SOURCE: Given Imaging

Given Imaging

May 18, 2012 16:01 ET

Given Imaging Announces Strong Presence at Upcoming Digestive Disease Week® 2012

More Than 100 Studies on PillCam® Capsule Endoscopy and Given Imaging Reflux and Manometry Products Presented

YOQNEAM, ISRAEL--(Marketwire - May 18, 2012) - Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that a wide range of new studies will be presented at Digestive Disease Week® (DDW)® that confirm the value of its PillCam® SB, reflux and manometry products including Bravo, Digitrapper and Manoscan, and PillCam® COLON 2 in detecting and monitoring gastrointestinal diseases. Studies on the topics of pediatric Crohn's disease, upper gastrointestinal care, and new uses of PillCam SB will be presented, as well as studies on PillCam COLON 2. Given Imaging will be exhibiting at booth #2015 during DDW, taking place in San Diego from May 19-22, 2012.

"Given Imaging is proud of its role as a leader in developing innovative products for GI diagnostics," said Homi Shamir, president and CEO, Given Imaging. "Since 2001, when Given Imaging introduced capsule endoscopy to gastroenterologists, more than one and a half million PillCam capsules have been ingested by patients to help doctors improve the detection and monitoring of GI diseases. We thank the physicians and nurses who continue to advance clinical knowledge about diseases of the GI tract and to improve patient care."

Key studies to be presented at the meeting include:

Pediatric Crohn's Disease:

(Embargoed until May 19, 2012, 8 am PT)
Video Capsule Endoscopy Improves Clinical and Growth Outcomes in Pediatric IBD Patients (Sa1995)
Poster Presentation/Investigators: Steve B. Min, Minou Le-Carlson, Jennifer Gebbia, Kelly Haas, Shervin Rabizadeh, Neel K. Mann, Simon K. Lo, Gil Y. Melmed, Marla Dubinsky
Time: 8 am to 5 pm

(Embargoed until May 19, 2012, 8 am PT)
Mucosal Healing With the Specific Carbohydrate Diet in Pediatric Crohn's Disease: Preliminary Results of a Prospective Pilot Study (Sa1992)
Poster Presentation/Investigators: Stanley A. Cohen, Angela N. Stallworth, Bailey M. Koch, David H. Mason, Jeffrey Blumenthal, Benjamin D. Gold
Time: 8 am to 5 pm

New Uses of PillCam SB:

(Embargoed until May 19, 2012, 11:30 am PT)
The Twelve-Hour Battery Given Wireless PillCam SB2ex Improves Overall Cecal Intubation Rate and Increases the Positive Yield (153)
Topic Forum/Investigators: Neel K. Mann, Navin Paul, Simon K. Lo
Time: 11:30 am

(Embargoed until May 19, 2012, 2:30 PT)
Improved Diagnostic Yield with Early Video Capsule Endoscopy After Diagnosis of Obscure Gastrointestinal Bleeding (216)
Research Forum/Investigators: Dhavan A. Parikh, Mohit Mittal, Surinder K. Mann, Preethika S. Ekanayake
Time: 2:30 pm

(Embargoed until May 19, 2012, 8 am PT)
Capsule Endoscopy in Octogenarians: Analysis of a Large Prospectively Collected Database (Sa1742)
Poster Presentation/Investigators: Victoria Gomez, Mihir K. Patel, Mark E. Stark, Frank Lukens
Time: 8 am to 5 pm

(Embargoed until May 19, 2012, 8 am PT)
Improved Visualization of Small Bowel Lesions by Capsule Endoscopy Using Flexible Spectral Imaging Color Enhancement (FICE) System (Sa1592)
Poster Presentation/Investigators: Yasushi Sato, Masahiro Hirakawa, Hiroyuki Ohnuma, Kohichi Takada, Tsutomu Sato, Koji Miyanishi, Rishu Takimoto, Masayoshi Kobune, Junji Kato
Time: 8 am to 5 pm

PillCam COLON 2:

(Embargoed until May 19, 2012, 3:15 pm PT)
Capsule Colonoscopy with PillCam Colon 2 Is Feasible as an Out-Of-Clinic Procedure: (219)
Research forum/Investigators: Samuel N. Adler, Yishai Sompolinsky, Yoav C. Metzger, Cesare Hassan
Time: 3:15 pm

