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Given Imaging Announces New Mayo Clinic Study Concludes Celiac Disease May Be More Severe Than Symptoms Indicate for Some Patients
PillCam(R) SB Visualizes Disease Severity, Guides Treatment and Provides Better Sensitivity for the Detection of Villus Atrophy
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - March 3, 2008) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that a study by researchers at the Mayo Clinic reported that
capsule endoscopy is a more effective tool to diagnose celiac disease and
detect damage throughout the small intestine than upper endoscopy.
Researchers also found that celiac affects a highly variable portion of the
small intestine and that the severity of symptoms did not correlate to the
severity of intestinal damage.
The Mayo study utilizing Given Imaging's PillCam SB was led by Mayo Clinic
gastroenterologist Joseph Murray, M.D. and appears in this month's issue of
Clinical Gastroenterology and Hepatology.
"We're pleased that this study confirms that PillCam SB, which has the
advantage of visualizing the entire small bowel, can help clinicians
diagnose and monitor the severity of celiac disease regardless of their
patient's symptoms," said Homi Shamir, CEO of Given Imaging.
According to the Mayo Clinic, this study, which is the first of its kind,
used capsule endoscopy to view intestinal damage in 38 patients with
untreated, biopsy-proven celiac disease. Indications for clinical
evaluation were malabsorption syndrome and iron deficiency anemia.
Ninety-two percent had visible damage detected by capsule endoscopy while
upper endoscopy only detected visible damage in 55% of the patients.
Neither capsule endoscopy nor upper GI series yielded false positives.
This study also indicated that a high proportion of adults may not heal
their intestinal abnormalities even after a year or more on a gluten-free
diet. Biopsy specimens of the proximal small bowel alone may not reflect
the healing that has occurred distally in response to a gluten-free diet.
Capsule endoscopy showed that healing in the small intestine occurred from
the distal to the proximal direction with most residual changes remaining
in the duodenum. Capsule endoscopy may play a role in monitoring the
healing process of a patient on a gluten-free diet.
Given Imaging's PillCam SB video capsule was the first capsule endoscope on
the market designed specifically to help doctors see inside all 30-feet of
the small bowel (small intestine) to diagnose disorders such as Crohn's
disease, Celiac disease, benign and cancerous tumors, ulcerative colitis as
well as others disorders.
The smooth plastic capsule contains a miniature video camera and is
equipped with a light source on one end, batteries, a radio transmitter and
antenna. After it is swallowed, the PillCam SB capsule transmits
approximately 50,000 images over the course of an 8-hour period (about 2
images per second) to a data recording device attached to a belt worn
around the patient's waist. The small bowel images are then downloaded into
a Given® Workstation computer where a physician can review the images in
order to make a diagnosis.
About Celiac Disease
Celiac disease interferes with absorption of nutrients and is an autoimmune
disorder of the small intestine. In celiac, gluten, found in all forms of
wheat and some related grains, creates a reaction that damages the mucosal
surface of the small intestine. Symptoms can include recurrent bloating,
gas or abdominal pain; chronic diarrhea or constipation; unexplained
anemia; fatigue, weakness or lack of energy; and others. Without treatment,
damage to the small bowel can be chronic and life-threatening. One in 133
people is affected by celiac disease.(1)
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 650,000 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
and Australia. 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, 2006. 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) Celiac Disease Foundation, www.celiac.org