Study Confirms Given Imaging's Bravo(R) pH Monitoring System to Be a Very Effective Diagnostic Tool for Assessing GERD

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Mon Jun 1, 2009 11:37am EDT

  CHICAGO, IL, Jun 01 (MARKET WIRE) -- 
Given Imaging Ltd. (NASDAQ: GIVN) today announced the results of a study
confirming that the Bravo pH Monitoring system delivered a definitive
GERD diagnosis in patients for whom previously administered
catheter-based pH monitoring tests proved inconclusive. Led by Rami
Sweis, of the Oesophageal Laboratory, Guy's and St. Thomas' Hospital in
London, the study (S1892) was presented during the annual Digestive
Disease Week(R) (DDW) 2009 conference taking place in Chicago from May 30
- June 4.

    "Had it not been for Bravo, many patients in this study would not have
received a GERD diagnosis," said Dr. Mark Fox, Consultant
Gastroenterologist at the University Hospital of Zuerich. "Wireless
monitoring improves several issues presented by traditional tests,
including tolerability, its effect upon daily activities and patient
compliance and the high day-to-day variability of esophageal acid
exposure. Greater tolerability allows us to expand the duration and
quantity of pH level data that we collect. The additional data enables us
to definitively rule out or confirm acid reflux as a cause of symptoms
and disease."

    The study enrolled 23 consecutive patients who had symptoms suggestive of
reflux but who previously had shown normal acid exposure and negative
symptom association when evaluated with traditional, catheter-based pH
monitoring systems. Researchers used standard esophageal acid measurements
to analyze total reflux, upright reflux and supine reflux. Acid exposure
over 24 hours was the primary outcome of the study. Key findings included:


--  More than 1 in 4 patients with a negative pH catheter study had
    pathological acid exposure during a 48-hour period of wireless pH
    monitoring.
--  Nearly 1 in 2 patients had at least one day of pathological exposure
    during a 96-hour period of wireless pH monitoring (total, upright or
    supine).
--  Prolonged monitoring also increased the number of patients with a
    significant association between reflux episodes and symptoms.
--  Follow-up showed that 6 of 7 patients with positive findings (acid
    exposure or symptom association) did well after anti-reflux surgery;
    whereas 6 of 7 patients with entirely negative findings failed to respond
    to medical therapy.
    

    
Researchers indicated that it is unclear as to whether average pH
measurement or the single-worst-day measurement is more clinically
relevant, noting that either approach increased the diagnostic yield in
this study.

    About the Bravo pH Monitoring System

    The catheter-free Bravo pH Monitoring System has improved pH testing by
using a capsule that collects pH data and transmits it via radio frequency
telemetry to a small, external, pager-sized receiver worn by the patient.
Like catheter-based pH tests, the Bravo pH Monitoring System is an
ambulatory method of pH monitoring, regarded as a gold standard because it
improves the collection of data by measuring pH in the normal daily
routine to assess if the patient has GERD.

    The Bravo system allows patients to maintain their regular diet and
activities. The Bravo system also minimizes throat and nasal discomfort
associated with conventional catheter-based pH systems, and, with little
visible indication that a pH test is taking place, Bravo pH monitoring
eliminates the social embarrassment that accompanies traditional pH
testing. By extending pH data collection to 48 hours, 24 hours beyond the
recording capability of conventional catheter systems, Bravo provides the
physician with additional data needed for an accurate GERD assessment. The
current study shows that Bravo increases the likelihood of GERD diagnosis
based on acid exposure and confirms that prolonged 48-hour monitoring
facilitates the documentation of relationships between symptoms and reflux
events, as reported first in a 2003 study published in The American
Journal of Gastroenterology(1). The Bravo system is the subject of more
than 50 peer-reviewed and industry publications.

    Traditional pH testing studies, sometimes combined with impedance
measurement, involve inserting a very small catheter into the nostril and
advancing it into the esophagus. Patients using the catheter method often
do not follow their usual daily schedule so the pH measurements may not be
predictive of GERD in the 24-hour testing period. Challenges to
traditional catheter based pH testing include throat irritation,
difficulty sleeping and discomfort during eating or drinking.

    About GERD

    Gastroesophageal reflux (also known as heartburn) occurs when contents
from the stomach flow back up into the esophagus. Occasional heartburn is
normal, but chronic heartburn caused by GERD can affect daily activities
and damage the esophagus. Left untreated, GERD may also lead to more
serious medical problems:


--  Difficulty swallowing (dysphagia)
--  Painful swallowing (odynophagia)
--  Narrowing of the esophagus (strictures)
--  Barrett's esophagus (pre-cancerous lesion)
--  Chronic hoarseness or laryngitis
--  Respiratory problems (coughing, asthma)
    

    
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 30 - June 4, 2009, at the McCormick Place, Chicago, IL. 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 2001 Given Imaging has advanced gastrointestinal diagnosis by
developing innovative, patient-friendly tools based on its PillCam(R)
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(TM) patency
capsule, to verify intestinal patency, and Bravo(R), 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 colon [PillCam COLON is not cleared for use in the USA.] 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
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"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) Am J Gastroenterol 2003;98(4):740-749. 

For further information contact:

Fern Lazar/David Carey
Lazar Partners Ltd.
1-866-GIVEN-IR
Email Contact/
Email Contact

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