Impedimed Limited · ASX:IPD
Impedimed — Citi 2012 Global Health Care Conference
20 slides from Impedimed's conference presentation, Feb 28, 2012
Slide 1: ImpediMed Company Presentation (ASX announcement)
ASX : IPD For personal use only 28 February 2012 ImpediMed Company Presentation Brisbane, Australia. – ImpediMed Limited (ASX: IPD) refers shareholders to the attached Company presentation being given today at the Citi, 2012 Global Health Care Conference in New York. For more information: Greg Brown
Slide 2: ImpediMed Limited Company Presentation February 2012
For personal use only ImpediMed Limited Company Presentation February 2012 1
Slide 3: Disclaimer
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, beliefs and assumptions and are subject to a number of risks and uncertainties. The forward-loo
Slide 4: Capital Structure and 12 Month Share Price Performance
Capital Structure Company listed on the ASX For personal use only Capital Structure – ASX: IPD 12 Month Share Price Performance Share Price4 A$ 0.53 Share pricing in AUD Listed shares on issue (million)1 156.3 $0.85 1600 Thousands $0.80 1400 Unlisted shares (million)2 0.2 $0.75 1200 $0.70 1000 Liste
Slide 5: Executive Summary
Executive Summary For personal use only Medical Device Company • Point of care testing device – razor/razor blade business model • Intellectual Property around technology platform and applications • First to market - targeting underserved areas in medicine Targeting Fluid Status Applications • Lymph
Slide 6: Lymphedema - Current Diagnosis is often too late
Lymphedema - Current Diagnosis is often too late For personal use only Reactive model of care today “Lymphedema is a chronic debilitating disease that is frequently misdiagnosed, treated too late, or not treated at all” - J Nucl Med 2003; 44:43–57 Often diagnosed when patient has visible sympt
Slide 7: Lymphedema Incidence Rates
Lymphedema Incidence Rates For personal use only See reference information at end of presentation Armer J and Stewart B: Post Breast Cancer Lymphedema. Incidence increases from 12 to 30 to 60 months. Lymphology 43 (2010) 118-127 Conclusion: LE incidence at 5 years: Ranged from 43%-94% depending on m
Slide 8: Bioimpedance Spectroscopy (BIS)
Bioimpedance Spectroscopy (BIS) For personal use only BIS technology directly measures the extracellular fluid At low frequency At high frequency Cell membrane Intercellular fluid Extracellular fluid ImpediMed’s BIS Technique 7 The device is not intended to diagnose or predict lymphedema of the extr
Slide 9: ImpediMed's L-Dex U400
ImpediMed’s L-Dex® U400 For personal use only Direct measure for extracellular fluid (ECF) differences of the limbs to aid in clinical assessment of unilateral lymphedema Pathophysiology of lymphedema shows ECF levels are relevant mainly for early changes. In chronic state ECF levels can decreas
Slide 10: Current Detection Methods - Synergistic for Different Stages of Lymphedema
Current Detection Methods - Synergistic for Different Stages of Lymphedema For personal use only Direct or indirect FDA clearance for Detection Method measurement, volume or Reproducibility/Accuracy lymphedema assessment ECW Tape measure Non-standardized, Volumetric calculation of limb by measuring
Slide 11: Regulatory Status
Regulatory Status For personal use only First FDA cleared device - Indications for use/intended use: A bioelectrical impedance analyzer/monitor for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extra cellular fluid vol
Slide 12: Targeting Multiple Fluid Status Markets
Targeting Multiple Fluid Status Markets For personal use only Lymphedema market - Arms Today & Near Term Lymphedema market - Legs Arms - female breast cancer Legs - pelvic cancer TGA, FDA, and CE cleared (Uni only) TGA, FDA, and CE cleared (Uni only) Estimate - US$150m+ annually 80% of m
Slide 13: Business Model - Reimbursement Critical to Drive Model
Business Model – Reimbursement Critical to Drive Model For personal use only Illustrative Device Economics Assumptions (based on primary target surgeon) Per Reading (USD) Target list price per reading up to US$85 Reimbursement¹ Up to $400 Clinician enrols 8 new patients per month Consumables¹ Up
Slide 14: Reimbursement Status
Reimbursement Status For personal use only 1. L-Dex reading coverage beginning in the market Coverage occurring sporadically– EOB’s showing reimbursement of CPT 0239T Examples of major private payers covering at local levels - only seen in certain states at present Payment is around an average
Slide 15: Clinical Studies - Payer Categories for Assessment
Clinical Studies – Payer Categories for Assessment For personal use only Early Dx/Treatment Reactive Care Clinical Assessment Improved Outcomes Poor outcomes Aid for Doctors - BIS • Key studies • Referred/Dx at later stage • Technical Performance • Campisi 2002 (RCT) (200ml difference) • Van Loan 19
Slide 16: Prospective Care / Early Treatment - Data supporting outcomes
Prospective Care / Early Treatment – Data supporting outcomes For personal use only 1 year 2 years 5 years 10 years Stout 2008 LaComba 2010 Boccado 2009 Campisi 2002 Johansson 2010 • Prospective 5 year • RCT comparing • 2year follow up– 55pts • 5 year follow up– 50pts • 10 year treatment F/U observa
Slide 17: Support Building for Prospective care
Support Building for Prospective care For personal use only NAPBC clinical Standard 2.15 “Support and Rehabilitation” Part of the comprehensive breast cancer care program. This standard strongly recommends lymphedema management and risk reduction practices for the treatment of all breast cancer
Slide 18: ImpediMed's Technology Stands to Benefit All Stakeholders
ImpediMed’s Technology Stands to Benefit All Stakeholders For personal use only Patients – common fear given incidence. New Prospective care model ensures education and risk reduction strategies for all patients, with prompt treatment at the earliest signs Providers - now have a medical device t
Slide 19: Next generation technology - UB500
Next generation technology - UB500 Uni- & Bi-Lateral arms and legs For personal use only 18
Slide 20: Summary Slide – final requirement is coverage
Summary Slide – final requirement is coverage For personal use only First to Market Addressing large underserved medical needs – improving outcomes & Economics Intellectual Property Patents, applications & trademarks - platform / lymphedema / edema Regulatory leadership First FDA cleared devic