-- Seven of 12 showed positive signs of bleeding
-- Four patients' actual lesions were visualized in real time
-- Two patients' lesions were visualized at download
-- Five of 12 showed no signs of bleeding
-- Four patients had no stigmata at EGD following the capsule endoscopy
-- One patient did not undergo EGD due to co-morbidities
The study included 14 males and 10 females, with an average age of 66
years.
Upper GI Bleeding
Upper GI bleeding can result from a variety of causes, including peptic
ulcer disease, hemorrhagic gastritis, gastroesophageal varices and
Mallory-Weiss syndrome, and is defined as bleeding above the ligament of
Treitz, between the duodenum and jejunum. Regardless of the cause of
bleeding, a rapid clinical assessment is critical. Acute upper GI bleeding
is one of the most common medical emergencies, responsible for
approximately 300,000 hospitalizations each year with a mortality rate
close to 10 percent.(1)
Moshe Rubin, M.D., was a co-author of the study and is a consultant to
Given Imaging. Given Imaging supported this research through an industry
grant in the form of PillCam ESO capsules, valued at $6,000.
About PillCam ESO
Cleared by the U.S. Food and Drug Administration in November 2004 to
visualize the esophagus in adult patients in a patient-friendly way,
physicians can use PillCam ESO to aid in the detection of disorders of the
esophagus. Now in its second generation, PillCam ESO 2 contains imaging
devices and light sources at both ends of the capsule that capture up to 18
images per second as it passes down the esophagus in a twenty-minute
procedure.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal diagnosis by
developing innovative, patient-friendly tools based on its PillCam®
Platform. PillCam capsule endoscopy provides physicians with natural images
of the small intestine via PillCam SB, the esophagus through PillCam ESO
and the colon with PillCam COLON [not cleared for use in the USA]. The
PillCam capsules are miniature video cameras that patients ingest. Given
Imaging's other capsule products include Agile™ patency capsule, to
verify intestinal patency, and Bravo®, the only wireless, catheter-free,
48-hour pH test commercially available for pH testing to assess
gastroesophageal reflux disease (GERD). Given Imaging's products use
cutting-edge, wireless technology and advanced software to enable
gastroenterologists to better diagnose diseases of the esophagus, small
bowel and and more accurately treat patients. All Given Imaging products
allow patients to maintain normal activities. Given Imaging's headquarters,
manufacturing and R&D facilities are located in Yoqneam, Israel, with
operating subsidiaries in the United States, Germany, France, Japan,
Australia and Singapore. For more information, please visit
http://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 receive regulatory clearance or approval to market our
products or changes in regulatory environment, (3) our success in
implementing our sales, marketing and manufacturing plans, (4) protection
and validity of patents and other intellectual property rights, (5) the
impact of currency exchange rates, (6) the effect of competition by other
companies, (7) the outcome of significant litigation, (8) our ability to
obtain reimbursement for our product from government and commercial payors,
(9) quarterly variations in operating results, (10) the possibility of
armed conflict or civil or military unrest in Israel, (11) the impact of
global economic conditions, and (12) 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, 2008. 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.
(1) Krumberger, Joanne M. RN, MSN, FAAN. How to manage an acute upper GI
bleed. RN/Thomson AHC Home Study Program CE CENTER. March 1, 2005.
http://rn.modernmedicine.com/rnweb/article/articleDetail.jsp?id=150046
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-866-GIVEN-IR