30 th March 2009 ASX RELEASE - INVESTOR PRESENTATION

Transcription

1 30 th March 2009 ASX : IPD ASX RELEASE - INVESTOR PRESENTATION ImpediMed Limited wishes to advise that CEO Greg Brown is undertaking an investment roadshow visiting both Australian and US based institutional investors and will use the attached presentation to introduce the company. Phil Auckland CFO & Company Secretary About ImpediMed ImpediMed Ltd. is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphoedema. Pre-operative clinical assessment in breast cancer survivors, before the onset of symptoms, may prevent the condition from becoming a lifelong management issue and thus improve the quality of life of the cancer survivor. ImpediMed had the first medical device with an FDA clearance in the United States to aid health care professionals in the clinical assessment of secondary lymphoedema of the arm in female breast cancer patients. For more information, visit.

2 ImpediMed Limited Surviving cancer without compromising lifestyle

3 Safe Harbor Forward Looking Statements Certain sections of this presentation contain forward-looking statements which are based on management s expectations, estimates, projections and assumptions. Words such as expects, anticipates, plans, believes, scheduled, estimates and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, aircraft production, deliveries and backlog stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors. All forward-looking statements speak only as of the date of this presentation. All subsequent written and oral forward-looking statements attributable to the company or any person acting on the company s behalf are qualified by the cautionary statements in this section. Except as may be required by applicable law, the company undertakes no obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this presentation. ImpediMed L-Dex devices are not intended to diagnose or predict lymphedema of an extremity. L-Dex is a trademark of ImpediMed. Please review financial releases on the company s website ( for a complete listing of risk factors.

4 Overview Commercial company with recent FDA cleared & launched point of care diagnostic device for lymphedema Currently listed on the Australian Stock Exchange (fully diluted market cap of ~US$40mm) Current shareholders include Starfish Ventures ORBIS Macquarie Versant Ventures Internationally experienced management team

5 Investment Highlights Lymphedema represents a large & underserved market Multi-hundred million dollar annual consumables market opportunity ImpediMed has the first cleared technology to enable pre-emptive p care Proven prevention of lymphedema progression with simple intervention Over a decade of clinical evidence & peer reviewed science Major regulatory requirements in place (first FDA cleared device) Miscellaneous code private coverage with clear path to category 1 code Strong intellectual property protection

6 What is Lymphedema? Lymphatics - circulatory system for immunity & removal of cellular waste Lymphedema - breakdown of the lymphatic's where transport capacity fails Presently diagnosed when patients can already have irreversible changes Painful, lifelong condition - no cure & adversely affects quality-of-life life Successful treatment can occur with early detection (inexpensive sleeve) < Stage 2 Irreversible Stage 3 > Lymphostatic Elephantiasis

7 Lymphedema Incidence Rates Incidence of Lymphedema in Cancer Survivors US breast cancer incidence 240,000 cases/year US Breast cancer survivors 2.4 million US pelvic cancer incidence >450,000 cases/year Women s cancers, prostate, testicular, colon See reference information at end of presentation

8 Our Solution -Early Detection, Early Intervention e

9 Early Diagnosis and Treatment Results in Better Outcomes 5 year prospective NIH study Conducted at National Naval Med Center NIH and Navy IRB oversight Utilized a standardize metric for assessment of total arm volume not BIS Breast cancer patients all pre-operatively base-lined Evaluated at 1, 3, 6, 9 and 12 months 43 (22%) identified with sub-clinical lymphedema Intervention with off-the-shelf compression sleeve (4.4 wks ave.) All 43 reverted statistically back to a pre-surgical baseline Preoperative assessment enables the early diagnosis and successful treatment of lymphedema Gergich N, Washington F, Pfalzer L, Soballe P and McGarvey C, Cancer, June 2008, Vol 112, pp

10 ImpediMed Enables the New Clinical Paradigm Surgeon baselines patient misc. code Surgeon / Oncologist risk assessment misc. code High risk patient homecare - therapist L-Dex XCA $500 - $1000 Device consumables of $150-$300 per year Cancer Diagnosis Breast Pelvic Lymphoma Melanoma Every 3 months For the first 2 years High Risk Low Risk Low risk patient primary care physician L-Dex U400 $25 -$45 cost per reading IPD consumable ~ $150 - $300 reimbursed result

11 Positive Reimbursement Environment Women s Health and Cancer Rights Act of 1998 requires coverage of lymphedema care (HR 4328 Public Law ) Similar laws in 22 states Patient Advocacy Foundation (PAF) Providing reimbursement hotline support Currently surgeon/oncologist utilize miscellaneous codes Private payer coverage only - miscellaneous code for miscellaneous lymphedema study Average reimbursement payment of $150-$300 Targeting technology based category 1 code November 2009 Managed care - lobbying coverage CMS

