Three Clinical Studies Confirm PillCam(R) ESO's Promise as a Screening Tool for Esophageal Varices in Cirrhotic
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SAN DIEGO, CA, May 20 (MARKET WIRE) --
Given Imaging Ltd. (NASDAQ: GIVN) today announced that data from three new
studies underscore the value of PillCam(R) ESO capsule endoscopy as a
valuable, patient-friendly tool for screening cirrhotic patients for
esophageal varices. One study will publish in the June 2008 issue of
Hepatology and two other abstracts were presented during the annual Digestive
Disease Week(R) (DDW) 2008 conference taking place in San Diego from May 17-22.
The current "gold standard" screening method, esophagogastroduodenoscopy
(also known as EGD or upper
endoscopy), is uncomfortable, invasive, costly and requires sedation, which may
limit adherence to screening programs, according to the study in Hepatology.
Fifty
percent of cirrhosis patients develop varices within 10 years(1). Twenty
percent
of patients who develop large varices die within six weeks(2).
Led by Roberto de Franchis, M.D., Head, Gastroenterology and GI endoscopy
Unit,
Ospedale Policlinico, Mangiagalli and Regina Elena Foundation, Milano at the
Department of Medical Sciences, University of Milan, the Hepatology study
assessed
the diagnostic performance of PillCam ESO using EGD as the gold standard.
While agreement between the two methods was 86%, the study did not meet its
primary endpoint of demonstrating equivalence to EGD within 10%. There was
significant agreement (91%) between the two methods with respect to specificity
in determining those patients who had large varices and those with small
varices, although sensitivity was lower at 78%. Overall, patients
significantly preferred PillCam ESO to EGD. The results of the study also
confirmed the utility of a standard scoring system to grade images of varices
captured with PillCam ESO, and the authors did note that in some instances,
grading by the capsule was thought to be more precise than EGD.
"Since patients rate capsule endoscopy as more comfortable and convenient,
broader
use of this tool may lead to better adherence to guidelines and ultimately
improve the outcomes if more patients undergo screening," said Dr. de Franchis.
A second study presented as a poster at DDW 2008, "Screening for
EsophagealVarices in End-Stage Liver Disease: Utility of Esophageal Capsule
Endoscopy,"
(Abstract #M1370) and led by Ayodele T Osowo, MD, and colleagues found that
PillCam Esophageal capsule endoscopy identified varices in 38% (83) of the 217
patients in a prospective study. PillCam also helped physicians diagnose
gastric
varices in 1.3% (3) of the patients and portal hypertensive gastropathy in 11%
(24).
"Our study shows that capsule endoscopy is a valuable screening tool for
esophageal varices in cirrhotic patients," said Dr. Osowo, fellow at the Mayo
Clinic in Scottsdale, Arizona. "Other findings in this study suggest it may
also
be useful for diagnosis of other co-existent esophageal and gastric
pathologies. Relative ease of ingestion and convenience may make this a more
attractive alternative for patients." Dr. Osowo presented the poster on
Monday, May 19 at DDW.
A third study presented at the DDW podium, "Randomized Controlled Trial of
Esophageal Capsule Endoscopy Versus Standard Endoscopy for Screening in
Patients Pre-Liver Transplantation. Assessment of Inter-Observer Variability and
Patient
Preferences," (Abstract #472), presented by lead author Lauren B. Gerson MD,
MSc from Stanford Unversity School of Medicine, compared PillCam ESO's
diagnostic
results to EGD in 24 patients awaiting liver transplants. An expert hepatologist
performed the EGDs. Two blinded independent faculty experts interpreted ECE
images.
EGD detected varices in 12 (50%) of the patients and PillCam ESO found
varices
in 11 (46%) of them. Varices were graded as F1=small straight varices;
F2=enlarged tortuous varices < 1/3 of the lumen; and F3=large coil-shaped
varices
greater than or equal to 1/3 lumen. Both methods detected significant (grade
F2-F3) varices in 8 patients. The EGD and PillCam ESO readers demonstrated
100% agreement for small varices (Grades F0/F1) and agreed 88% of the time for
the higher grade (F2/F3) varices. A majority of the patients (61%)
preferred PillCam endoscopy over EGD (9%), and patients reported less
discomfort (p=0.03), greater satisfaction (p=0.03) and less fatigue (p < 0.001)
associated with the ECE examination compared to standard EGD.
