Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced three new
studies underscoring the value of PillCam SB in detecting and
evaluating Crohn's lesions in the small bowel. The studies were
presented at the United European Gastroenterology Week (UEGW),
Europe's largest gastroenterology conference, being held in
Stockholm, Sweden from October 22nd through October 26th. Given
Imaging is exhibiting at booth A08:30 throughout the conference.
"Using capsule endoscopy with appropriate patients who have
clinically suspected Crohn's disease can help physicians reach a
definitive diagnosis sooner, which may lead to improved patient
management and symptom relief," said Ervin Toth, MD, Endoscopy
Unit, Skane University Hospital, Lund University, Malmö, Sweden.
"The results of our study suggest that physicians should consider
incorporating capsule endoscopy earlier into the diagnostic work-up
of patients with suspected Crohn's disease."
In a new study (abstract P1442) titled,
"Capsule Endoscopy is Superior to Magnetic Resonance Enterography
for Detection of Crohn's Lesions in the Small Bowel," researchers
from Skane University Hospital at Lund University in Malmö, Sweden,
retrospectively compared capsule endoscopy and MRE for diagnostic
utility in definitively diagnosing Crohn's disease among patients
in whom Crohn's was clinically suspected. Of the 115 patients
evaluated, 33 percent exhibited lesions consistent with Crohn's. In
more than half (52%, 17/33) of the patients definitively diagnosed
with Crohn's, their MRE findings were negative, and capsule
endoscopy revealed larger extension of Crohn's compared to MRE in
four additional patients. The study authors concluded that a large
proportion of mucosal lesions that could indicate the presence of
small bowel Crohn's disease are not detected by MRE. In addition,
using MRE alone to manage patients may lead to inadequate
therapeutic treatment strategies.
A second study (abstract P0121) titled,
"Role of capsule endoscopy in the evaluation of different segments
of the small bowel in Crohn's disease: Correlation of biomarkers,
endoscopy, and Lewis Score," Portuguese researchers from Hospital
Sao Joao Porto in Porto, Centro Hospitalar do Alto Ave in Guimaraes
and University of Porto in Porto evaluated the correlation of
biomarkers and endoscopy with the Lewis score (LS) in each third of
the small bowel, demarcated by transit time in 87 patients.
Researchers found that 28 percent of patients had high degree of
correlation in the first two thirds of the small bowel rating the
LS greater than 135. There were additional correlations found
between LS and biomarkers including sideropenia, total serum
protein, serum albumin and c-reactive protein levels and platelet
counts. In the third segment of the small bowel, investigators
detected significant correlations between LS and hemoglobin levels
and thrombocytosis in addition to other biomarkers involved in the
first two tertile segments. Researchers concluded that there is a
correlation among upper digestive tract disease, biomarkers and
endoscopic findings, underlining the importance of capsule
endoscopy in Crohn's disease.
A third study (abstract P0110) titled,
"Clinical outcome and management of small bowel video capsule
retention in a single-center 10-year experience of 2,409
procedures," concluded that capsule retention is a rare
complication and in most cases can be managed electively with
non-surgical intervention. Researchers at Skane University Hospital
of Lund University in Malmö, Sweden, reviewed the medical records
of 2,409 consecutive patients who had undergone capsule endoscopy
procedures between 2001 and 2011. One percent (25/2409) of patients
retained capsule, including 11 patients who had undergone previous
abdominal surgery. Emergency intervention was required in just four
cases, three of which were managed endoscopically and one of which
was managed surgically. Non-emergency cases were managed
endoscopically in eight cases and surgically in 7 cases. Three
capsules dislodged after steroid treatment and three cases resolved
without intervention.
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 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 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 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.
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 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) 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) 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) (4)
http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 1-212-867-1768 flazar@lazarpartners.com
dcarey@lazarpartners.com
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