IMPEDIMED LIMITED — AGM Information 2009

Nov 22, 2009

Monday 23rd November, 2009

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ASX : IPD
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PRESS RELEASE

IMPEDIMED REAFFIRMS COMPANY GROWTH PROSPECTS

At today‟s AGM, Chief Executive Officer, Greg Brown announced to shareholders that the company‟s progress around its US targeted reimbursement program, was positioning the company strongly, and building the basis of an attractive long term and sustainable business model for shareholders.

Mr Brown said, „The L-Dex[®] U400 is the only FDA cleared medical device available on the market today to aid medical providers in the clinical assessment of unilateral lymphoedema of the arm in female breast cancer patients. This clearance allows the technology to qualify for reimbursement for medical providers adopting practices targeted at prospective care models for cancer patients,‟ he added.

„This is a major step forward in the drive for the education and prevention of lymphoedema therefore assisting medical providers to diagnose and treat patients earlier to help prevent the progression of the disorder to irreversible stages,‟ Mr Brown added.

ImpediMed‟s Chairman, Mel Bridges was upbeat about the company‟s prospects for growth in the coming years, especially due to the progress being made around the public debate on prospective lymphoedema care and the building list of publications supporting the use of the L-Dex[®] technology for managing this important medical disorder in cancer patients.

„The company continues to target key cancer surgeons, oncologists and therapists throughout the world for helping to drive the change from a reactive care model to a pre-emptive care model for all cancer patients,‟ Mr Bridges said.

„We have received strong support from key US, European and Australian surgeons this year in relation to the adoption of ImpediMed‟s L-Dex[®] technology. The recent filing to the American Medical Association (AMA) of the application for a category one code was a major boost for increasing the chances of a successful code submission.

„With the building list of publications over the last twelve months, the body of evidence that supports the use of ImpediMed‟s Bioimpedance Spectroscopy (BIS) device for aiding in the clinical assessment of lymphoedema is significant. There is a wave of public debate right now in the US around lymphoedema management and the need for standardised objective metrics

driving evidence based medicine. Presently, ImpediMed has the only available FDA cleared device to help establish this requirement,‟ Mr Brown added.

Mr Brown went on to also say that the political debate in the US Senate at present is all around why advances in biomedical knowledge and technical innovation have not delivered marked improvements in health. There is a building debate that is focused on ensuring earlier adoption of new paradigms of care (like pre-emptive care) through the appropriate definition of evidence based medicine. It is argued that evidence based medicine is not limited to just randomised control studies. The debate in the Senate at present includes the need for consideration for the Sackett definition of evidence-based medicine. That is, „evidence based medicine is the integration of best research evidence with clinical expertise and patient values‟, (Sackett , et al 2001). The present Senate debate could be a positive opportunity for advancing coverage for ImpediMed in the US.

The company update presentation to be delivered at today‟s AGM is also attached to this release.

To learn more, please visit www.impedimed.com Greg Brown CEO +61- 408281127 Mel Bridges – Chairman +61- 413- 051-600

L-Dex[®] is a trademark of ImpediMed Limited.

“ L-Dex[® ] values that lie outside the normal range may indicate the early signs of lymphoedema and values that have changed +10 L-Dex units from baseline may also indicate early lymphoedema. The L-Dex scale is a tool to assist in the clinical assessment of lymphoedema by a medical provider. The L-Dex scale is not intended to diagnose or predict lymphoedema of an extremity”.

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, clinically assess secondary lymphoedema of the arm in female breast cancer patients. For more information, visit. www.impedimed.com.

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ImpediMed Limited
Surviving cancer without
compromising lifestyle
ImpediMed AGM
CEO Address
Greg Brown
Mobile 0408 281127
gregbrown@impedimed.com
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2009 Highlights
• Several new publications – JCO, Cancer, BCRT
Validation
• Possible ASBS registry & US leg trial
• First US cleared FDA device in October 2008
First Mover
• 65 L-Dex agreements – various stages of qualification
• Expanded BIS platform, lymphoedema & oedema
IP Protection • L-Dex [®] [-] building brand collateral
Fund raising • Year of the GFC – most successful year
Team • Building US team – Q&R, Managed Care, & sales
• Miscellaneous code-sporadic coverage, Cat 1 filed
Reimbursement
• New NC state law for coverage
ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle
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Targeting Multiple Fluid Status Markets

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Lymphoedema market Dialysis market
� Arms – mainly Breast cancer � Licensed by Fresenius
Current
Fluid Status Fluid Status
Market Market
Lymphoedema market Oedema market
� Legs – Pelvic cancers Future � Venous insufficiency (VI)
ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle
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Lymphoedema – Current Care & Diagnosis

• Photo (left) shows a 200 ml difference in limb volumes (stage 2)

