Study Concludes PillCam ESO(R) Correlates Well With EGD in Detecting and Grading Esophageal Varices -- A Potentially

CHICAGO, IL, Jun 01 (MARKET WIRE) --
Given Imaging Ltd. (NASDAQ: GIVN) today announced the results of a study
showing that capsule endoscopy with PillCam(R) ESO demonstrated good
correlation with upper endoscopy as a tool to diagnose and grade
esophageal varices (EVs), a potentially lethal complication of advanced
liver disease. In addition, since PillCam ESO requires no sedation and is
substantially less invasive than esophagogastroduodenoscopy (EGD), study
investigators suggested that patients may be more willing to comply with
the need to get screened regularly to prevent potentially lethal
gastrointestinal hemorrhage. Neil R. Sharma, M.D., Division of Digestive
Diseases and Nutrition, University of South Florida in Tampa, presented
the findings in a poster presentation (#S1829) at the annual Digestive
Disease Week(R) (DDW) 2009 conference, taking place in Chicago from May
30 - June 4.

"Detecting and monitoring varices is critical in this patient population,"
said Dr. Neil R. Sharma. "Requiring no sedation, esophageal capsule
endoscopy provides a less invasive but equally effective option for the
screening of esophageal varices."

The current standard of care for screening, esophagogastroduodenoscopy,
also called EGD or "upper endoscopy," is invasive and requires sedation,
which may limit adherence to screening programs(1). Fifty percent of
cirrhotic patients develop varices within 10 years(2). Ten to twenty
percent of patients whose varices hemorrhage, or bleed, die within six
weeks(3).

About the Study

This prospective study enrolled 34 patients with end-stage liver disease
who underwent esophageal capsule endoscopy and EGD on the same day. Each
capsule endoscopy study was evaluated by a gastroenterologist experienced
in reading and interpreting these studies, and physicians were blinded to
the results. EVs were graded as absent, small, medium or large. EGD was
considered to be the gold standard for the purposes of the study. Key
findings included:

-- Esophageal capsule endoscopy had sensitivity and specificity of 100
and 66.7 percent, respectively, compared to EGD in the detection of
esophageal varices;
-- Complete agreement of EV grade occurred in 73.5 (25 of 34) percent of
cases;
-- Two of twelve patients whose EV were evaluated as "medium" or "large"
by capsule endoscopy were evaluated to be "small" using EGD; 1 of 18
patients whose EV was evaluated as "small" using esophageal capsule
endoscopy was evaluated as "medium" with EGD;
-- Evaluation of stigmata, a specific diagnostic sign of potential
bleeding, with capsule endoscopy showed sensitivity and specificity of 92.6
and 85.7 percent, respectively; and
-- Based on minimal invasiveness, lack of need for sedation, less
discomfort and fewer side effects, ESO may be a more desirable procedure
for cirrhotic patients that need EV screening.

About Esophageal Varices

Chronic liver disease affects 360 out of every 100,000 people in the U.S.,
results in 300,000 hospitalizations annually and costs more than $2
billion a year, according to the National Institutes of Health. The two
most common diseases leading to varices are cirrhosis and fibrosis of the
liver. In cirrhosis of the liver, scar tissue replaces normal, healthy
tissue, blocking the flow of blood through the organ and preventing it
from working as it should. Portal hypertension and esophageal varices
(enlarged veins) are two of the main complications of the disease.

In advanced cases of liver cirrhosis, scar tissue spreads and restricts
the blood from flowing through the liver. This can cause the veins in the
esophagus to enlarge. It is vital to monitor for the appearance of these
enlarged veins, or varices, and to keep track of their size.

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 such
as Barrett's esophagus, a potential precursor for esophageal cancer and
esophageal varices, which if left untreated, can result in fatal bleeding.
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 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(R) SB, the esophagus through
PillCam(R) ESO, and the colon with PillCam(R) COLON [PillCam COLON is 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
disease 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.

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(1) Roberto de Franchis, M.D., et al., Esophageal Capsule Endscopy for
Screening and Surveillance of Esophageal Varices in Patients with Portal
Hypertension.et al., Hepatology 2008; 47: 1595-1603.

(2) D'Amico G, Pasta L, Madonia S, et al. The incidence of esophageal
varices in cirrhosis. Gastroenterology 2001;120:A2.

(3) D'Amico G, de Franchis R, and the Cooperative Study Group. Upper
digestive bleeding in cirrhosis: post-therapeutic outcomes and prognostic
indicators. Hepatology 2003;38:599-612.

For further information contact:

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

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