Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced the
results of new studies confirming the value of using PillCam SB to
detect lesions indicative of Crohn's disease, as well as to monitor
disease progression in patients with suspected and known Crohn's
disease. The studies were presented at Digestive Disease Week (DDW)
2011, taking place May 7th - 10th at the McCormick Place Convention
Center. Given Imaging is exhibiting at booth #2143 at the
conference.
"Capsule endoscopy has long been the standard for detecting
obscure gastrointestinal bleeding of the small bowel. Recently,
several new clinical studies have highlighted the value of PillCam
SB for visualizing lesions in patients with suspected or known
Crohn's disease," said Stanley Cohen, MD, of the Children's Center
for Digestive Healthcare in Atlanta, Georgia. "We have also learned
that there is significant value in using PillCam SB to monitor the
progression of Crohn's disease and to determine if patients are
responding to therapy or if a change in treatment is required. We
are obtaining new information from the PillCam SB procedure that we
can utilize to ensure we are providing optimal ongoing treatment
for each patient with Crohn's disease."
Three poster presentations determined that new data acquired
during capsule endoscopy procedures in patients with suspected and
known Crohn's disease led to changes in how physicians treated
patients:
- Jonathan Leighton, MD, Division of Gastroenterology, Mayo
Clinic, Scottsdale, AZ, presented results of a study, abstract Sa1051, which showed that using capsule
endoscopy, prior to colonoscopy and SBFT, impacts disease
management. The prospective multicenter blinded cohort study of 74
patients with suspected small bowel Crohn's disease found that
capsule endoscopy altered disease management in 32% of patients, as
compared to 23% and 14% for colonoscopy and SBFT, respectively. Of
the 32% of patients whose disease management was altered due to
capsule endoscopy findings, 88% changed medication.
- Erika Boroff, MD, Instructor in Medicine, Department of
Community Internal Medicine, Mayo Clinic, Scottsdale, presented a
retrospective review on the change in disease management as a
result of capsule endoscopy findings in 114 patients with suspected
and established Crohn's disease, in abstract
Mo1525. Capsule endoscopy resulted in a
surgical or medical disease management change in 27 of 114 or 38.7%
of patients.
- A third retrospective study of 732 pediatric patients,
abstract Mo1560, concluded that capsule
endoscopy can improve the diagnosis and evaluation of the extent
and severity of Crohn's disease in pediatric patients. Stanley
Cohen, MD, Children's Center for Digestive Healthcare of Atlanta,
Children's Healthcare of Atlanta, and colleagues also found that
PillCam SB was effective in assisting physicians in guiding patient
management in the pediatric population.
In his podium presentation of abstract
#852, Rami Eliakim, MD, Chair of Medicine and
Director of the Department of Gastroenterology at Rambam Health
Care Campus, Haifa, Israel, presented key findings from a
prospective multicenter study of 80 patients, underscoring that
PillCam SB was superior to small bowel follow through (SBFT), a
radiological exam of the small bowel, to visualize suspected
lesions indicative of Crohn's disease. Furthermore, capsule
endoscopy achieved the same diagnostic yield as colonoscopy, the
standard for diagnosing small bowel Crohn's disease. The study also
determined that the combination of capsule endoscopy with
colonoscopy had a significantly higher diagnostic yield (97.3%) for
detecting lesions compared to small bowel follow through with
colonoscopy (57.3%). The researchers concluded that capsule
endoscopy appears to be a better diagnostic tool than SBFT for
suspected Crohn's disease.
About Crohn's Disease Crohn's disease is a
chronic condition that causes inflammation in the lining of the
small intestine wall and can affect any part of the digestive
tract. Symptoms can include diarrhea, abdominal pain, weight loss
and rectal bleeding. Roughly 50% 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% have a direct relative with some
form of inflammatory bowel disease (IBD)(2). Crohn's disease
affects men and women equally. The cause is unknown; but, the most
popular theory is that the immune system is reacting to a virus or
bacterium that causes inflammation(3). Depending on the severity,
treatment options include nutritional supplements, drugs and
surgery. There is currently no cure for the disease(4).
About Digestive Disease Week Digestive
Disease Week (DDW) is the largest international gathering of
physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. DDW is 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. 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 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 1,500 peer-reviewed studies. It is an accurate,
patient-friendly tool used in patients two years and older by
physicians to visualize the small bowel. PillCam SB is the gold
standard in small bowel evaluation.
All medical procedures carry some risks. The risks of PillCam®
capsule endoscopy include capsule retention, aspiration, or skin
irritation. The risks of the Agile™ GI patency test include capsule
retention and aspiration. Endoscopic placement may present
additional risks. Medical, endoscopic, or surgical intervention may
be necessary to address any of these complications, should they
occur.
About Given Imaging Ltd. Since pioneering
the field of capsule endoscopy in 2001, Given Imaging has become a
world leader in GI medical devices, offering health care providers
a range of innovative options for visualizing, diagnosing and
monitoring the digestive system. The company offers a broad product
portfolio including PillCam® video capsules for the small bowel,
esophagus and colon [PillCam® COLON not approved for use in the
United States], industry-leading ManoScan™ high-resolution
manometry and Bravo® wireless and Digitrapper® pH and impedance
products. Given Imaging is committed to delivering breakthrough
innovations to the GI community and to supporting its ongoing
clinical needs. Given Imaging's headquarters are located in
Yoqneam, Israel, with operating subsidiaries in the United States,
Germany, France, Japan, Australia, Vietnam and Hong Kong. For more
information, please visit 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, (16) our ability to
successfully integrate acquired businesses, (17) changes and
reforms in applicable healthcare laws and regulations, (18) adverse
events related to our products or product quality issues that could
require us to recall products and impact our sales, and (19) 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, 2010. 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://www.ccfa.org/info/about/crohns 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)
(4)
http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 212 867 1768 flazar@lazarpartners.com
dcarey@lazarpartners.com
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