• This is the point at which most lymphoedema is diagnosed today

• In most cases, at 200ml, irreversible changes have already occurred

• The gold standard for diagnosis today is still a bucket of water

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ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle
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Our Solution -Early Detection, Early Intervention

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Key Publication – Cancer May 2008

• Preoperative assessment enables the early diagnosis and successful treatment of lymphedema

• 5 year study assessing lymphedema in breast cancer (196 patients)

• Preoperative, 1, 3, 6, 9, and 12 month assessment post surgery

• 22% (43 patients) identified with sub-clinical lymphedema

• Publication has been well received by surgeons – now can help protect patients against lymphedema through pre-emptive care National Institutes of Health Run and Funded StudyImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle

Potential Healthcare Savings – Preemptive Care

MD Anderson/Vanderbilt Economic Study[11]

• 2 yr estimate of economic burden of breast cancer related lymphoedema (BCRL)

• “Psychosocial impact of lymphoedema has been described to be as distressing as the initial diagnosis of BC”

• “The matched cohort analysis demonstrated that the BCRL group had significantly higher medical costs (US$14,877 to US$23,167)”

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ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle
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Business Model

L-Dex U400

• Place L-Dex device free of charge –price/test of US $25 - $49

• L-Dex UB500

• Estimated to sell for $24.5K each with consumable cost of $25/reading (for purchased device)

• Consumable cost - $40 to $49 /reading (L-Dex lease of device)

• Estimated testing

• Surgeon who enrolls 10 new patients/month & is testing quarterly over the first 3 years, then placement will build to a monthly test volume of 120 tests

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Lymphoedema – Growing Acceptance Of Issue
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• Cancer 08 - reduced threat • Most dreaded sequeleae

• • For Breast cancer lymphoedema

• • Supports pre-emptive care

• ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle

Business Momentum

• 65 L-Dex agreements now in the US market

• Main focus has been key opinion leaders – top 50 surgeons

• Need to maintain & expand reimbursement to drive the model

• American Society of Breast Surgeons (ASBS)

• Key members now using the product

• Possible ASBS registry - potential to target up to 200 surgeons � Protocol discussions still ongoing

• Major Clinical trials

• US government funded leg trial for UB500

• Place Trial for breast cancer– Professor of surgery Nigel Bundred � Manchester, Guys, Derby, Pool, Bournemouth, Staffordshire � Study to establish best practice guidelines

• ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle

Reimbursement Environment

• Miscellaneous code coverage

• Women’s Health and Rights act 1998 – mastectomy only

• Twenty-one similar US state laws

• The North Carolina state bill was recently signed

  • “Every health benefit plan, as defined in G.S. 58-3-167, shall provide coverage for the diagnosis, evaluation, and treatment of lymphedema”

• The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) - need for standardised metric

• CMS coverage division – makes coverage decisions

• Blue Cross Blue Shields – good progress, considering internal codes for L-Dex[®] technology

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Category One Code Submission Criteria
Category One Code Submission Requirements
FDA clearance ����
Billed on a miscellaneous code; show that no other ����
code is available
> 5 years US peer reviewed science validating ��
technology
Professional society support ��
Demonstrate widespread adoption (targeting greater ���
than 100 users of technology)
Implications: Category One Code
• Will encourage broad medical provider adoption through coverage statements
• Technology specific code creates additional barriers to entry
Table is a synopsis of the key requirements to achieve a Category One Code for a medical device as
published by the American Medical Association. Further detail on Category One Code can be found
ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle at: http://www.ama-assn.org/ama/no-index/physician-resources/3882.shtml
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Why This Product Can Succeed

• This is breast cancer & don’t tell a patient lymphoedema is not an issue

• Strong data supports technology – 15 years of peer reviewed science

• Key thought leaders globally helping to drive change – preemptive care

• Payers want to decrease chronic care lymphoedema costs

• Federal law already in place for breast cancer, 22 state laws for breast

• States now passing legislation for compulsory coverage (NC, NY Bill filed)

• Docs make money – fills revenue hole from reduced brachytherapy

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New Products Drive Market Expansion

Status

• Beta site trials – US (GOG)

Pricing

• List price will be US $28,500

• � $25 per reading (Purchased) � $48 for L-Dex agreement • Locked in active electrode system •

• • Stand or wall mounted Patent protected • Retractable arm ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle

Senior Management Expansion

Don Myll CFO – San Diego

TheraTx (NASDAQ: THTX) co-founder, CFO, VP of Operations - Responsible for all financial and corporate support aspects as company grew from inception to over $400 million in revenue & 8,000 employees in 7 years Peggy Brooker VP of Global Finance – San Diego Ernst and Young Audit Partner (15 years), CFO company experience - over 20 years senior finance experience. GAP & IFRS experience

Alden Kay VP of Quality & Regulatory – San Diego Endocare, Inc., Visijet, Inc., Intramed Labs – over 20 years in quality and regulatory experience with medical devices ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle