IMPEDIMED LIMITED — Capital/Financing Update 2010

Mar 7, 2010

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8th March, 2010

PRESS RELEASE

BREAKTHROUGH REIMBURSEMENT CODING IN THE UNITED STATES

American Medical Association (AMA) establishes a unique Category III CPT code for the use of Bioimpedance Spectroscopy (BIS) in the assessment of lymphoedema.

The American Medical Association has now established a unique Category III CPT code for the Bioimpedance Spectroscopy assessment of lymphoedema detection in both arms and legs. The Category III code, designated for emerging technologies, is expected to be published by 1 July, 2010, for use beginning 1 January, 2011.

“The use of a dedicated code for BIS will allow payers in the US to distinguish procedures that are otherwise grouped under a „miscellaneous‟ code. As a growing number of my colleagues are adopting L-Dex[®] technology in the management of their patients with breast cancer, a category specific code will facilitate clearer tracking of utilization and outcomes,” said Peter Beitsch M.D[1] ., a general surgeon from Dallas who submitted the code application to the AMA. He went on to say, “Using this new code supports the AMA‟s ruling to now allow clinicians and payers to track, and to better understand, the utilization and value of Bioimpedance Spectroscopy,” Dr Beitsch added.

CPT codes accurately describe medical services performed in the US, and are used to communicate to payers for billing purposes. Prior to the establishment of this Category III CPT code, physicians and hospitals using ImpediMed‟s L-Dex technology have had to use a non-specific, miscellaneous CPT code. This miscellaneous CPT code can be used for billing many different medical procedures associated with the lymphatic system and it is not specific to lymphoedema detection. Due to the multiplicity of the miscellaneous code, additional documentation regarding the medical necessity of L-Dex readings was required to accompany each and every claim. This, with a manual claims review process by insurance companies, often led to payment decisions that have taken months to approve or decline.

“Physicians need an accurate and objective tool to assess and monitor the early changes in the limbs that lead to the development of lymphoedema. Today, we can institute preventative and more cost effective measures by detecting and treating lymphoedema at its earliest stages. Simply, BIS provides better outcomes for patients, while delivering better cost effectiveness for payers,” said Dr Beitsch, adding, “This new code will provide a pathway for greater physician and patient access to this advanced BIS technology. In addition, I see the use of BIS expanding to help prevent lymphoedema in melanoma patients.”

Unlike a Category I CPT code, the new code will have the added benefit of not having a specific payment amount associated with it and payers will continue to make individual decisions regarding payment values and protocols based on the excellent health economic data available to demonstrate the benefits of pre-emptive care.

“We are confident of maintaining an attractive payment for healthcare providers with the new Category III CPT code. In addition, we can now directly build and track the payment and coverage of our technology by each payer with this code. This will help facilitate the adoption of BIS technology going forward as we can now show the doctors directly which payers will cover their patients and how they will be remunerated. The key focus now is on building coverage for this new code through the major health care payers for the US market. We will track and announce the growth in covered lives as we build this critical component in effective reimbursement for L-Dex testing," said Greg Brown, Chief Executive Officer of ImpediMed.

“The successful use of a technology specific code in breast cancer is now well recognised after the success of electronic brachytherapy. Good coverage has been built around this Category III CPT code with major US healthcare payers. I see this as a major step forward in helping to drive the adoption of pre-emptive care in the US market,” said Walton Taylor M.D.[2] , a long term user and supporter of L-Dex technology. ”The great thing about the L-Dex test is that it now allows surgeons and oncologists to prospectively manage the risk of lymphoedema and identify it early, when it can be most cost effectively treated. Over the last year and a half of use, my experience has corroborated the results seen in the NIH study and published in Cancer[3] . One hundred percent of the patients I have identified with lymphoedema at a subclinical stage through L-Dex testing have been treated successfully, returning them to pre-surgical baselines,” said Dr. Taylor.

ImpediMed‟s L-Dex devices are the first FDA, CE and TGA cleared devices that offer simple point of care, standardised and objective metrics to aid in the clinical assessment of lymphoedema. They enable medical professionals to provide preoperative clinical assessments and ongoing monitoring of patients for the early signs of lymphoedema. This allows early, simple, cost effective treatment which can assist in preventing the progression of lymphoedema to irreversible forms, helping to improve the quality of life of patients while easing the substantial financial burden on patients and governments.

1. Dr. Peter Beitsch is board certified in general surgery, but has a special interest in cancer surgery. He is a Fellow of both the Society of Surgical Oncology and the American College of Surgeons.

2. Dr. Walton Taylor is a board certified surgeon with extensive experience in the diagnosis and treatment of breast cancer. He is a Fellow of the American College of Surgeons and member of the American Society of Breast Surgeons.

1. Stout-Gergich N, Washington F, Pfalzer L, Soballe P and McGarvey C , Preoperative assessment enables the early diagnosis and successful treatment of lymphedema., Cancer, Vol 112, pp 2809-2819, June 2008.

ENDS

For further information contact: Greg Brown CEO ImpediMed Limited T: 61-7-3860-3700; Mobile/Cell: Aus. 0408281127; Intl. +61408281127

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 has 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.