Given Imaging Announces Reimbursement Approval for Capsule Endoscopy in Australia
Yoqneam, Israel -- September 18, 2003 -- Given Imaging Ltd. (NASDAQ: GIVN) announced today that Australia’s minister for Health and Ageing, The Hon. Senator Kay Patterson has approved reimbursement for capsule endoscopy.
Australia’s Medical Services Advisory Committee based its decision on studies showing the safety, effectiveness and cost effectiveness of capsule endoscopy. The M2A® capsule endoscope is approved for use in cases of obscure gastrointestinal bleeding in patients following previous colonoscopy and upper gastrointestinal endoscopy without identifying the bleeding source. The approval was endorsed on September 7, 2003 and the implementation stage is now in progress.
"After extensive review and assessment, we are delighted that the Australian Minister for Health and Ageing has recognized the importance of capsule endoscopy. Patients throughout Australia will be able to benefit from the Given® System’s ability to aid in more definitive diagnoses of Obscure Gastrointestinal Bleeding and disease" said Assoc. Prof. Paul Desmond, council member of the Gastroenterological Society of Australia.
"Australia with a population of over 19 Million is one of a growing number of countries that have approved reimbursement of capsule endoscopy for their entire population. This coverage reflects the respective health ministries’ acceptance of the vital role that capsule endoscopy plays in diagnosing small bowel disorders. Approval for reimbursement in Australia comes one month prior to The Australian Gastroenterology Week in Cairns, Queensland October 7-10, and will greatly enhance the many clinical oral and poster presentations at this important conference," said Gavriel D. Meron, President and CEO of Given Imaging Ltd.
This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues, and our future profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission.