ASX RELEASE - INVESTOR PRESENTATIONinvestors.impedimed.com/...presentation_roadshow.pdfASX RELEASE - INVESTOR PRESENTATION ImpediMed Limited wishes to advise that CEO Greg Brown is

30th March 2009 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. www.impedimed.com.

ASX : IPD

ImpediMed LimitedImpediMed LimitedSurviving cancer withoutSurviving cancer withoutSurviving cancer without Surviving cancer without

compromising lifestylecompromising lifestyle

Safe Harbor

Forward Looking Statements

Certain sections of this presentation contain forward-looking statements which are based onCertain 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 segmentwhich 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 areguarantees 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.

ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle

Please review financial releases on the company’s website (www.impedimed.com) for a complete listing of risk factors.

Overview

Commercial company with recent FDA cleared & launched point of Commercial company with recent FDA cleared & launched point of care diagnostic device for lymphedema

Currently listed on the Australian Stock Exchange (fully diluted k f S$ 0 )market cap of ~US$40mm)

Current shareholders include • Starfish Ventures• Starfish Ventures • ORBIS• Macquarie• Versant Ventures

Internationally experienced management team


Investment Highlights

Lymphedema represents a large & underserved markety p p g

Multi-hundred million dollar annual consumables market opportunity

ImpediMed has the first cleared technology to enable pre-emptive carep gy p p

Proven prevention of lymphedema progression with simple intervention

Over a decade of clinical evidence & peer reviewed scienceOver 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 codeMiscellaneous code private coverage with clear path to category 1 code

Strong intellectual property protection


What is Lymphedema?

Lymphatics - circulatory system for immunity & removal of cellular wastey p y y y 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 Painful, lifelong condition - no cure & adversely affects quality-of-life Successful treatment can occur with early detection (inexpensive sleeve)

< Stage 2 Irreversible

Stage 3 > Lymphostatic Elephantiasis


Lymphedema Incidence Rates

Incidence of Lymphedema in Cancer Survivors

• US breast cancer incidence – 240,000 cases/year• US Breast cancer survivors – 2 4 millionUS Breast cancer survivors 2.4 million

• US pelvic cancer incidence – >450,000 cases/year• Women’s cancers, prostate, testicular, colon

ImpediMed Ltd - Surviving Cancer Without Compromising LifestyleSee reference information at end of presentation

Our Solution -Early Detection, Early Interventione e o


Early Diagnosis and Treatment Results in Better Outcomesin Better Outcomes

5 year prospective NIH study Conducted at National Naval Med Center

NIH d N IRB i ht 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• 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 lymphedemaGergich N, Washington F, Pfalzer L, Soballe P and McGarvey C, Cancer, June 2008, Vol 112, pp 2809-2819

ImpediMed Enables the New Clinical Paradigm

High risk patient – homecare - therapist

Surgeon / Oncologist

risk assessment

Surgeon baselines patient

misc. code

L-Dex XCA

|__|__|__|__|__|__|__|__|__|__|__|

$500 - $1000 Device

Cancer Diagnosis

misc. code$ $

consumables of $150-$300 per year

High RiskCancer Diagnosis

Breast Pelvic

Lymphoma

Every 3 months

High Risk

Melanoma

For the first 2 years

Low risk patient – primary care physician

Low Risk

yearsL-Dex U400

_____|____________|_____

$25 -$45 cost per reading IPD consumable


~ $150 - $300 reimbursed result

Positive Reimbursement Environment

Women’s Health and Cancer Rights Act of 1998 requires coverage of g q glymphedema care (HR 4328 Public Law 105-277)

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 studylymphedema study

Average reimbursement payment of $150-$300

Targeting technology based category 1 code November 2009 Targeting technology based category 1 code November 2009

Managed care - lobbying coverage CMS


Positive Reimbursement Environment

Requirements for category 1 code – technology specific BIS 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)(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)


Bioimpedance Spectroscopy (BIS)

BIS technology directly measures the extracellular fluidAt 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


Measures the impedance to the flow of current Amount of resistance related to fluid levels

