SOURCE: Given Imaging

Given Imaging

May 03, 2011 07:01 ET

Extensive New Data Supporting the Use of Given Imaging Products to Be Presented at Digestive Disease Week 2011

Company Will Also Unveil Next-Generation ManoScan™ 3D and Digitrapper® Products

YOQNEAM, ISRAEL--(Marketwire - May 3, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that more than 150 podium and poster sessions featuring the Given Imaging product lines will be presented at the upcoming Digestive Disease Week (DDW). Included in these sessions is podium presentation #671, highlighting new data from a European multicenter study to assess the feasibility of PillCam® COLON 2* in a head-to-head comparison with colonoscopy. DDW takes place from May 7 to 10, 2011 at the McCormick Place Convention Center in Chicago, IL. Given Imaging will be exhibiting at booth #2143 throughout the conference.

At this year's DDW, clinicians will present data from studies evaluating Given Imaging's products including the PillCam® Platform, Bravo® pH Monitoring System, ManoScan™ High Resolution Manometry Platform and Digitrapper® pH System. All data presented at DDW will be embargoed until the time of presentation. Podium presentation highlights include:

  • Capsule Endoscopy (CE) in Persons Presenting With Acute Upper Gastrointestinal Hemorrhage (UGIH) - A Prospective Cohort Study (#233) on Saturday, May 7th at 2:45 pm;
  • The Effect of Treatment on High-Resolution Esophageal Pressure Topography (EPT) Achalasia Subtype (#363) on Sunday, May 8th at 8:45 am;
  • Second-Generation PillCam COLON Capsule Compared With Colonoscopy (#671) on Monday, May 9th at 8:45 am;
  • A Prospective Multicenter Blinded Cohort Study Comparing Diagnostic Yield of Capsule Endoscopy (CE) Prior to Ileocolonoscopy (IC) Compared to Small Bowel Follow Through (SBFT) Prior to IC in Patients With Suspected Crohn's Disease (CD) (#852) on Monday, May 9th at 4:45 pm.

The Given Imaging booth will feature two new products in its growing reflux and manometry portfolio, the ManoScan 3D anorectal manometry system and new Digitrapper pH-Z recorder. Additionally, the Company will launch the new Given® Connectivity Solution, enabling HL7 and DICOM interface between Given Imaging software and medical information systems. Given Imaging staff will be on hand to discuss the expanded PillCam SB indications and new pediatric indications for Bravo pH monitoring, both announced earlier this year.

*PillCam® COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA.

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 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 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) 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.

Contact Information