SOURCE: Given Imaging

Given Imaging

May 09, 2011 17:45 ET

Given Imaging Announces New Studies Confirm PillCam® SB's Role in the Management of Patients With Suspected and Known Crohn's Disease

Data Show That Using PillCam SB Allows Doctors to Improve Care for Patients With Crohn's Disease

CHICAGO, IL--(Marketwire - May 9, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the results of new studies confirming the value of using PillCam SB to detect lesions indicative of Crohn's disease, as well as to monitor disease progression in patients with suspected and known Crohn's disease. The studies were presented at Digestive Disease Week (DDW) 2011, taking place May 7th - 10th at the McCormick Place Convention Center. Given Imaging is exhibiting at booth #2143 at the conference.

"Capsule endoscopy has long been the standard for detecting obscure gastrointestinal bleeding of the small bowel. Recently, several new clinical studies have highlighted the value of PillCam SB for visualizing lesions in patients with suspected or known Crohn's disease," said Stanley Cohen, MD, of the Children's Center for Digestive Healthcare in Atlanta, Georgia. "We have also learned that there is significant value in using PillCam SB to monitor the progression of Crohn's disease and to determine if patients are responding to therapy or if a change in treatment is required. We are obtaining new information from the PillCam SB procedure that we can utilize to ensure we are providing optimal ongoing treatment for each patient with Crohn's disease."

Three poster presentations determined that new data acquired during capsule endoscopy procedures in patients with suspected and known Crohn's disease led to changes in how physicians treated patients:

  • Jonathan Leighton, MD, Division of Gastroenterology, Mayo Clinic, Scottsdale, AZ, presented results of a study, abstract Sa1051, which showed that using capsule endoscopy, prior to colonoscopy and SBFT, impacts disease management. The prospective multicenter blinded cohort study of 74 patients with suspected small bowel Crohn's disease found that capsule endoscopy altered disease management in 32% of patients, as compared to 23% and 14% for colonoscopy and SBFT, respectively. Of the 32% of patients whose disease management was altered due to capsule endoscopy findings, 88% changed medication.

  • Erika Boroff, MD, Instructor in Medicine, Department of Community Internal Medicine, Mayo Clinic, Scottsdale, presented a retrospective review on the change in disease management as a result of capsule endoscopy findings in 114 patients with suspected and established Crohn's disease, in abstractMo1525. Capsule endoscopy resulted in a surgical or medical disease management change in 27 of 114 or 38.7% of patients.

  • A third retrospective study of 732 pediatric patients, abstract Mo1560, concluded that capsule endoscopy can improve the diagnosis and evaluation of the extent and severity of Crohn's disease in pediatric patients. Stanley Cohen, MD, Children's Center for Digestive Healthcare of Atlanta, Children's Healthcare of Atlanta, and colleagues also found that PillCam SB was effective in assisting physicians in guiding patient management in the pediatric population.

In his podium presentation of abstract#852, Rami Eliakim, MD, Chair of Medicine and Director of the Department of Gastroenterology at Rambam Health Care Campus, Haifa, Israel, presented key findings from a prospective multicenter study of 80 patients, underscoring that PillCam SB was superior to small bowel follow through (SBFT), a radiological exam of the small bowel, to visualize suspected lesions indicative of Crohn's disease. Furthermore, capsule endoscopy achieved the same diagnostic yield as colonoscopy, the standard for diagnosing small bowel Crohn's disease. The study also determined that the combination of capsule endoscopy with colonoscopy had a significantly higher diagnostic yield (97.3%) for detecting lesions compared to small bowel follow through with colonoscopy (57.3%). The researchers concluded that capsule endoscopy appears to be a better diagnostic tool than SBFT for suspected Crohn's disease.

About Crohn's Disease
Crohn's disease is a chronic condition that causes inflammation in the lining of the small intestine wall and can affect any part of the digestive tract. Symptoms can include diarrhea, abdominal pain, weight loss and rectal bleeding. Roughly 50% of all cases of Crohn's disease are diagnosed in the last part of the small intestine (the terminal ileum) and cecum. This area is also known as the ileocecal region. Other cases of Crohn's may affect one or more of the following: the colon only, the small bowel only (duodenum, jejunum and/or ileum), the stomach or esophagus1. Roughly 500,000 Americans suffer from Crohn's disease, and about 20% have a direct relative with some form of inflammatory bowel disease (IBD)2. Crohn's disease affects men and women equally. The cause is unknown; but, the most popular theory is that the immune system is reacting to a virus or bacterium that causes inflammation3. Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease4.

About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

About PillCam SB
The PillCam® SB video capsule measures 11 mm x 26 mm and weighs less than four grams. Now in its second generation, PillCam SB 2 contains an imaging device and light source and transmits images at a rate of two images per second, generating more than 50,000 pictures during the course of the procedure. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is clinically validated by more than 1,500 peer-reviewed studies. It is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB is the gold standard in small bowel evaluation.

All medical procedures carry some risks. The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the Agile GI patency test include capsule retention and aspiration. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

About Given Imaging Ltd.
Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® video capsules for the small bowel, esophagus and colon [PillCam® COLON not approved for use in the United States], industry-leading ManoScan™ high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and to supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam and Hong Kong. For more information, please visit www.givenimaging.com.

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 successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) lack of an appropriate bowel preparation materials to be used with our PillCam COLON capsule, (8) protection and validity of patents and other intellectual property rights, (9) the impact of currency exchange rates, (10) the effect of competition by other companies, (11) the outcome of significant litigation, (12) our ability to obtain reimbursement for our product from government and commercial payors, (13) quarterly variations in operating results, (14) the possibility of armed conflict or civil or military unrest in Israel, (15) the impact of global economic conditions, (16) our ability to successfully integrate acquired businesses, (17) changes and reforms in applicable healthcare laws and regulations, (18) adverse events related to our products or product quality issues that could require us to recall products and impact our sales, and (19) 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, 2010. 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) http://www.ccfa.org/info/about/crohns Inflammatory Bowel Disease Frequently Asked Questions.

(2) Crohn's and Colitis Foundation of America (ccfa.org)

(3) National Institute of Diabetes and Digestive and Kidney Diseases (niddk.nih.gov)

(4) http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html

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