12 Positive Reimbursement Environment Requirements for category 1 code technology specific BIS Need an FDA clearance for a BIS device (completed) Need to show it is billed on a miscellaneous code and that no other code is available (completed) Need 5 years of US peer reviewed science validating the technology (we feel this is now in place) Need professional society support from the key societies that sit on the AMA coding committee (working with key professional society s) Need to demonstrate widespread adoption (targeting greater than 100 users of the technology)

13 Bioimpedance Spectroscopy (BIS) BIS technology directly measures the extracellular fluid At low frequency At high frequency Cell membrane Intercellular fluid Extracellular fluid ImpediMed s BIS Technique 10 years of peer reviewed science on earlier detection Passes low-frequency of current through the body - harmless, painless Measures the impedance to the flow of current Amount of resistance related to fluid levels

14 Lymphedema Current Detection Methods and Limitations Current detection methods Tape measure Limitations May not detect until lymphedema is irreversible Non-FDA approved Archimedes method water displacement Perometer Measures only total volume change Subjective, j non-standard measures No indication for ancillary swelling Up to 35% standard deviation Time consuming

15 BIS is Superior to All Other Detection Methods Assessment and Monitoring o Tools Bioimpedance Symptom assessment Archimedes Tape measure Perometer Sensitivity Specificity Quantification Ease of use Time to measure Portability Evidence based YES NO YES YES YES BISissuperiortoallmethodsinnearlyevery superior in nearly every category

16 Commercial & Regulatory Status L-Dex U400 Single channel BIS device FDA cleared October 2008 Clinical assessment for unilateral lymphedema of the arm Uni-Leg submission mid CY2009 Over 10 years of peer reviewed science built on BIS L-Dex UB500 Multiple channel BIS device FDA targeting unilateral Oct. 09 Clinical assessment for uni & bilateral lymphedema of arm/leg Proprietary consumables Active electrode ect system

17 Business Model L-Dex U400 Place L-Dex devices in surgeons office free of charge Price per test of US$25 - $45 If a surgeon enrolls 8 new patients per month and is testing patients quarterly over the first two years, the placement will build to a monthly test volume of 64 tests L-Dex UB500 Estimated to sell for $24.5K each Consumable revenue of $25 - $45 per reading (volume dependant)

18 Intellectual Property Strong Patent Portfolio 12 patent families Filed internationally Covers BIS technology and consumable approach Key Trademarks Key brands and initiatives trademarked L-Dex Know your L-Dex

19 Focused Launch Strategy Physicians initially targeting 5000 specialist breast surgeons Building the sales force from 4 reps to 40 reps Increase technical/training staff ASBS sponsored registry Patients Enrollment program all breast cancer patients offered a free baseline test through the installed base Know your L-Dex US wide programs with Komen Race for the Cure Major media program around lymphedema and enrollment program Payers Managed care team Specialist consultants for Category 1 code submission CMS coverage RUC process

20 ImpediMed s Technology Benefits all Parties Physicians haven t had a realistic option previously now have a reliable, easy to use predictive tool; profitable for their practices Patients common fear given incidence/unsightliness, ability to have some control (predict/prevent) is meaningful Payors lymphedema treatment e t is expensive, e, this represents ese an inexpensive preventative measure (coupled with an inexpensive existing preventative treatment) Reactive care the costs of managing a patient with breast cancer related lymphoedema (BCRL) were significantly higher (in the range of $US14,877 to $US 23,167) over a two year period, than those breast cancer patients without lymphoedema Incidence, Treatment Costs, and Complications of Lymphedema After Breast Cancer Among Women of Working Age: A 2-Year Follow-Up StudyYa-Chen Y Tina Shih, Ying Xu, Janice N. Cormier, Sharon Giordano, Sheila H. Ridner, Thomas A. Buchholz, George H. Perkins, Linda S. Elting JCO Mar : doi: /jco

21 Operations US facilities - San Diego US operations/headquarters t 15 employees 7 employees presently in sales, marketing Australian facilities- Brisbane 10 employees (R&D, accounts, ROW S&M etc.) Manufacturing will be split between Australia and US

22 Recent Financials As reported in Australian Dollars ($000) $K AU 2H 2008 USD (0.65) Revenue ,018 Profit from continuing opns (7,750) (5,037) EBITDA (7,417) (4,821) Current assets 7,685 4,995 Current liabilities (2,151) (1,398) Debt 0 0 Average US$ exchange 0.909:1 in 2008 Today US$ exchange 0.65:1 in 2009

23 Ownership Profile Public Funds % of Ownership ORBIS 14.8% Macquarie 6.1% Other institutional investors 9.0% Venture Capital Starfish Ventures 26.9% Versant Ventures 5.7% Management 10.1% Shares outstanding 90.2m, options outstanding 17.9m WAEP 78 cents

24 Investment Highlights Lymphedema represents a large & underserved market Multi-hundred million dollar annual consumables market opportunity ImpediMed has the first cleared technology to enable pre-emptive p care Proven prevention of lymphedema progression with simple intervention Over a decade of clinical evidence & peer reviewed science Major regulatory requirements in place (first FDA cleared device) Miscellaneous code coverage with clear path to category 1 code Strong intellectual property protection

