SOURCE: Given Imaging

February 12, 2007 08:30 ET

Given Imaging Announces United Healthcare Expands Policy to Cover Celiac Disease

Trailblazer Health Enterprises Also Issues New Policy Covering Both PillCam SB as Well as PillCam ESO for Patients With Portal Hypertension

YOQNEAM, ISRAEL -- (MARKET WIRE) -- February 12, 2007 -- Given Imaging Ltd. (NASDAQ: GIVN) today announced one revised and one new capsule endoscopy reimbursement policy.

United Healthcare revised its small bowel capsule endoscopy coverage policy to include suspected celiac disease patients with a positive serology, but a normal endoscopic biopsy, and patients with known celiac disease and suspected malignancy. United Healthcare serves more than 18 million customers.

"Celiac disease is a serious life-long intestinal disorder that affects one out of every 133 Americans, most of whom have no idea that they have the disease. Broader use of PillCam SB can enhance our ability to diagnose and monitor more patients with celiac," said Peter H.R. Green, MD, Director of The Celiac Disease Center at Columbia University.

TrailBlazer Health Enterprises, a Part B Medicare carrier serving more than 3.6 million individuals in Delaware, the District of Columbia, Maryland, Texas and Virginia, issued a new policy covering capsule endoscopy of both the small bowel, as well as the esophagus. TrailBlazer's small bowel policy covers a variety of indications including celiac and Crohn's disease. The TrailBlazer policy also states that esophageal capsule endoscopy may be used to evaluate esophageal varices in patients with portal hypertension as an alternative to upper GI endoscopy. Portal hypertension is a major complication of liver cirrhosis and can lead to variceal bleeding or death if not treated.

"Clinical studies have shown PillCam ESO is an accurate, noninvasive alternative to upper endoscopy to detect esophageal varices without the need for conscious sedation," said Dr. John M. Vierling M.D., Professor of Medicine and Surgery, Director of Baylor Liver Health and Chief of Hepatology at the Baylor College of Medicine in Houston, Texas and past president of American Association for the Study of Liver Diseases (AASLD).

The payors that cover PillCam ESO for this designation serve more than 6.6 million members in the U.S.

About Given Imaging Ltd.

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam™ Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 50 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. More than 400,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. 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 within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam Colon, (2) changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the impact of the newly adopted SFAS 123R for expensing option-based payments, (11) the possibility of armed conflict or civil or military unrest in Israel, and (12) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

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