SOURCE: Given Imaging

October 29, 2007 03:00 ET

Given Imaging Announces Clinical Data Presented During United European Gastroenterology Week

New Interim PillCam® COLON Data Presented From Largest Prospective Capsule Endoscopy Study

YOQNEAM, ISRAEL--(Marketwire - October 29, 2007) - Given Imaging Ltd. (NASDAQ: GIVN) today announced that clinical data on PillCam COLON and PillCam® SB will be presented during United European Gastroenterology Week (UEGW), Europe's largest gastroenterology conference, in Paris, France from October 27-31.

Stanislas Chaussade, M.D., Head of Gastroenterology at the Hôpital Cochin in Paris said, "The capsule endoscopy data presented this week at UEGW shows how important this procedure has become to the field of gastroenterology. New indications for PillCam SB continue to emerge validating its long-term benefits for patients with unexplained small intestinal disorders. While still a relatively new video capsule, PillCam COLON continues to show great promise, especially in the area of colorectal cancer screening where in Europe less than 10% of patients are compliant."

Data highlights included:

PillCam COLON

Jacques Devière, M.D., Chairman of the Department of Gastroenterology and Hepatology at Erasme University Hospital, Brussels, Belgium, and president of the European Society of Gastrointestinal Endoscopy presented interim results from a prospective study on PillCam COLON involving eight centers from six European countries. The aim of the study is to assess PillCam COLON's yield in detecting polyps, cancers and other pathologies in the colon compared to traditional colonoscopy in 329 patients. This is the largest prospective capsule endoscopy study conducted to date.

Interim findings from 166 patients with a mean age of 60, with known or suspected colonic disease were presented. Each patient did a colon prep and ingested the PillCam COLON video capsule in the morning. Once the capsule was excreted, patients also underwent colonoscopy. Independent physicians performed the exams and were blinded to each others' results. Significant findings were defined as at least one polyp measuring 6 mm or three or more polyps of any size.

The capsule completed the examination and was excreted from the body within 10 hours post ingestion in 96% of the patients. No severe adverse events were related to the capsule. Colonoscopy detected significant findings in 46% (n=75) of patients. The sensitivity/specificity for PillCam COLON to detect significant findings was 72%/80%. The investigators concluded that PillCam COLON could eventually be used for polyp detection and increase compliance for CRC screening.

PillCam SB

Small Bowel Tumors

A retrospective study led by Erik Peter Skogestad, M.D. at Innlandet Hospital Trust Lillehammer in Norway assessed the prevalence of small bowel tumors found by capsule endoscopy in obscure bleeding patients. Of the 195-patient cases studied, capsule endoscopy detected small bowel tumors in 5.6% of patients (n=11). However, when the indication was obscure GI bleeding (n=73), the tumor detection rate increased to 12.3% (n=9). The investigators concluded that one in eight capsule endoscopy procedures performed found a small bowel tumor when the indication was obscure GI bleeding, a higher incidence rate then previously reported.

Iron Deficiency Anemia

Led by Michel Delvaux, M.D. Professor, Hôpitaux de Brabois in France, this retrospective study compared the clinical characteristics in chronic iron-deficiency anemia (CIDA) and obscure GI bleeding patients and evaluated the diagnostic yield of capsule endoscopy in patients specifically with CIDA. Two groups of patients were selected from a database of 604 patient case studies conducted between 2002 and 2006. Group I consisted of 93 CIDA patients and Group II consisted of 233 patients with obscure GI bleeding.

The overall diagnostic yield of capsule endoscopy in Group I was 68.8% compared to 78.5% for Group II. Active bleeding was found in 3% of patients in Group I vs. 10% in Group II and intestinal tumors in 4 patients in Group I vs. 19 in Group II.

The study concluded that capsule endoscopy has a high diagnostic yield in CIDA patients but a lower yield when compared to patients with obscure GI bleeding. It was recommended that capsule endoscopy be performed early in the diagnostic work-up of patients with CIDA to help physicians determine the next course of action.

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 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 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 and is pending clearance with the United States Food and Drug Administration. More than 600,000 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. 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) the reimbursement policies for our product from healthcare 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.

Contact Information

  • For further information contact:

    Matthias Stief
    Given Imaging Ltd.
    +49 (162) 211 6613

    or

    Fern Lazar/David Carey
    Lazar Partners Ltd.
    1-212-867-2355
    Email Contact/
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