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Three Studies Find PillCam(R) SB Enables Earlier Diagnosis and Treatment of GI Diseases Including Crohn's
| Source: Given Imaging
LONDON--(Marketwire - November 25, 2009) - Given Imaging Ltd. (NASDAQ : GIVN ), the global leader
in patient-friendly GI diagnostic and monitoring solutions, today announced
that three new studies demonstrate that PillCam® SB endoscopy has a clear
impact on how physicians manage GI patients, including those patients
suspected of having Crohn's disease. The studies were presented at the
Gastro 2009 conference taking place in London from November 21 to 25. Given
Imaging is exhibiting at booth #83 at the conference.
A 950-patient, single-center study (P2106) analyzing the largest series of
capsule endoscopy cases from the UK, led by Dr. Mark E. McAlindon,
Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, UK,
examined capsule endoscopy's diagnostic yield and impact on patient
management. Results of the study showed that using PillCam SB changed how
physicians treated 27 percent of all patients and 79 percent of patients
who were subsequently diagnosed with Crohn's disease.
In a poster presentation (P2105), Jorge Cotter, Alto Avenue Hospital
Center, in Guimarães, Portugal, concluded that physicians can diagnose and
classify Crohn's disease earlier by using PillCam SB. The study also found
that based upon capsule endoscopy findings, physicians changed their
therapeutic strategy for 22 percent of their patients.
Finally, data from a poster (P1471) presented by Paul Thomas, Consultant
Gastroenterologist, Musgrove Park Hospital in Somerset, UK, showed that by
using PillCam SB, physicians at community hospitals were able to
definitively determine the source of GI bleeding in 58 percent of patients
who presented with obscure gastrointestinal bleeding (OGIB) and
subsequently treated more than one-third of those examined. These results
mirror results seen in large, tertiary referral centers. Thomas and
colleagues concluded that a normal capsule endoscopy indicates a good
prognostic course.
"There is a growing body of evidence that suggests broader use of wireless
capsule endoscopy in routine practice," said Dr. Thomas. "Earlier diagnosis
and management at the point-of-care may improve patient outcomes."
About Crohn's Disease
Crohn's disease is a chronic condition that causes inflammation in the
lining of the small intestine wall. It usually occurs in the lower part of
the small intestine called the ileum, but can affect any part of the
digestive tract. Symptoms can include diarrhea, abdominal pain, weight loss
and rectal bleeding. Roughly 50 percent of all cases of Crohn's disease are
diagnosed in the last part of the small intestine (the terminal ileum) and
cecum. This area is also known as the ileocecal region. Other cases of
Crohn's may affect one or more of the following: the colon only, the small
bowel only (duodenum, jejunum and/or ileum), the stomach or esophagus.(1)
Roughly 500,000 Americans suffer from Crohn's disease, and about 20 percent
have a direct relative with some form of inflammatory bowel disease
(IBD).(2) It affects men and women equally. The cause is unknown, but the
theory most widely held is that the immune system is over-reacting to a
virus or bacterium that causes inflammation.(3) An upper GI endoscopy,
upper GI radiography series and colonoscopy are often used to test for
inflammation and intestinal abnormalities. Depending on the severity,
treatment options include nutritional supplements, drugs and surgery.
There is currently no cure for the disease.
About PillCam SB
The PillCam SB video capsule measures 11 mm x 26 mm and weighs less than
four grams. Now in its second generation, PillCam SB 2 contains an imaging
device and light source and transmits images at a rate of two images per
second generating more than 50,000 pictures during the course of the
procedure. Initially cleared by the U.S. Food and Drug Administration in
2001, PillCam SB is clinically validated by more than 1,100 peer-reviewed
studies. It is the most accurate, patient-friendly tool for visualization
of the small bowel and is used by physicians to evaluate patients with a
variety of diseases of the small bowel.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal diagnosis by
developing innovative, patient-friendly tools based on its PillCam®
Platform. PillCam capsule endoscopy provides physicians with natural images
of the small intestine via PillCam SB, the esophagus through PillCam ESO
and the colon with PillCam COLON [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™ patency capsule, to
verify intestinal patency, and Bravo®, 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 diseases 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.
Forward-Looking Statements
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) our ability to develop and bring to market new products, (2)
our ability to successfully complete any necessary or required clinical
studies with our products, (3) our ability to receive regulatory clearance
or approval to market our products or changes in regulatory environment,
(4) our success in implementing our sales, marketing and manufacturing
plans, (5) the level of adoption of our products by medical practitioners,
(6) the emergence of other products that may make our products obsolete,
(7) lack of an appropriate bowel preparation materials to be used with our
PillCam COLON capsule, (8) protection and validity of patents and other
intellectual property rights, (9) the impact of currency exchange rates,
(10) the effect of competition by other companies, (11) the outcome of
significant litigation, (12) our ability to obtain reimbursement for our
product from government and commercial payors, (13) quarterly variations in
operating results, (14) the possibility of armed conflict or civil or
military unrest in Israel, (15) the impact of global economic conditions,
and (16) 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, 2008. 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) qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease Frequently
Asked Questions
(2) Crohn's and Colitis Foundation of America (ccfa.org)
(3) National Institute of Diabetes and Digestive and Kidney Diseases
(niddk.nih.gov)