Impedimed Limited · ASX:IPD
Impedimed — Non-Deal Roadshow (December 2007)
22 slides from Impedimed's roadshow presentation, Dec 18, 2007
Slide 1: ImpediMed roadshow presentation cover note
ImpediMed Limited ABN 65 089 705 144 www.impedimed.com ASX : IPD For personal use only Tuesday 18th December 2007 ImpediMed Limited wishes to advise that CEO Greg Brown is delivering the attached roadshow presentation to various institutional investors and broking houses during the remainder of this
Slide 2: Surviving cancer without compromising lifestyle
For personal use only ImpediMed Limited Surviving cancer without compromising lifestyle
Slide 3: ImpediMed overview
ImpediMed overview For personal use only Australian company – ASX Listed Listing raised $18 million Acquired San Diego based BIS company Xitron Technologies Professional investors - Versant ventures (Menlo Park California), Starfish ventures Internationally te at o a y e experienced pe e c
Slide 4: Lymphoedema – what is it?
Lymphoedema – what is it? For personal use only Lymphatic system Transports a spo s anda d filters e s waste as e p products oduc s of o the e ce cellss It is the primary component of the immune system Lymphoedema - Primary and secondary breakdown of the lymphatics where transport capacity fal
Slide 5: Current care and diagnosis
Current care and diagnosis For personal use only Current diagnosis and standard of care Lymphoedema y p is a chronic debilitating g disease that is frequently q y misdiagnosed, treated too late, or not treated at all J Nucl Med 03; 44:43–57 Patients often suffer in silence when their primary c
Slide 6: Lymphoedema prevalence
Lymphoedema prevalence For personal use only Approximately 10 million Americans, as an example, have lymphoedema secondary to breast and pelvic cancer therapy, recurrent infections, injuries, or vascular surgery J Nucl Med 2003; 44:43–57 32 percent off women aged d 45 years andd younger treated
Slide 7: Why ImpediMed is well positioned
For personal use only Why ImpediMed is well positioned Targeting prevention of lymphoedema progression
Slide 8: 1. Technology validation
1. Technology validation For personal use only BIS technology measures the extra-cellular fluid of limbs directly At low frequency At high frequency Cell membrane ICF ECF Over 10 years of peer reviewed publications since 1996 demonstrating early detection, clinical assessment and risk assessment
Slide 9: 2. Commercial and regulatory status
2. Commercial and regulatory g y status For personal use only XCA First FDA cleared medical device for the clinical li i l assessment for f uni-lateral il l lymphoedema of the arm Single low frequency – patented Uni-lateral arm onlyy – control limb Distribution building Longer term homec
Slide 10: 2. Commercial and regulatory status (continued)
2. Commercial and regulatory g y status ((continued)) For personal use only SFB 9 Clinical routine device FDA submission for the clinical assessment for uni- & bi-lateral lymphoedema of the arm and legs - targeting 510K specials to the SFB7 Prototype in late 2008 for trials Target T t comm
Slide 11: 3. Building clinical data supporting early detection
3. Building clinical data supporting pp g early y detection For personal use only Prospective NIH/NCI trial in breast cancer patients started 2000 and completed end of 2006 The 5 year study took measurements using a standard volumetric technique (Perometer) from baseline Lymphoedema where dete
Slide 12: 4. Targeting proposed new clinical paradigm: pre-emptive care
4. ImpediMed targeting proposed new clinical paradigm: p g p pre-emptive p care For personal use only $500 to $120 to $240/ year/ homecare patient in $1000 consumables Surgeon / Oncologist Device Surgeon Baselines patient Risk Assessment 2 x Misc code 2 x Misc code High Risk Patient - Homecare Cance
Slide 13: 5. Reimbursement – targeting miscellaneous codes
5. Reimbursement – targeting miscellaneous codes until category one code is available For personal use only Code Major Title Minor Titles Excludes 457 Noninfectious disorders of lymphatic channels 457.0 Postmastectomy Elephantiasis (due to mastectomy) lymphedema syndrome Obliteration of lymphatic ve
Slide 14: 6. Strategic partnerships
6. Strategic partnerships For personal use only Decongestive therapy schools (CTS) Norton’s ’ andd Vodder dd (global) ( l b l) Estimated 3000 to 5000 specialist therapists in the US Compression sleeve suppliers (global) Targeting distribution partners Physicians and aged care (US only)
Slide 15: 7. Estimated market potential
7. Estimated market potential – significant potential For personal use only Annual Total Device Summary - US lymphoedema Consumable Market Market Breast Cancer – Home devices & consumables $ 493 $ 142 Breast Cancer – Consumables provider market $ 71 P l i Cancers Pelvic C – Home H d devices i & cons
Slide 16: Other ImpediMed opportunities
For personal use only Other ImpediMed opportunities Hydration and other imaging applications
Slide 17: Hydration/body composition market targets
ImpediMed hydration/body composition market targets For personal use only Cachexia market Research markets Chemo New drug development Elderly Nutritional studies AIDS Dialysis Hydration Market $1.0 B device $0.1 B consumables Imaging markets Dialysis market DEXA suppliers Dry mass ma
Slide 18: Targeting diagnosis of metabolic disorder syndrome
Targeting g g diagnosis g of metabolic disorder syndrome y For personal use only Contracted research with a European university Visceral / subcutaneous abdominal fat differentiation BIS application – imaging modality to quantitate the difference in abdominal fatness Will be b a 1 minute i t
Slide 19: Senior Management
Senior Management For personal use only Greg Brown: CEO Digene – US/Europe :VP Global Strategic Marketing 6 Yrs Roche – Switzerland/USA (NY) : Global Marketing Director 4 Yrs Baxter – Australia/Germany/UK : Sales & Marketing Director 9 Yrs Phil Auckland: CFO / COO PanBio Ltd – CFO : Listed, Acquisit
Slide 20: Board of Directors
Board of Directors For personal use only Mel Bridges BSc FAICD – Non Executive Chairman Chairman of Alchemia (ASX:ACL) CEO and founder of Panbio Limited (ASX:PBO) until 2003; Founder and MD of Pacific Dx, sold to Baxter Director of Delvtech . Previously Chairman of Peptech (ASX:PTD) Martin Kriewaldt
Slide 21: Risk management – key risks
Risk management – key risks For personal use only Risk to Secondary Lymphoedema Opportunity Major clinical trials Bilateral lymphoedema approaches Reimbursement & Regulatory Strategies Securing necessary further FDA Approvals Gaining reimbursement coding and coverage Intellectual Prope
Slide 22: Conclusion
Conclusion For personal use only Business commercializing product range Market entry strategy facilitated by: Building global distribution Regulatory – first cleared device for Lymphoedema Reimbursement - applying for category one CPT code Building higher claims to limit competition and