
Commercialisation update – near term Immediate focus on targeting VA and ANZ rollout, which are not dependent on reimbursement Recent wins Target for FY2024 • First commercial scan conducted at Harry S. Truman • Paid commercial pilot Memorial VA • Attaining second Authority to Operate (ATO), and • F
Slide 36: Commercialisation update – medium term
Commercialisation update – medium term Medium term focus is on achieving reimbursement in the U.S. for XV Technology® product suite Recent wins Target for FY2024 - 2025 • University of Miami Hospital commercial • Commencement of trials for CT:VQ agreement • FDA submissions for XV Scanner and CT:VQ L
Slide 37: XV Scanner commercialisation update
XV Scanner commercialisation update Extension of capability to include measurement of perfusion Recent wins Target for FY2024 • Delivered on project milestones and ensure • Seeking regulatory approval in US receipt of funding of $9.5m in November 2022 • Extending capability to measurement of perfusi
Slide 38: Commercialisation strategy – clinical trial validation
Commercialisation strategy – clinical trial validation BLVR Asthma Paediatric CF Lung Transplant ILD-WLL University of Miami Cleveland Clinic John Hopkins Alfred Hospital, Melbourne Prince Charles Hospital XV LVAS® XV LVAS® XV LVAS® XV LVAS® XV LVAS® Imaging in progress & PH COPD BLVR COPD CF patien
Slide 39: Demonstrating clinical application
Demonstrating clinical application
Slide 40: Demonstrating clinical application: reliability & repeatability
Demonstrating clinical application: reliability & repeatability Indication: healthy male with no signs of disease (age 30s) Baseline Follow-up scan (3 months) CT Scan XV imagery of lung ventilation CT Scan XV imagery of lung ventilation TV VH VDP TV VH VDP 0.77 44.5 13.8 0.77 44.5 13.8 Summary: Clin
Slide 41: Demonstrating clinical application: Silicosis
Demonstrating clinical application: Silicosis Indication: Novel treatment for a Severe Progressive Silicosis related Occupational Lung Disease (Male aged 36) Baseline Follow-up scan (3 months post-treatment) CT Scan XV imagery of lung ventilation CT Scan XV imagery of lung ventilation TV VH VDP TV V
Slide 42: Demonstrating clinical application: COPD
Demonstrating clinical application: COPD Indication: Prior biologics therapeutic for re-current exacerbation of moderate obstructive lung disease (Male, age 60) Baseline Follow-up scan (5 months post-treatment) Structural CT Scan XV imagery of lung ventilation Structural CT Scan XV imagery of lung v
Slide 43: Demonstrating clinical application: Long Covid-19
Demonstrating clinical application: Long Covid-19 Indications: Long Covid symptoms (Female; age 52) Baseline Follow-up scan (3 months post-treatment) Structural CT Scan XV imagery of lung ventilation Structural CT Scan XV imagery of lung ventilation TV VH VDP TV VH VDP 0.50 54.5 17.3 0.59 47.3 13.8
Slide 44: 4DMedical Limited (ASX:4DX) Investor Presentation November 2023
4DMedical Limited (ASX:4DX) Investor Presentation November 2023 Copyright ©4DMedical Limited 2023 Level 7, Melbourne Connect 700 Swanston Street Melbourne, Victoria 3053 Australia www.4dmedical.com ABN 31 161 684 831