Slide 1: ASX Release – Shareholder Update Presentation
ASX: IPD 16 March 2010 For personal use only ASX RELEASE – Shareholder Update Presentation ImpediMed Limited wishes to post a company update presentation. Greg Brown ENDS For further information contact: Greg Brown ImpediMed CEO T: 61-7-3860-3700 Mobile/Cell: +61408281127 L-Dex® is a trademark of Im
Slide 2: ImpediMed Limited March 2010
For personal use only ImpediMed Limited March 2010 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 and beliefs and are subject to a number of factors and uncertainties that could cause actual res
Slide 4: Targeting Multiple Fluid Status Markets
Targeting Multiple Fluid Status Markets For personal use only Lymphoedema market - Arms Today & Near Term Lymphoedema market - Legs Arms – mainly breast cancer Legs – pelvic cancer Highest awareness 80% of market, 70% unilateral Estimate - US$150m+ annually Estimate -US$400m+ annually Fl
Slide 5: Lymphoedema – Current Diagnosis is Often Too Late
Lymphoedema – Current Diagnosis is Often Too Late For personal use only Presently diagnosed when patients can already have irreversible changes Successful treatment and potential prevention can occur with early detection (compression sleeve) 4
Slide 6: L-Dex U400's Initial Target Market is Breast Cancer Survivors
L-DexTM U400’s Initial Target Market is Breast Cancer Survivors For personal use only Breast cancer incidence in the US Lymphoedema association with breast cancer survivors US breast cancer incidence: After mastectomy: 24 - 49% Currently c.250,000 cases/year After lumpectomy: 4 – 28% Forec
Slide 7: True Innovation - Current Detection Methods are Sub-Optimal
True Innovation - Current Detection Methods are Sub-Optimal For personal use only Direct or indirect FDA clearance for Detection Method measurement, volume or lymphoedema Reproducibility/Accuracy ECW assessment Tape measure Volumetric calculation of limb by measuring Non-standardised and No diameter
Slide 8: Key Milestones & Events
Key Milestones & Events For personal use only ImpediMed Events April 2008 October 2008 June 2009 November 2009 December 2009 March 2010 FDA application for L- FDA clearance for 45 L-Dex TM devices devices in CPT code filing with 70 L-DexTM devices in Category III CPT code DexTM U400 L-DexTMU400 L-De
Slide 9: Current Device Placements in the US – Limited by Reimbursement
Current Device Placements in the US – Limited by Reimbursement For personal use only There are currently 121 users of the L-DexTM device with 71 L-DexTM Agreements in place Targeted key opinion leaders, placements also reflective of current regional sales presence Effective reimbursement criti
Slide 10: Business Model – Reimbursement Critical to Drive Model
Business Model – Reimbursement Critical to Drive Model For personal use only Illustrative Device Economics Assumptions Per Test Per Annum Target list price per test USD 45 (USD) (USD) Clinician enrols 8 patients per month Reimbursement¹ $100 $115,200 Quarterly testing over the first three year
Slide 11: Roadmap for Effective US Reimbursement – Three Critical Components
Roadmap for Effective US Reimbursement – Three Critical Components For personal use only All three components are critical for effective reimbursement Coding Payment Coverage CPT codes Clinician fee schedule National & local I,III or Miscellaneous Medicare & private payers A product that c
Slide 12: Coding – Category III CPT Code
Coding – Category III CPT Code For personal use only Previous Position – Miscellaneous CPT Code Not technology specific – “miscellaneous lymphoedema study” Documentation required from clinician regarding procedure Not possible to have coverage statement specific to application Hence manual r
Slide 13: Payment & Coverage – Delivered Through US Healthcare Payers
Payment & Coverage – Delivered Through US Healthcare Payers For personal use only US Health insurers by covered lives (2007) United Uninsured Humana 6% 16% others 3% 4% Aetna 5% Wellpoint BCBS 12% 33% Cigna 3% Kaiser CMS 3% 15% Approximately 800 plus payers of US Healthcare, multiple delivery system
Slide 14: Coverage Strategy - Targeting Major Payers
Coverage Strategy - Targeting Major Payers (max. coverage quickly) For personal use only Greater than 30 million covered lives Greater than 18 million covered lives Greater than 14 million covered lives HCSC only - greater than 12 million covered lives Greater than 9 million covered lives Greater th
Slide 15: Estimated Health Economics of L-Dex Aids Coverage & Payment
Estimated Health Economics of L-Dex Aids Coverage & Payment TM For personal use only Govt. financed healthcare in US (CMS) is mandated by law to be budget neutral with new technology 2 yr estimate of economic burden of breast cancer related lymphoedema (BCRL) “Matched cohort analysis showed that
Slide 16: External Factors Supporting Coverage - Legislative Support
External Factors Supporting Coverage - Legislative Support For personal use only State by State Coverage for Third-Party Payers to Offer or 1999: Federal Provide Lymphoedema Treatment (Mastectomy only) Women‟s Health Rights Act - Mastectomy 1999 – 2009: State Numerous state laws have been pu
Slide 17: How IPD Builds Coverage on its Code to Drive Placements & Sales
How IPD Builds Coverage on its Code to Drive Placements & Sales For personal use only Placements estimated to increase as the business model develops through effective reimbursement Expand direct managed care resources – reimbursement is a critical requirement to drive sales Expand sales team an
Slide 18: Targeting Broader Lymphoedema Patient Registry
Targeting Boarder Lymphoedema Patient Registry For personal use only MEDCAC panel meeting – “clinical evidence for the diagnosis and treatment of secondary Medicare Evidence lymphoedema” (September 2009) Development and Coverage Advisory Key suggestions: need for a standardised metric & patient
Slide 19: Patient Awareness – Will Work With Avon / Susan Komen
Patient Awareness – Will Work With Avon / Susan Komen For personal use only “Upper extremity lymphoedema is one of the most dreaded sequelae of breast cancer (BC) treatment” J Clinical Oncology, Vol 27, 2009 “The psychosocial impact of lymphoedema has been described to be as distressing as the initi
Slide 20: New Products Targeted to Drive Market Expansion
New Products Targeted to Drive Market Expansion For personal use only Status Alpha site trials completed Beta site trials targeted for second half 2010 – US Gynaecologic Oncology Group Pricing List price will target US$35,000 US$30 per reading (purchased) US$45 to $49 for L-DexTM agreement
Slide 21: Estimated News Flow – Next Months
Estimated News Flow – Next 18 Months For personal use only News Flow Pipeline: 2H10 1H11 2H11 Unilateral Leg Filing Announcement of first coverage statement Expansion of sales team and managed care team Publish Category three code in AMA coding book Announcement of 20 million covered lives Registry
Slide 22: Summary
Summary For personal use only Large Markets Several hundred million dollar consumables market First Mover First technology for routine fluid status monitoring IP Protected Patent protected technology platform (BIS) Validation Over a decade of clinical peer reviewed science FDA Clearance Fi
Slide 23: Appendix
For personal use only Appendix 22
Slide 24: Capital Structure
Capital Structure For personal use only Capital Structure – ASX: IPD 12 Month Share Price Performance Share Price A$0.89 $0.90 300,000 Listed shares in issue (million) 108.75 $0.85 250,000 $0.80 Unlisted shares (million)1, 2 0.38 $0.75 200,000 Listed options (million) 12.50 Share price A$ $0.70 Volu