SAN DIEGO, CA--(Marketwire - May 20, 2008) - Given Imaging Ltd. (
NASDAQ:
GIVN) today
announced that data from three new studies underscore the value of
PillCam® 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® (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 Esophageal
Varices 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 the
blood 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 as
Barrett'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 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 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® 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® 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™ 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 cleared
for 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 more
information, 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 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 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 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, 2007. 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) 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
Contact Information: For further information contact:
Fern Lazar
David Carey
Lazar Partners Ltd.
1-866-GIVEN-IR