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Investigators Suggest PillCam(R) SB as First-Line Diagnostic Tool for High Risk Celiac Disease Patients
Study Shows PillCam SB Provides Well Defined Visualization of the Villous Pattern and Proves Accurate in Identifying Celiac Markers
| Source: Given Imaging
YOQNEAM, ISRAEL and SAN DIEGO, CA--(Marketwire - May 18, 2008) - Given Imaging Ltd.
(NASDAQ : GIVN ) today announced a study presented at the Digestive Disease
Week® (DDW) 2008 conference this week determined that capsule endoscopy
is a non-invasive, patient-friendly tool that provides good quality images
of the small bowel mucosa and enables physicians to identify endoscopic
markers of celiac disease (CD) as accurately as standard endoscopy. Led by
Cristiano Spada, MD, Digestive Endoscopic Unit of the Catholic University
in Rome, study investigators suggest PillCam SB as a first-line diagnostic
tool in high risk CD patients.
"Capsule endoscopy with PillCam SB provides clear visualization of the
villous patterns and accurately records endoscopic markers associated with
celiac disease. This patient-friendly option is of particular relevance to
high-risk patients and should be considered as a first-line diagnostic
tool," said Dr. Spada.
The aim of the study was to evaluate if capsule endoscopy could play a role
in the diagnosis of CD and serve as an alternative method for villous
atrophy evaluation. Both esophagogastroduodenoscopy (EGD) and capsule
endoscopy with PillCam SB showed the presence of at least one endoscopic
marker in 31 out of 42 patients. PillCam SB identified thirty-eight (38/42)
patients with villous atrophy and also found endoscopic markers of CD in
22/24 (91.6%) of Marsh III patients. The Marsh classification is a
methodology for describing the changes which affect the villi of the small
intestine when affected by CD. Marsh scores range from 0 (normal mucosa) to
IV (hypoplasia of the small bowel). Marsh III indicates partial or complete
villous atrophy. Both EGD and PillCam SB capsule endoscopy showed normal
results in the remaining patients. Thirty-one (31) patients had mucosal
changes beyond the proximal jejunum, and 2 patients had an extension up to
the ileum.
The 42-patient study used EGD and PillCam capsule endoscopy of the small
bowel to evaluate patients with positive serology studies prospectively.
Capsule endoscopy findings were evaluated for the presence of endoscopic
markers suggestive of CD, such as scalloping, nodular mucosa, reduction of
duodenal folds or a mosaic pattern and villous atrophy.
This study confirms the current ICCE guidelines and the growing body of
clinical evidence that supports the use of CE to diagnose and screen
patients who are sero-positive for CD. The ICCE guidelines also recommend
CE use in patients who are symptomatic on a gluten-free diet. Capsule
endoscopy is especially indicated as an adjunctive method for patients
presenting with alarm symptoms such as weight loss, fever and pain (1).
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) Mergener, Literature Review and Recommendations For Clinical
Application of Small Bowel Capsule Endoscopy Based on a Panel of
International Experts: Endoscopy, Vol.39, October 2007