Healthcare Industry News:  Capsule Endoscopy 

Devices Gastroenterology

 News Release - October 21, 2008

New Multicenter Study Underscores Value of Using PillCam(R) SB in Children Younger Than 8

A Second Study Shows Its Role as an Early Diagnostic Tool for Adults With OGIB

VIENNA, AUSTRIA--(Healthcare Sales & Marketing Network)--Oct 21, 2008 -- Given Imaging Ltd. (GIVN ) today announced that data from two new, large studies further confirmed the value of PillCam SB Capsule Endoscopy among young children with a range of small intestinal disorders and in adults with overt obscure gastrointestinal bleeding (OGIB). The abstracts were presented during the 16th United European Gastroenterology Week (UEGW) 2008 conference taking place in Vienna, Austria from October 18 - 22.

Impact on Management of Children's Disease

Following evaluation with PillCam Capsule Endoscopy, investigators changed the treatment and management of the disease in 60 percent of children with small intestinal disorders. The capsule was most effective in those children with severe recurrent abdominal pain, Crohn's disease and GI hemorrhage. Even in those cases when a negative diagnosis was made for severe recurrent abdominal pain, the PillCam video capsule provided sufficient information to alter management in 85 percent (10/12) of children.

"These data suggest that the PillCam SB capsule may be particularly helpful in the management of young children with recurrent abdominal pain," said Annette Fritscher-Ravens, MD, Homerton University Hospital, London and lead investigator. "The capsule is particularly suited to children, where previously diagnostic tools required anesthesia, were uncomfortable, or had a significant radiation burden. In contrast, the capsule is child- and parent-friendly."

The 83-patient, multi-center study aimed to determine the effectiveness of Capsule Endoscopy in influencing disease management in children under eight years of age. The patients who were included in the study underwent upper and lower GI endoscopy, and physicians recommended a course of treatment prior to capsule evaluation. Suggested changes to disease management were documented following the capsule evaluation.

The PillCam SB video capsule, when used with the PillCam Platform, is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up. The PillCam SB video capsule and the PillCam Platform are not cleared for use in children under 10 years of age and should not be used outside of the context of approved clinical trials with such patients. The pediatric study was partially sponsored by Given Imaging.

Achieving Positive Diagnosis Among Adults with OGIB

In a separate,198-patient study led by Marien Simon, MD, European George Pompidou Hospital in Paris, researchers determined that Capsule Endoscopy should be performed early in the diagnostic work-up to detect overt OGIB sooner. PillCam SB was also shown to have good performance in terms of quality of imaging and diagnostic yield in patients with occult OGIB and suspicion of enteropathy.

"Understanding when to utilize PillCam Capsule Endoscopy in the diagnostic algorithm is key to ensuring the best CE results and treatment outcomes," said Dr. Simon. "Overt OGIB patients benefit most when capsule is utilized shortly after a bleeding episode."

The study aimed to determine predictive factors for achieving conclusive diagnosis using univariate and multivariate analyses. Patients in the study underwent Capsule Endoscopy for overt OGIB, occult OGIB or enteropathy. Key findings are listed below:

-- 94% of cases demonstrated good quality CE imaging
-- 91% of SB explorations were complete
-- 94% of cases showed positive findings in the small bowel
-- CE findings were helpful for the choice of further exploration in 59% of patients
-- The accuracy rate between CE result and final diagnosis was 80%

The multivariate analysis, which included age, gender, antiplatelet drugs and duration between last bleeding episode and CE, showed that for overt OGIB, only duration between bleeding and CE and was a significant predictive factor for positive diagnosis.

For More Information

The use of PillCam SB in IBD management will be highlighted in a breakfast symposium sponsored by Given Imaging on Tuesday, October 21, at the Austria Center Vienna, Hall F1, beginning at 7:00 a.m. Other topics will include, "Capsule Retention in High Risk Patient Groups," "Evaluation of Colon Capsule Endoscopy in the Visualization of the Colon," and "The Role of Colon Capsule Endoscopy in the Detection of Ulcerative Colitis."

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 markets a number of available capsules: the second-generation PillCam SB 2 video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the second-generation PillCam ESO 2 video capsule to visualize the esophagus; the Agile(TM) 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 and various country approvals, but is not cleared for marketing or available for commercial distribution in the USA. More than 750,000 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, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (ELRN ) (Tel Aviv:ELRN.TA ). For more information, visit

Forward-Looking Statements

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) our ability to develop and bring to market new products, (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 significant litigation, (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, 2007. 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.

Source: Given Imaging

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