Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-866-GIVEN-IR
New Studies Show PillCam(R) SB to Be Clinically Valuable in Classifying and Managing Pediatric GI Symptoms
CE Findings Change the Therapeutic Management of Children With Crohn's Disease
| Source: Given Imaging
LONDON--(Marketwire - November 24, 2009) - Given Imaging Ltd. (NASDAQ : GIVN ), the global leader
in patient-friendly GI diagnostic and monitoring solutions, today announced
three new studies that demonstrate the clinical utility of PillCam SB
capsule endoscopy in providing physicians with critical information on how
they manage and/or diagnose intestinal disorders. These novel studies were
carried out in pediatric patients with gastrointestinal symptoms, including
children with known or suspected Crohn's disease. The three 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.
In presentation # OP182, Professor Annette Fritscher-Ravens, Department of
Interdisciplinary Endoscopy, University Hospital Kiel, Germany, concluded
that physicians should consider wireless capsule endoscopy exams for
children under eight years of age when other diagnostic methods failed to
identify the cause of their GI symptoms. Physicians participating in this
study changed the clinical management 100 percent of the time when capsule
endoscopy studies revealed pathology. The study also concluded that
negative findings may be as useful as positive findings in influencing the
patient management plan.
"Capsule endoscopy is a powerful, non-invasive imaging modality that can
impact pediatric patient outcomes," said Dr. Fritscher-Ravens. "If no cause
for symptoms can be determined, capsule endoscopy should always be
considered, as both positive and negative findings from CE exams have led
us to change how we manage pediatric patients, which often improves their
quality of life."
The second, a poster presentation (P1369) led by Dr. Ernest G. Seidman,
Professor of Medicine and Chair of IBD at McGill University Health Center,
Montreal, Canada, concluded that capsule endoscopy is clinically useful in
symptomatic pediatric patients with known Crohn's disease when endoscopic
and barium studies are negative. As a result of the CE findings, study
investigators changed how they clinically managed more than half of the
patients in the study.
"For those children with Crohn's disease who still experience symptoms, we
have learned capsule endoscopy findings can alter the way we manage their
disease," said Dr. Seidman. He went on to state, "This included important
management decisions, such as using anti-TNF monoclonal antibody therapy
rather than proceeding with surgery."
A third poster presentation (P0195) led by Salvatore Cucchiara, MD, PhD,
Pediatric Gastroenterology Unit, Sapienza University of Rome, concluded
that information from PillCam SB procedures can help classify IBD as
either Crohn's disease, ulcerative colitis or unclassified IBD among
children. These results were determined to have important clinical and
therapeutic implications.
"Children remain an important patient group for whom accurate diagnosis and
treatment can significantly impact their lives, and we are pleased that
these studies validate PillCam SB's broader role in their diagnosis and
management," said Homi Shamir, President and Chief Executive Officer, Given
Imaging.
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.(5)
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.
The PillCam SB 2 video capsule, when used with the PillCam Platform, is
intended for visualization of the small bowel mucosa. It may be used as a
tool in the detection of abnormalities of the small bowel in adults and
children from two years of age and up. The PillCam SB 2 capsule and the
PillCam Platform are not cleared for children younger than two years old
and should not be used outside of the context of approved clinical trials
with such patients.
Study # OP182 was partly supported by Given Imaging.
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) http://qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease
Frequently Asked Questions
(2) Crohn's and Colitis Foundation of America (www.ccfa.org)
(3) National Institute of Diabetes and Digestive and Kidney Diseases
(www.niddk.nih.gov)