Lymphedema – Current Detection Methods and Limitationsand Limitations

LimitationsCurrent detection methods

Tape measureMay not detect until lymphedema is irreversible

Non-FDA approved

Measures only total volume

Archimedes method –water displacement

ychange

Subjective, non-standard jmeasures

No indication for ancillary

Perometer

swelling

Up to 35% standard deviation

ImpediMed Ltd - Surviving Cancer Without Compromising LifestyleTime consuming

BIS is Superior to All Other Detection Methods

Assessment and Monitoring Toolsss ss d o o g oo s

Bioimpedance Symptom assessment Archimedes Tape measure Perometer

Sensitivity

Specificity

Quantification

Ease of use

Time to measureTime to measure

Portability

Evidence based YES YES YES YESNO

BIS is superior to all methods in nearly every category


BIS is superior to all methods in nearly every category

Commercial & Regulatory Status

L-Dex U400 Single channel BIS device FDA cleared October 2008 Clinical assessment for uni-

lateral lymphedema of the arm Uni-Leg submission mid CY2009 Over 10 years of peer reviewed y p

science built on BIS

L-Dex UB500 Multiple channel BIS device FDA targeting unilateral Oct. 09 Clinical assessment for uni & bi-Clinical assessment for uni & bi

lateral lymphedema of arm/leg Proprietary consumables Active electrode system


ct e e ect ode syste

Business Model

L-Dex U400L-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)


Intellectual Property

Strong Patent Portfolio

12 patent families

Filed internationallyy

Covers BIS technology and consumable approach

Key Trademarks

Key brands and initiatives trademarkedKey brands and initiatives trademarked

L-Dex

Know your L-DexKnow your L Dex


Focused Launch Strategy

Physicians – initially targeting 5000 specialist breast surgeons Physicians initially targeting 5000 specialist breast surgeons Building the sales force from 4 reps to 40 reps Increase technical/training staff

d ASBS sponsored registry Patients

Enrollment program – all breast cancer patients offered a free baseline p g ptest 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 Major media program around lymphedema and enrollment program

Payers Managed care team Specialist consultants for

Category 1 code submission CMS coverage


g RUC process

ImpediMed’s Technology Benefits all Partiesp gy

Physicians – haven’t had a realistic option previously – now havePhysicians 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 toPatients common fear given incidence/unsightliness, ability to have some control (predict/prevent) is meaningful

Payors – lymphedema treatment is expensive, this represents an ayo s y p ede a t eat e t s e pe s e, t s ep ese ts ainexpensive 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 cancer23,167) over a two year period, than those breast cancer patients without lymphoedema”

Incidence, Treatment Costs, and Complications of Lymphedema After Breast Cancer A W f W ki A A 2 Y F ll U St d Y Ch Ti Shih Yi X J i


Among Women of Working Age: A 2-Year Follow-Up StudyYa-Chen Tina Shih, Ying Xu, Janice N. Cormier, Sharon Giordano, Sheila H. Ridner, Thomas A. Buchholz, George H. Perkins, Linda S. Elting JCO Mar 16 2009: doi:10.1200/JCO.2008.18.3517

Operations

US f iliti S Di US ti /h d t US facilities - San Diego US operations/headquarters 15 employees

7 employees presently in sales, marketing 7 employees presently in sales, marketing

Australian facilities- Brisbane 10 employees (R&D, accounts, ROW S&M etc.)

M f t i ill b lit b t A t li d US Manufacturing will be split between Australia and US


Recent Financials

As reported in Australian Dollars ($000)

$K AU 2H 2008 USD (0.65)

Revenue 1567 1 018Revenue 1567 1,018

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 0Debt 0 0


•Average US$ exchange 0.909:1 in 2008 •Today US$ exchange 0.65:1 in 2009

Ownership Profile

% of OwnershippPublic Funds

ORBIS 14.8%

Macquarie 6.1%

Other institutional investors 9 0%Other institutional investors 9.0%

Venture Capital

Starfish Ventures 26.9%

Versant Ventures 5.7%

Management 10.1%

ImpediMed Ltd - Surviving Cancer Without Compromising LifestyleShares outstanding 90.2m, options outstanding 17.9m WAEP 78 cents

