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Studies Investigate Use in Targeted Patient Populations; Data Also Confirm Clinical Benefits of Key Technological Advances including QuickView + Suspected Bleeding Indicator, Motil...

Tue, 05/22/2012 - 7:45am
The Associated Press

(http://www.givenimaging.com)

Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products

and pioneer of capsule endoscopy, today announced new data on

recommendations for early use of PillCam SB, as well as new

technological advances. Given Imaging also announced new studies

confirming PillCam@ SB's benefits in several specialized patient

populations, including octogenarians and those with neutropenic

cancer, for whom the minimally-invasive procedure might be a safer

alternative to other diagnostic methods. The studies are being

presented at the American Society for Gastrointestinal Endoscopy

(ASGE) Research Forum at Digestive Disease Week@ (DDW), taking place

May 19 - 22 in San Diego.

Data on Earlier Use of PillCam SB

Data on Specialized Patient Populations

New Technological Advances

About PillCam@ SBThe 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 1,500 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 Digestive Disease WeekDigestive 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(http://ctt.marketwire.com/?release=890116&id=1633648&type=1&url=http%3a%2f%2fwww.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@ pH and

Digitrapper@ pH and impedance monitoring. 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(http://ctt.marketwire.com/?release=890116&id=1633651&type=1&url=http%3a%2f%2fwww.givenimaging.com%2f).

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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