"In patients awaiting a liver transplantation who are undergoing screening
for the
presence of esophageal varices, PillCam capsule endoscopy was sensitive,
specific, and preferred by patients compared to standard sedated endoscopy,"
said
Dr. Gerson, Associate Professor of Medicine at Stanford University. "There was
also good agreement between capsule endoscopy experts regarding the grading of
varices. If the goal of endoscopic screening is to identify patients with large
varices who can undergo subsequent endoscopic or medical therapy, our study
demonstrated that all of the patients at high risk of bleeding from
esophageal varices would have been identified accurately by esophageal capsule
endoscopy. By using PillCam ESO to screen for varices, the majority of
patients with advanced liver disease can be spared the discomfort and time
associated with standard upper endoscopy, and potentially the risk of
exacerbation of underlying encephalopathy associated with the usage of
conscious sedation."
"We are encouraged by the growing body of data supporting PillCam ESO," said
Homi Shamir, president and CEO, Given Imaging. "Since our inception, Given
Imaging
has sought to redefine gastrointestinal diagnosis by developing, producing
and marketing innovative, patient-friendly products for detecting
gastrointestinal
disorders. Studies such as these confirm the value of PillCam products."
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 over $2 billion a
year according to 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
theblood from flowing through the liver. This can cause the veins in the
esophagus to enlarge. It's vital to monitor for the appearance of these
enlarged veins, or varices, and to keep track of their size. Roughly one-fourth
of these varices eventually start to bleed and 10% to 20% of patients die
within six weeks of the bleeding episode.
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
asBarrett's esophagus, a potential precursor for esophageal cancer and
esophageal varices, which if left untreated, can result in fatal bleeding.
PillCam
ESO contains imaging devices and light sources at both ends of the capsule
that capture up to 14 images per second, a total of 2,600 color images, 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
forthe 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 17-22, 2008, at
the San Diego Convention Center, San Diego, CA. 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.
Given Imaging is redefining gastrointestinal diagnosis by developing,
producing and
marketing innovative, patient-friendly products for detecting gastrointestinal
disorders. The company's technology platform is the PillCam(R) Platform,
featuring the PillCam video capsule, a disposable, miniature video camera
contained
in a capsule, which is ingested by the patient, a sensor array, data recorder
and RAPID(R) software. Given Imaging has a number of available capsules: the
PillCam SB video capsule to visualize the entire small intestine which is
currently marketed in the United States and in more than 60 other countries;
the PillCam ESO video capsule to visualize the esophagus; the Agile(TM) patency
capsule to determine the free passage of the PillCam capsule in the GI tract
and the PillCam COLON video capsule to visualize the colon that has been
clearedfor marketing in the European Union. PillCam COLON has received a CE
Mark, but
is not cleared for marketing or available for commercial distribution in the
USA. More
than 700,000 patients worldwide have benefited from the PillCam capsule
endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D
facilities are
located in Yoqneam, Israel. It has operating subsidiary companies in the
United States, Germany, France, Japan, Australia and Singapore. Given Imaging's
largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN).
For
moreinformation, visit http://www.givenimaging.com.
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) satisfactory results of clinical trials
with PillCam COLON (2) our ability to receive regulatory clearance or approval
to market our products or changes in regulatory environment, (3) our success
inimplementing our sales, marketing and manufacturing plans, (4) protection and
validity of patents and other intellectual property rights, (5) the impact of
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the outcome of future litigation, including patent litigation with Olympus
Corporation, (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, and (11) other risks and factors disclosed in our filings with the
U.S. Securities and Exchange Commission, including, but not limited to, risks
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factors identified under such headings as "Risk Factors," "Cautionary Language
RegardingForward-Looking Statements" and "Operating Results and Financial Review
andProspects" in the Company's Annual Report on Form 20-F for the year ended
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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) D'Amico G, Pasta L, Madonia S, et al. The incidence of esophageal
varices in cirrhosis. Gastroenterology 2001;120:A2.
(2) 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
Email Contact
David Carey
Email Contact
Lazar Partners Ltd.
1-866-GIVEN-IR
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