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Given Imaging Announces New Studies Further Validating PillCam(R) SB as the Gold Standard for Identifying and Evaluating Small Bowel Abnormalities

Tue, 10/23/2012 - 4:15pm
The Associated Press

Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced new studies underscoring the value of PillCam® SB in identifying and evaluating small bowel abnormalities. The studies are being presented at the American College of Gastroenterology 2012 annual meeting taking place in Las Vegas from October 19-24, 2012. Given Imaging is exhibiting at booth #1325 throughout the conference.

In poster presentation P728, "Small Bowel Tumors Identified by Deep Enteroscopy: A Single Center Experience," by Kartikkumar Jinjuvadia, MD, Indiana University School of Medicine, Indianapolis, IN, and colleagues, the researchers aimed to report on the prevalence, clinical features and diagnosis of small bowel mass lesions (SBML). Patients with SBML were identified from a prospectively collected single-center deep enteroscopy database at a large tertiary care center. Three hundred forty-seven patients underwent 457 deep enteroscopies from March 2006 to November 2011. Investigators compared a range of variables including patient demographics, presentation, tumor type and location between two different patient groups -- one with small bowel mass lesions and a control group without tumors. Investigators also looked at the diagnostic yield of capsule endoscopy as compared to radiological imaging in identifying tumors. In addition to showing that patients with tumors tended to be male and more likely to present with occult bleeding, the results also underscored that capsule endoscopy was positive in identifying SBML in 95% of cases studied, whereas radiological imaging was positive in only 56% of cases studied.

In poster presentation P1591, "Application of the SPICE Criteria to Previously Seen Low Risk Bulges: Results from the University of California Irvine Capsule Endoscopy Database," by William Nguyen, MD, University of California-Irvine, Irvine, CA, the researcher validated the use of capsule endoscopy in categorizing low-risk luminal bulges, the most common unexplained finding during capsule endoscopy that may sometimes be mistaken for submucosal malignant masses. The retrospective study reviewed all available capsule endoscopy studies from 2002-2009 from the University of California-Irvine capsule database. Of the 604 reports reviewed, bulges were identified in 25% of capsule studies with 91.3% of those bulges being previously categorized by capsule endoscopy as low risk bulges. Dr. Nguyen applied the recently published Smooth, Protruding lesion Index on Capsule Endoscopy (SPICE) criteria, which was developed to help differentiate which low risk bulges need further investigation, to the studies in which capsule endoscopy had previously identified low risk bulges. Dr. Nguyen found that each study was rated as having a SPICE score of less than 3 indicating that capsule endoscopy had correctly differentiated low risk bulges in all of the studies.

"The body of clinical data continues to underscore the benefit of using PillCam SB to identify and evaluate small bowel abnormalities," said Dr. David Mason, Senior Vice President and Chief Medical Officer, Given Imaging. "In addition to its diagnostic value, capsule endoscopy is also generally preferred by patients as it is safer and less invasive than other diagnostic modalities."

About ACGThe American College of Gastroenterology is a recognized leader in educating GI professionals and the general public about digestive disorders. Their mission is to serve the evolving needs of physicians in the delivery of high quality scientific, humanistic and cost-effective health care to gastroenterology patients. For more information, visit http://gi.org.

About PillCam® SB The PillCam® SB video capsule is a minimally invasive procedure to visualize and monitor lesions associated with inflammatory bowel disease (IBD), Crohn's disease and obscure GI bleeding (OGIB). The PillCam 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 1,600 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. The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the PillCam patency capsule 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® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan™ high-resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z impedance, and the SmartPill® GI monitoring systems. Given Imaging is committed to delivering breakthrough innovations to the GI community and 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, Hong Kong and Brazil. 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. Such forward-looking statements include statements relating to the Company exploring strategic alternatives and considering possible strategic transactions involving the Company. 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 ability of the Company to reach agreement on any strategic alternative and/or to complete any such alternative, as well as 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) quality issues and adverse events related to our products, such as capsule retention, aspiration and failure to attach or detach, bleeding or perforation that could require us to recall products and impact our sales and net income, 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, 2011. 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 to the extent expressly required under applicable law, the Company undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

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