PillCam(R) SB Visualizes Disease Severity, Guides Treatment And Provides Better Sensitivity For The Detection Of Villus Atrophy

Main Category: GastroIntestinal / Gastroenterology
Article Date: 04 Mar 2008 - 1:00 PDT

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Given Imaging Ltd. (NASDAQ: GIVN) announced that a study by researchers at the Mayo Clinic reported that capsule endoscopy is a more effective tool to diagnose celiac disease and detect damage throughout the small intestine than upper endoscopy. Researchers also found that celiac affects a highly variable portion of the small intestine and that the severity of symptoms did not correlate to the severity of intestinal damage.

The Mayo study utilizing Given Imaging's PillCam SB was led by Mayo Clinic gastroenterologist Joseph Murray, M.D. and appears in this month's issue of Clinical Gastroenterology and Hepatology.

"We're pleased that this study confirms that PillCam SB, which has the advantage of visualizing the entire small bowel, can help clinicians diagnose and monitor the severity of celiac disease regardless of their patient's symptoms," said Homi Shamir, CEO of Given Imaging.

According to the Mayo Clinic, this study, which is the first of its kind, used capsule endoscopy to view intestinal damage in 38 patients with untreated, biopsy-proven celiac disease. Indications for clinical evaluation were malabsorption syndrome and iron deficiency anemia. Ninety-two percent had visible damage detected by capsule endoscopy while upper endoscopy only detected visible damage in 55% of the patients. Neither capsule endoscopy nor upper GI series yielded false positives.

This study also indicated that a high proportion of adults may not heal their intestinal abnormalities even after a year or more on a gluten-free diet. Biopsy specimens of the proximal small bowel alone may not reflect the healing that has occurred distally in response to a gluten-free diet. Capsule endoscopy showed that healing in the small intestine occurred from the distal to the proximal direction with most residual changes remaining in the duodenum. Capsule endoscopy may play a role in monitoring the healing process of a patient on a gluten-free diet.

Given Imaging's PillCam SB video capsule was the first capsule endoscope on the market designed specifically to help doctors see inside all 30-feet of the small bowel (small intestine) to diagnose disorders such as Crohn's disease, Celiac disease, benign and cancerous tumors, ulcerative colitis as well as others disorders.

The smooth plastic capsule contains a miniature video camera and is equipped with a light source on one end, batteries, a radio transmitter and antenna. After it is swallowed, the PillCam SB capsule transmits approximately 50,000 images over the course of an 8-hour period (about 2 images per second) to a data recording device attached to a belt worn around the patient's waist. The small bowel images are then downloaded into a Given® Workstation computer where a physician can review the images in order to make a diagnosis.

About Celiac Disease

Celiac disease interferes with absorption of nutrients and is an autoimmune disorder of the small intestine. In celiac, gluten, found in all forms of wheat and some related grains, creates a reaction that damages the mucosal surface of the small intestine. Symptoms can include recurrent bloating, gas or abdominal pain; chronic diarrhea or constipation; unexplained anemia; fatigue, weakness or lack of energy; and others. Without treatment, damage to the small bowel can be chronic and life-threatening. One in 133 people is affected by celiac disease.(1)

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 a number of 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 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 650,000 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 operating subsidiary companies in the United States, Germany, France, Japan and Australia. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). For more information, visit http://www.givenimaging.com.

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) our ability to receive regulatory clearance or approval to market our products or 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) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) 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, 2006. 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.

(1) Celiac Disease Foundation

Given Imaging Ltd.