Given Imaging Announces Extensive Data From More Than 140 Abstracts to Be Presented at Digestive Disease Week(R) 2013

Company Will Highlight Numerous Milestones Including a Celebration of More Than Two Million Uses of PillCam(R) Capsules in Patients Worldwide


YOQNEAM, Israel, May 13, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that numerous studies confirming the value of Given Imaging's portfolio of GI diagnostic and monitoring products will be presented at the upcoming Digestive Disease Week (DDW). DDW will take place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. Given Imaging will be exhibiting at booth #1059 throughout the conference.

"DDW is an opportunity to showcase the clinical utility of our entire product portfolio in diverse disease state areas including Crohn's disease, GERD, GI dysmotility, OGIB, colorectal cancer and achalasia," said Homi Shamir, President and Chief Executive Officer, Given Imaging. "In conjunction with DDW, we are also excited to celebrate that more than two million PillCam capsules have been used in patients around the world. This important milestone showcases the tremendous influence this product has for detecting and monitoring conditions of the GI tract."

More than 140 studies presented at DDW will feature data on Given Imaging's leading GI diagnostic product portfolio including PillCam® SB, PillCam® COLON 2*, PillCam® ESO, Bravo® pH monitoring, Digitrapper® pH-z monitoring, ManoScan® high resolution manometry and the SmartPill® motility monitoring system.  All data presented at DDW will be embargoed until the time of presentation. Important poster and podium presentations include:

  • Poster presentation Sa1323, Is the Chicago Classification for Esophageal Motility Disorders Useful to Predict Symptom Severity?, on Saturday, May 18th from 8:00 am - 5:00 pm
  • Poster presentation Sa2034, Development of New Parameters to Evaluate Anorectal Function Using High-Definition Anorectal Manometry (HDM). the Anal Contractile Integrated (Aci), the Post Squeeze Pressure (Psp), the Anal Integrated Relaxation Pressure (Airp), and the Sliding Velocity in the Anal Canal (Svac), on Saturday, May 18th from 8:00 am - 5:00 pm
  • Podium presentation 689, Evaluation of the Second Generation Colon Capsule Endoscopy (Cce-2) in Pediatric Ulcerative Colitis (UC), on Monday, May 20th at 10:00 am
  • Podium presentation 703, Prospective Trial of PillCam Colon Capsule (CCE) vs CT-Colonography (CTC) in the Evaluation of Patients With Incomplete Conventional Colonoscopy (CC): an Interim Analysis, on Monday, May 20th at 10:30 am
  • Poster presentation Mo2092, Wireless Motility Capsule Alters Diagnosis and Affects Clinical Management in Patients With Suspected Gastrointestinal Dysmotility, on Monday, May 20th from 8:00 am – 5:00 pm
  • Podium presentation 907, Accuracy of PillCam COLON 2 for Detecting Subjects With Adenomas Greater Than or Equal To 6 mm, on Tuesday, May 21st at 8:45 am
  • Poster presentation Tu1301, 8-Hour CE Versus 12-Hour CE in a Cohort of Hospitalized Patients Undergoing CE for Suspected Small Bowel Disorders, on Tuesday, May 21st from 8:00 am – 5:00 pm
  • Poster presentation Tu1781, Description of Findings in Esophageal Impedance -pH Monitoring in Patients With Extraesophageal Symtomps and Suspected GERD in Hospital San Ignacio Bogota A Hani, L Galindo, R Cañadas, R Rincón, A Rodríguez, R Vargas, Y Suarez, G Guzmán, M Herrán, M Hernández, A Leguizamo, J Alvarado, on Tuesday, May 21st from 8:00 am – 5:00 pm

Given Imaging will be exhibiting at booth #1059 throughout DDW and will have information available about the Company's entire product portfolio, including the latest information on product and software advancements. At the booth, the Company will also be highlighting the milestone of more than two million uses of PillCam capsules in patients worldwide. Given Imaging representatives will also demonstrate the new Bravo pH monitoring recorder.

*PillCam® COLON has received a CE Mark, but is pending 510K FDA clearance and is not cleared for marketing or available for commercial distribution in the U.S.A., Japan and certain other countries.

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. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

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 endoscopes 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, 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, 2012. 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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