News
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%...).
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%...).
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.
