SOURCE: Given Imaging

May 04, 2006 08:30 ET

Florida Medicare to Reimburse for PillCam™ ESO on Case-by-Case Basis

First Formal Statement From Third-Party Payor

YOQNEAM, ISRAEL -- (MARKET WIRE) -- May 4, 2006 -- Given Imaging Ltd. (NASDAQ: GIVN) today announced that Florida Medicare, administered by First Coast Service Options with approximately 2.8 million beneficiaries, will review claims for PillCam ESO for the esophagus on a case-by-case basis for individual consideration of payment. This is the first statement from a third-party payor regarding reimbursement for esophageal capsule endoscopy.

"This development provides Florida Medicare patients access to a superior diagnostic tool for esophageal disease," said Dr. Ira Shafran of Shafran Gastroenterology Center in Winter Park, Florida. "It also provides an attractive alternative to invasive gastroenterological procedures for patients who cannot undergo sedation such as those who are cirrhotic."

"We applaud First Coast Service Options for being among the first in the country to recognize the value that PillCam ESO holds in detecting diseases of the esophagus such as Barrett's esophagus, varices and esophageal cancer," said Mark Gilreath, SVP, Global Marketing at Given Imaging.

The updated guidelines are retroactive to March 23, 2006. Florida physicians seeking Medicare reimbursement for esophageal capsule endoscopy should use CPT code 91110 with modifier 52. For more information visit

About Given Imaging

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam™ video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the Given® Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam SB capsule is a naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 300,000 patients worldwide. The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing, and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain, and Australia. For more information, visit

This press release contains forward-looking statements about Given Imaging, including projections about our business and our future revenues, expenses and 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 impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission.

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