SOURCE: Given Imaging

May 12, 2006 08:30 ET

Given Imaging's Agile™ Patency System Receives US Marketing Clearance

YOQNEAM, ISRAEL -- (MARKET WIRE) -- May 12, 2006 -- Given Imaging Ltd. (NASDAQ: GIVN) today announced that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the Agile Patency System which enables physicians to determine the presence of obstructions or strictures in the gastrointestinal tract through a dissolvable capsule. The Agile Patency Capsule will give physicians confidence that a PillCam™ video capsule will pass freely in a patient with known or suspected strictures.

Shoshana Friedman, Senior Vice President, Regulatory & Clinical Affairs of Given Imaging said, "This FDA clearance allows us to expand our market beyond the current patient population to include patients with suspected strictures that are currently contra-indicated. This is especially good news for symptomatic patients with known Crohn's disease, and, in particular, can make a significant difference for the pediatric patient. Given remains committed to providing physicians with patient-friendly tools that enable them to better diagnose GI disorders and improve the quality of life of their patients."

Given has been marketing a similar Patency System in Europe since November 2003. The Agile Patency System has also been cleared for marketing in Australia.

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 340,000 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 http://www.givenimaging.com.

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.

Contact Information