Impedimed Limited · ASX:IPD
Impedimed — Shareholder Meeting (April 2008)
18 slides from Impedimed's shareholder meeting presentation, Apr 21, 2008
Slide 1: EGM Presentation: ImpediMed executes plans to support major US roll out
ASX : IPD 21 April 2008 For personal use only ASX RELEASE EGM Presentation: ImpediMed executes plans to support major US roll out 3rd quarter 2008 ImpediMed Limited provides the attached company update to be presented to shareholders at today’s EGM at 4:00pm 21st April 2008. The presentation updates
Slide 2: Update Presentation – EGM 21st April 2008
Update Presentation – EGM 21st April 2008 For personal use only ImpediMed Limited Surviving cancer without compromising lifestyle
Slide 3: ImpediMed targeting fluid status market
ImpediMed targeting fluid status market For personal use only 1.Lymphoedema/Oedema markets Breast cancer Pelvic cancers Venous insufficiency Fluid Status Market $5 B device $0.5 B consumables 2.Dialysis market 3. Imaging markets Dry D mass market k t DEXA suppliers li Cachexia management
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? Groundbreaking validated technology First to market with FDA clearance Ad Advanced d reimbursement i b t strategy t t Excellent independent clinical validation 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 UB500 Over moulded cable strain relief Clinical Cli i l routine ti device d i designed d i d for healthcare professionals ImpediMed is targeting 510K specials to U400 for Dec 08 Commercial launch is targeted for 2009
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. NIH new clinical paradigm - Pre-emptive care
4. NIH new clinical paradigm - Pre-emptive care For personal use only Surgeon Surgeon / High Risk Patient – Homecare Baselines Patient Oncologist $500 - $1000 Device 2 X Misc Codes Risk Assessment |__|__|__|__|__|__|__|__|__|__|__| 2 X Misc code Consumables of $120-$240 $120 $240 per year Cancer Hig
Slide 13: 5. Reimbursement – targeting miscellaneous codes until category one code is available
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: 5. Reimbursement – cat. one code submission Oct
5. Reimbursement – cat. one code submission Oct 08 For personal use only NIH publication showing the clinical benefits of early detection – estimate June 2008 U400 FDA clearance – XCA (denovo) – Lodged March 20th Clearance C ea a ce anticipated a t c pated p prior o to code sub submission ss
Slide 15: 6. Estimated market potential – significant potential
6. 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 p opportunities pp Fluid status monitoring/imaging
Slide 17: 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 quantitative the difference in abdominal fatness Will be b a 1 minute i
Slide 18: Conclusion
Conclusion For personal use only Commercializing product range now – first mover advantage Market entry strategy facilitated by: Building global clinical validation through key institutes Regulatory – the first cleared device for Lymphoedema Reimbursement - applying for category one CPT co