Investment Highlights

Lymphedema represents a large & underserved markety p p g

Multi-hundred million dollar annual consumables market opportunity

ImpediMed has the first cleared technology to enable pre-emptive carep gy p p

Proven prevention of lymphedema progression with simple intervention

Over a decade of clinical evidence & peer reviewed scienceOver 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 codeMiscellaneous code coverage with clear path to category 1 code

Strong intellectual property protection


ImpediMedThank you

ImpediMed, Inc: [email protected]

www.L-Dex.comASX:IPD


ASX:IPD

Reference InformationReference Information1. Warren A, Brorson H, Borud L, and Slavin S, Lymphedema: A Comprehensive Review, Annals of Plastic Surgery • Volume 59, Number 4,2007

2 F i WP Ab h i P D W R l C S M K i MA I i i l t t d di i th ti f i id d2. Francis WP, Abghari P, Du W, Rymal C, Suna M, Kosir MA. Improving surgical outcomes: standardizing the reporting of incidence and severity of acute lymphedema after sentinel lymph node biopsy and axillary lymph node dissection. Am J Surg 2006;192(5):636-9. Available from http://www.ncbi. .nlm.nih.gov/entrez/query.fcgi? cmd=Retrieve&db=PubMed&dopt=Citation &list_uids=17071198 http://www.ncbi.nlm. nih.gov/entrez/query.fcgi?cmd=Retrieve&db= PubMed&dopt=Citation&list_uids=17071198

3. Armer J, Fu MR, Wainstock JM, Zagar E, Jacobs LK. Lymphedema following breast cancer treatment, including sentinel lymph nodebiopsy. Lymphology 2004;37(2):73-91. Available from PM:15328760

4. 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):23-31. Available from PM:16180231

5. 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 Surgcompletion axillary lymph node dissection after breast cancer surgery: a prospective Swiss multicenter study on 659 patients. Ann Surg 2007;245(3):452-61. Available from http://www.ncbi..nlm.nih.gov/entrez/query.fcgi?cmd= Retrieve&db=PubMed&

dopt=Citation&list_uids=17435553 <http://www.ncbi.nlm.nih.gov/ entrez/query.fcgi?cmd=

Retrieve&db=PubMed&dopt=Citation&list_uids=17435553>

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):343-48. Available from PM:15820971

7. 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, , , , , , pBiopsy with Routine Axillary Dissection in Breast Cancer. N Engl J Med Volume 349;6:546-553 August 7, 2003

8. 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, 2002

9. 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, 15-18 Mar 2007.[Poster] http://www.wcpt.org/abstracts2007/Abstracts/29-05.htm

10. 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 2007. [poster]

Reference Information (Cont)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):208-17. Available from ; ( )http://www.ncbi..nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16379589 <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16379589>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, 200213. Johansson K, Ohlsson K, Ingvar C, Albertsson M, Ekdahl C. Factors associated with the development of arm lymphedema followingbreast cancer treatment: a match pair case-control study. Lymphology 2002;35(2):59-71. Available from PM:1208105314. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology 2003;36(2):84-91.15. Harris, Susan R., Hugi, Maria R., Olivotto, Ivo A., Levine, Mark Clinical practice guidelines for the care and treatment of breast cancer:

h d11. Lymphedema CMAJ 2001 164: 191-19916 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;28:289-93.17. 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;10:233-8.18 F ji K Ki J H K l Eff f i l l d i h i f li i f l i18. Fujiwara K, Kigawa J, Hasegawa K, et al. Effect of simple omentoplasty and omentopexy in the prevention of complications after pelvic lymphadenectomy. Int J Gynecol Cancer 2003;13:61-6.19. 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, 2007. San Diego, CA. Abstract #228.


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ASX RELEASE - INVESTOR PRESENTATIONinvestors.impedimed.com/...presentation_roadshow.pdfASX RELEASE - INVESTOR PRESENTATION ImpediMed Limited wishes to advise that CEO Greg Brown is