25 ImpediMed Thank you ImpediMed, Inc: ASX:IPD

26 Reference Information 1. Warren A, Brorson H, Borud L, and Slavin S, Lymphedema: A Comprehensive Review, Annals of Plastic Surgery Volume 59, Number 4, Francis WP, Abghari P, Du W, Rymal C, Suna M, Kosir MA. Improving surgical outcomes: standardizing di i the reporting of incidence id and severity of acute lymphedema after sentinel lymph node biopsy and axillary lymph node dissection. Am J Surg 2006;192(5): Available from cmd=retrieve&db=pubmed&dopt=citation &list_uids= nih.gov/entrez/query.fcgi?cmd=retrieve&db= PubMed&dopt=Citation&list_uids= Armer J, Fu MR, Wainstock JM, Zagar E, Jacobs LK. Lymphedema following breast cancer treatment, including sentinel lymph node biopsy. Lymphology 2004;37(2): Available from PM: Leidenius M, Leivonen M, Vironen J, von Smitten K. The consequences of long-time arm morbidity in node-negative breast cancer patients with sentinel node biopsy or axillary clearance. J.Surg.Oncol. 2005;92(1): Available from PM: Langer I, Guller U, Berclaz G, Koechli OR, Schaer G, Fehr MK, et al. Morbidity of sentinel lymph node biopsy (SLN) alone versus SLN and completion axillary lymph node dissection after breast cancer surgery: a prospective Swiss multicenter study on 659 patients. Ann Surg 2007;245(3): Available from Retrieve&db=PubMed& dopt=citation&list_uids= < entrez/query.fcgi?cmd= Retrieve&db=PubMed&dopt=Citation&list_uids= > 6. Clark B, Sitzia J, Harlow W. Incidence and risk of arm oedema following treatment for breast cancer: a three-year follow-up study. QJM. 2005;98(5): Available from PM: Umberto Veronesi, M.D., Giovanni Paganelli, M.D., Giuseppe Viale, F.R.C.Path., Alberto Luini, M.D., Stefano Zurrida, M.D., Viviana Galimberti, M.D., Mattia Intra, M.D., Paolo Veronesi, M.D., Chris Robertson, Ph.D., Patrick Maisonneuve, Eng., Giuseppe Renne,M.D.,Concetta, De Cicco, M.D., Francesca De Lucia, M.D. and Roberto Gennari, M.D.: A Randomized Comparison of Sentinel-Node Biopsy with Routine Axillary Dissection in Breast Cancer. N Engl J Med Volume 349;6: August 7, Haid et al: Morbidity of Breast Cancer Patients Following Complete Axillary Dissection or Sentinel Node Biopsy Only: A Comparative Evaluation. Breast Cancer Research and Treatment Volume 73, Number 1 / May, Gergich N, Pfalzer L, Soballe P, Washington F. and McGarvey C: Preoperative Assessment Improves early Diagnosis and Treatment of Lymphedema Poster, Society of Surgical Oncology, Washington DC, Mar 2007.[Poster] Gergich N, Pfalzer L, Soballe P, Washington F. and McGarvey C: Early Diagnosis and Treatment Intervention for Lymphedema. World Confederation of Physical Therapy: Vancouver, British Columbia. June [poster]

27 Reference Information (Cont) 11. Armer JM, Stewart BR. A comparison of four diagnostic criteria for lymphedema in a post-breast cancer population. Lymphat Res Biol 2005;3(4): Available from < cmd=retrieve&db= PubMed&dopt=Citation&list_uids= > 12. Box R, Hildegard M, Bullock-Saxton J, and Furnival C: Physiotherapy after breast cancer surgery: results of a randomized study to minimise lymphoedema. Breast Cancer Research and Treatment 75: 51-64, Johansson K, Ohlsson K, Ingvar C, Albertsson M, Ekdahl C. Factors associated with the development of arm lymphedema following breast cancer treatment: a match pair case-control study. Lymphology 2002;35(2): Available from PM: The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology 2003;36(2): Harris, Susan R., Hugi, Maria R., Olivotto, Ivo A., Levine, Mark Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema CMAJ : Werngren-Elgstrom M, Lidman D. Lymphedema of the lower extremities after surgery and radiotherapy for cancer of the cervix. Scand J Plast Reconstr Surg Hand Surg 1994;28: Nunns D, Williamson K, Swaney L, et al. The morbidity of surgery and adjuvant radiotherapy in the management of endometrial carcinoma. Int J Gynecol Cancer 2000;10: Fujiwara K, Kigawa J, Hasegawa K, et al. Effect of simple omentoplasty and omentopexy in the prevention of complications i after pelvic li lymphadenectomy. Int J Gynecol Cancer 2003;13: Carlson J, Kauderer J, Walker J, Gold M, O Malley D, Tuller E, Clarke-Pearson D. Phase III trial of Tisseel to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. The 38th Annual Meeting on Women s Cancer. March 3-7, San Diego, CA. Abstract #228.