Given Imaging Ltd announced two studies concluding that PillCam SB capsule endoscopy is a modality of choice in diagnosing the cause of unexplained iron deficiency anemia (IDA) following negative endoscopy and can lead to a definitive diagnosis in this group. The studies were presented this week at The 13th World Congress of Gastroenterology (WCOG), taking place in Montreal, September 10th -14th.

The National Institutes of Health (NIH) estimates that 20% of women and 3% of men in the United States have IDA. Iron is an essential component of hemoglobin, the oxygen-carrying pigment in the blood. The causes of iron deficiency are too little iron in the diet, poor absorption of iron by the body, and loss of blood (including from heavy menstrual bleeding). According to the NIH, in men and postmenopausal women the cause of IDA is usually GI bleeding associated with ulcers, use of non-steroidal anti-inflammatory drugs (NSAIDs) or cancer. Published literature shows that patients may undergo up to seven procedures before a definitive diagnosis is made.

A 253 patient prospective study led by Periklis Apostolopoulos, M.D., from Athens, Greece, sought to investigate the value of PillCam SB in detecting small bowel lesions likely to cause anemia. Patients included had unexplained IDA and had undergone negative gastroduodenoscopy (upper endoscopy) plus biopsies and ileocolonoscopy (colonoscopy) procedures. PillCam SB detected a likely cause of the symptoms in 57% of these patients. "While traditional diagnostic methods for IDA are effective, the cause of IDA remains undetected up to 30% of the time. The data from our study concludes that using PillCam SB can lead to definitive diagnoses of the underlying causes of unexplained IDA in this group of patients," said Dr. Apostolopoulos.

Between December 2003 and December 2004, 253 patients with a median age of 57 years were referred for unexplained IDA and received an upper endoscopy with biopsy and a lower endoscopy. Endoscopic/histological tests in 51 of these patients (20.1%) were negative and PillCam SB was subsequently performed. This patient group was also rigorously screened to exclude other possible causes of blood loss. The PillCam SB found one or more small bowel lesions likely to cause IDA in 29 patients (57%). To confirm the PillCam SB findings, investigators performed air double-contrast enteroclysis (EC) following PillCam SB and found abnormal findings in only 6 of 51 patients (11.7%) of patients.

A second, unrelated study led by Waseem Ashraf, M.D. and colleagues at King George Hospital in London mirrored these results. Designed to assess the diagnostic yield of PillCam SB in patients referred for unexplained IDA and other GI conditions, in 48 patients who completed the study, the cause of IDA symptoms was identified in 27 (56.0%). Positive findings in patients with unexplained IDA included Crohn's disease (6), tumors/polyps (4), of which 2 were confirmed to be malignant, angiodysplasia (4), NSAID-related ulcers (2) and intestinal worms.

The investigators confirmed previously-reported findings that PillCam SB detects and visualizes small bowel problems not detected in patients with IDA and suspected occult GI blood loss that had undergone extensive diagnostic investigation. The findings also showed a high incidence of Crohn's disease and small bowel tumors in these patients.

Dr. Ashraf and his research team concluded that PillCam SB should be the diagnostic modality of choice following a normal upper GI endoscopy and colonoscopy in patients with unexplained IDA and occult gastrointestinal bleeding.

About the World Congress

The World Congress is organized by OMGE (Organization Mondiale de Gastro-Enterologie) in collaboration with OMED (Organization Mondiale d'Endoscopie Digestive) and other interest organizations at time intervals to be determined by the Governing Council of OMGE according to the statues, generally every four years.

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(TM) video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the Given(R) Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB capsule is the only 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 230,000 patients worldwide. The PillCam(TM) 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.

Given Imaging Ltd.
http://www.givenimaging.com