Slide 1: ImpediMed October 2014
For personal use only ASX:IPD October 2014
Slide 2: Disclaimer
For personal use only This presentation has been produced by ImpediMed Limited (“ImpediMed”) only and may contain forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to dif
Slide 3: Game changing technology platform
For personal use only Game changing technology platform • Bioimpedance spectroscopy (BIS) accurately measures tissue composition and fluid status First product, L-Dex®, addresses a growing medical need • Lymphoedema affects approximately 20% - 30% of cancer survivors • A precise and cost effective s
Slide 4: Reimbursement, key appointments and post approval study
For personal use only Reimbursement • CPT Category I Code effective January 2015 • CPT descriptor for all cancer related lymphoedema expected to significantly expand the market opportunity – September 2014 • A leap forward in commercial strategy, allowing IPD to pursue maximum market for L-Dex at le
Slide 5: Fluid imbalance can have significant clinical implications
For personal use only • Fluid imbalance can have significant clinical implications • Fluid levels are incredibly predictive (actionable information) • Excess fluid can lead to chronic swelling, lymphoedema, left ventricular complications, etc. • Excess fluid is also indicative of heart failure stage
Slide 6: Current measurement tools are rudimentary and unreliable
For personal use only • Current measurements tools are rudimentary and unreliable, or prohibitively expensive, Imaging* complicated and invasive • High-tech tools include CT scan, MRI, X-Ray absorptiometry, Perometry isotope dilution (lymphoscintigraphy) and Tape Measure* perometry • Low-tech tools
Slide 7: Bioimpedance spectroscopy uses 256 frequencies
For personal use only • Measurements using Low Frequency High Frequency bioimpedance at a single frequency can be used to estimate body composition (limited capabilities) • However, multiple frequencies are required to obtain complete information of tissue composition and fluid burden • ImpediMed’s
Slide 8: Informative, simple, fast, non-invasive, safe, accurate
For personal use only • Informative – 256 frequency spectra provides detailed measurements of muscle, fluid, and fat • Simple to Use – easy placement of electrodes • Fast – 5-10 mins to measure • Non-invasive – no dyes or radiation • Safe – no safety concerns reported after thousands of measurements
Slide 9: US addressable market $350+ million per year
For personal use only • US addressable market $350+ million per year (assumes $30 per reading) • Lymphoedema affects ~1 in 3 cancer survivors • 900,000+ relevant new cancer cases per year • Lymphoedema is a progressive swelling that can occur following cancer treatment due to lymph nodes being remov
Slide 10: Clinical practice moving towards early detection
For personal use only • Clinical practice is moving towards early detection and early intervention • Current techniques used to assess lymphoedema cannot detect it before it is visibly apparent • L-Dex is able to detect minute changes in extracellular fluid (i.e. 35 mls versus other technologies 200
Slide 11: Patient testing protocols and addressable market
For personal use only Annual US Relevant Cancer Incidences1 939,000 Patient Testing Protocols (assuming $30 per reading) Per Patient Year 1 Year 2 Year 3 Year 4 Year 5 Total Readings 5 1-4 1-4 1-2 0-2 8 - 17 Revenue $150 $30 - $120 $30 - $120 $30 - $60 $0 - $60 $240 - $510 Addressable Per Annum US L
Slide 12: Focusing on top US oncology practices and institutions
For personal use only Focusing on top US oncology practices and institutions (deliberate and disciplined approach) • Increased opportunity for US market based on securing descriptor for all cancers • Initial Objectives – lay foundation for long-term sustainable growth and expansion of technology • P
Slide 13: Concentrate initial sales on select large oncology sites
For personal use only • Concentrate initial sales and support efforts on optimising uptake and processes at select large leading oncology sites • Targeting six major oncology groups over coming 12 months • Establish best practice at each of the six sites for: • Practice integration and patient flow
Slide 14: Clinical, marketing and reimbursement expansion
For personal use only Clinical • Standardising testing protocol • Practice integration • Patient education • Expand practice guidelines to National Comprehensive Cancer Network (NCCN) Marketing • Expand to all cancer related lymphoedema • Expand patient advocacy groups – key markets • Direct to pati
Slide 15: Position statements and published guidelines
For personal use only Key position statements on early detection of lymphoedema - recommendations for BIS • Australasian Lymphology Association (ALA), Aus • National Lymphedema Network (NLN), US • National Accreditation Program for Breast Centers (NAPBC), US Formally published guidelines • Kaiser Pe
Slide 16: Third party studies in US and Europe
For personal use only United States • 2 randomised controlled trials (n ~100 each site) being conducted at large teaching hospitals • Both investigating whether early intervention, identified with BIS, halts the progression of lymphoedema • Comparison between L-Dex and tape measure or water displace
Slide 17: International sponsored study
For personal use only • To help drive adoption ImpediMed is also sponsoring an international study • Study commenced in June 2014 with Vanderbilt already recruiting patients. All trial sites expected to be live by year end • Large (n=1,100), multi-centre, randomised controlled study to prove that us
Slide 18: BIS platform for fluid levels and tissue composition
For personal use only BIS is a platform technology for precise measurement of: • Fluid Levels – e.g. fluid burden; fluid change; hydration; oedema • Tissue Composition – e.g. fat mass; lean body mass Fluid Levels and Tissue Composition are incredible predictors of health • Fluid Levels- e.g. lymphoe
Slide 19: Upcoming milestones and growth drivers
For personal use only • CMS announces new Medicare payment rates November 2014 • CPT codes and new Medicare payment rates implemented January 2015 • Accelerating revenue in the US on the back of the CPT I code • Medicare reimbursement expected January 2015 • Building private payer adoption • Increas
Slide 20: Thank You
For personal use only Thank You
Slide 21: Appendix
For personal use only Appendix
Slide 22: Corporate Overview
Corporate Overview • ASX listed (October 2007) Share Price Performance – CY2014 For personal use only • Operations in US (San Diego) and Aus (Brisbane) • Transformed Board & Management in 2013 • 37 FTE staff • Market capitalisation ~$107M (~239M shares on Issue) • Cash on hand $9.5M (30 September 20
Slide 23: Financials
Financials FY2014 FY2013 % Change For personal use only $000 $000 Lymphedema Revenue 1,594 1,188 34% ↑ Body Composition Revenue 891 728 22% ↑ Test & Measurement Revenue 1,036 817 27% ↑ Total Group Revenue 3,521 2,733 29% ↑ Operating Expenses 9,967 10,751 7% ↓ Operating Loss 7,935 8,464 6% ↓ Lymphede
Slide 24: Management Team
Management Team Has Deep and Broad Commercialisation Experience Rick Carreon •Joined July 2012 President and Chief •30+ years experience For personal use only Executive Officer •Extensive experience in the medical device field and growth companies •Previously Vice President at Medtronic (10 years) F
Slide 25: Board of Directors
Board of Directors Cherrell Hirst AO •On Board since 2005 FTSE, MBBS, BEdSt, D.Univ •Appointed Non-Executive Chairman in Nov 2011 For personal use only (Hon), FAICD •Leading medical practitioner in breast cancer screening/diagnosis Non-Executive Chairman •Currently a Director of Tissue Therapies Ltd