SOURCE: Given Imaging

Given Imaging

October 18, 2010 10:42 ET

UPDATE: Data Presented at the ACG Annual Meeting Find Significant Role for PillCam® SB in Inflammatory Bowel Disease Management

SAN ANTONIO, TX--(Marketwire - October 18, 2010) - Given Imaging Ltd. (NASDAQ: GIVN) today announced new data highlighting the clinical value of PillCam SB capsule endoscopy in disease management. The new data were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in San Antonio, TX from October 15 through October 20, 2010. Given Imaging is exhibiting at booth #715 at the meeting. 

"The body of research on capsule endoscopy continues to grow, supporting its utility in helping clinicians accurately care for patients with conditions of the small bowel, such as inflammatory bowel disease (IBD)," said Dr. Hans Herfarth, University of North Carolina at Chapel Hill. "We also are encouraged to see research that adds to clinician knowledge about achieving optimal patient outcomes using this important technology."

Abstracts presented included the following:

  • Poster presentation, P282, led by Dr. Millie Long and Dr. Hans Herfarth, of the University of North Carolina at Chapel Hill, concluded capsule endoscopy impacts the overall management of inflammatory bowel disease. The study authors conducted a retrospective study of 128 capsule endoscopy procedures performed at University of North Carolina Hospitals from 2003-2009 to determine whether capsule endoscopy led to changes in the clinical management of patients with established IBD (Crohn's disease, indeterminate colitis and pouchitis). The researchers found patients with known Crohn's disease were most likely to have positive capsule endoscopy findings, followed by patients with pouchitis and indeterminate colitis. The findings from the capsule endoscopy procedure resulted in management changes in the majority of cases, regardless of the specific capsule endoscopy findings or the subtype of inflammatory bowel disease. 
  • Led by Dr. Surinder Mann, University of California, Davis in Sacramento, CA, abstract #P536 won the 2010 Presidential Poster Award for research on the effects of chronic anti-coagulants on video capsule endoscopy results. The retrospective review of 250 patients undergoing capsule endoscopy for obscure gastrointestinal bleeding (OGIB) showed a significantly higher diagnostic yield for VCE procedures performed in patients on chronic anti-coagulation medications. The study's authors concluded that earlier use of capsule endoscopy in this patient population is warranted and suggest that patients continue taking their anti-coagulant medication until just prior to the exam, when applicable.
  • In poster presentation, P541, led by Dr. Rome Jutabha, University of California, Los Angeles, researchers retrospectively reviewed 882 small bowel capsule endoscopy cases from a single center. The most common capsule endoscopy findings were angiodysplasia (56.8%), ulcers (32.5%), lymphangiectasia (26%) and mass lesions (20.9%). The researchers concluded capsule endoscopy is a safe and effective diagnostic tool for detecting small bowel pathology, including obscure gastrointestinal bleeding, suspected Crohn's disease and small bowel tumors.

About Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD) refers to conditions which cause chronic inflammation of the gastrointestinal tract, specifically ulcerative colitis and Crohn's Disease. In the United States, more than 1 million people suffer from IBD, with new cases diagnosed at a rate of 10 cases per 100,000 people(1). Typically symptoms of IBD include diarrhea, rectal bleeding, urgency to have bowel movements, abdominal cramps and pain, fever, and weight loss. The primary difference between ulcerative colitis and Crohn's disease are the affected areas of the gastrointestinal tract. Ulcerative colitis occurs only in the large intestine and is limited to the inner lining of the intestinal wall, where as Crohn's disease can involve any area of the gastrointestinal tract(2). 

About Obscure GI Bleeding
Occult gastrointestinal bleeding (OGIB) occurs when blood is lost from the digestive tract without visible, or overt, signs of bleeding(3). The condition is usually discovered only with positive results for a fecal occult blood test or through detection of iron deficiency anemia, and there are many potential causes. In approximately half of patients with OGIB, the source of bleeding is unexplained(4).

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 1,200 peer-reviewed studies. It is the most accurate, patient-friendly tool for visualization of the small bowel in patients two years and older and is used by physicians to evaluate patients with obscure GI bleeding, including iron deficiency anemia, suspected Crohn's disease, suspected small intestinal tumors, monitoring patients with polyposis syndromes and in suspected or refractory malabsorptive syndromes, such as celiac disease. PillCam® SB is the gold standard in small bowel evaluation.

About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal visualization by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam® capsule endoscopy uses cutting-edge, wireless technology and advanced software to provide physicians with natural images of the small intestine via PillCam® SB, the esophagus through PillCam® ESO and the colon with PillCam® COLON [PillCam® COLON is not cleared for use in the USA]. The PillCam® capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). In April, 2010, Given Imaging acquired Sierra Scientific Instruments, the leading provider of specialty GI diagnostic solutions and pioneer of high-resolution manometry for assessing gastrointestinal motility. Sierra Scientific is now a wholly-owned subsidiary of Given Imaging.  Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia 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 and (18) 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, 2009. 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.acg.gi.org/patients/gihealth/ibd.asp
(2) http://www.mayoclinic.com/health/crohns-disease/DS00104
(3) http://www3.utsouthwestern.edu/endocrine/Rockey.htm
(4) http://www.aafp.org/afp/20040215/875.html

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