(Embargoed until May 21, 2012, 8 am PT)
PillCam Colon (C2) vs. Colonoscopy in the Assessment of Colon Mucosa in Patients with Ulcerative Colitis (Preliminary Data) (Mo1390)
Poster Presentation/Investigators: Mileidis E. San Juan-Acosta, Alba Belda-Cuesta, Angel Caunedo-Alvarez, Javier Romero-Vazquez, Blas J. Gomez-Rodriguez, Maria L. Morales, Federico Arguelles-Arias, Juan M Herrerias
Time: 8 am to 5 pm

Manometry:

(Embargoed until May 19, 8 am PT)
The High Resolution Manometric Profile of PPI Non-Responders (Sa1352)
Poster Presentation/Investigators: Yinglian Xiao, Joan Chen, Annemijn de Ruigh, Frédéric Nicodème, Mary Kwasny, Chang Lu, Lubomyr Boris, Gabriela I. Escobar, Peter J. Kahrilas, John E. Pandolfino
Time: 8 am to 5 pm

(Embargoed until May 22, 2012, 8 am PT)
How Accurate Is Computerized Analysis Versus an Expert Analysis for Evaluating Anorectal Function Using 3-D High Definition Anorectal Manometry (Tu1415)
Poster Presentation/Investigators: Enrique Coss-Adame, Jessica Valestin, Satish S. Rao
Time: 8 am to 5 pm

Additional Products:

(Embargoed until May 19, 8 am PT)
Slow Esophageal Propagation Velocity: a Finding in Patients With Dysphagia for Solids (Sa1196)
Poster Presentation/Investigators: Abhinav Sankineni, Lucy Salieb, Martha J. Harrison, Robert S. Fisher, Henry P. Parkman
Time: 8 am to 5 pm

(Embargoed until May 19, 8 am PT)
Impact of Esophageal Motor Disorders on Bolus Transit As Measured by Radionuclide Esophageal Transit Scintigraphy (Sa1199)
Poster Presentation/Investigators: Junichi Akiyama, Pankaj J. Pasricha, Linda Anh B. Nguyen
Time: 8 am to 5 pm

(Embargoed until May 19, 10:30 am PT)
Inter-Observer Agreement for Manometry Classification of Individual Swallows and Diagnoses Using High-Resolution Manometry (HRM) With Esophageal Pressure Topography (EPT): Results of Web-Based Studies With High Participation (1137a)
Topic Forum/Investigators: Mark R. Fox, John E. Pandolfino, Jafar Jafari, Dieter Menne, Ana T. Abreu, Auke Bogte, Alessandra Elvevi, Antonio Ruiz de Leon, Boudewijn F. Kessing, Lubomyr Boris, Jose M. Remes Troche, C. Prakash Gyawali, Candice L. Wilshire, Dorata Wasko-Czopnik, Francois Mion, Heiko Fruehauf, Frank Zerbib, Oliver Gellersen, Henriette Heinrich, Julio Perez de la Serna, Matthias M. Sauter, Gerrit J. Hemmink, Marcin Banasiuk, Miguel A. Valdovinos, Uscinowicz Miroslawa, Monika A. Kwiatek, Jeff Wright, Pim W. Weijenborg, Rami Sweis, Sabine Roman, Rukiye Vardar, Sudip K. Ghosh, Radu Tutuian, Wout O. Rohof, Albert J. Bredenoord
Time: 10:30 am

(Embargoed until May 19, 2012, 8 am PT)
Risk Stratification of Upper GI Bleeding With PillCam ESO Capsule (Sa1726)
Poster Presentation/Investigators: Sujievvan Chandran, Paul Urquhart, Adam Testro, Sim Ong, Edward Shelton, Richard La Nauze, Rhys Vaughan, William Kemp, Gregor J. Brown, Paul R. Froomes
Time: 8 am to 5 pm

(Embargoed until May 20, 8 am PT)
Extending BRAVO pH Monitoring Studies to Four Days: Patient Stratification Based on the Number of Positive Days (Su1100)
Poster Presentation/Investigators: Gabriela I. Escobar, Meghan Thompson, Meghan Barrett, Chang Lu, Lubomyr Boris, Peter J. Kahrilas, John E. Pandolfino
Time: 8 am to 5 pm

About 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, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19 - 22, 2012, at the San Diego Convention Center. The meeting showcases more than 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 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, industry-leading ManoScan™ high resolution manometry and Bravo® pH and Digitrapper® pH and impedance products. 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 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) 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 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.

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