Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced results
of two studies suggesting an increased role for capsule endoscopy
in detecting Crohn's lesions in the small bowel. The studies will
be presented at the United European Gastroenterology Week (UEGW),
Europe's largest gastroenterology conference, taking place in
Amsterdam from October 20-24, 2012. Given Imaging is exhibiting at
booth #56 from Oct 22-24.
"Capsule endoscopy for the detection of Crohn's disease in the
small bowel has been clinically validated by a substantial and
growing body of peer-reviewed research," said presenter Roberta
Pica, M.D., Department of Clinical Sciences, Gastroenterology Unit
at the Sapienza University of Rome. "As physicians, it's important
to gather as much information as possible about the structural
changes in the lining of the patient's small and large intestines
to determine an accurate diagnosis and proper course of treatment.
In this new study, early evidence shows that capsule endoscopy,
widely considered the gold standard in small bowel visualization,
is superior to magnetic resonance enterography (MRE) as a reliable
tool to evaluate the type and extent of mucosal lesions associated
with small bowel Crohn's disease. This information can lead to a
more precise course of treatment with the goal to improve patient
outcomes."
Dr. Pica and colleagues presented the results of a prospective
study (P1414) comparing use of wireless capsule endoscopy (WCE) to
magnetic resonance enterography (MRE) in the small bowel of 16
consecutive patients with confirmed or suspected Crohn's disease.
In nine of 10 patients (90%), WCE detected significant lesions as
indicated by the presence of erythema, aphthous, ulcers, fissures
or mucosal hemorrhages, with four patients showing lesions in both
the jejunum and ileum and five only of the terminal ileum. MRE was
less accurate than WCE, detecting inflammatory lesions in 11 of 15
patients (73%), with two patients showing lesions in both the
jejunum and ileum and nine in only the terminal ileum. In a group
of nine patients who were evaluated with both examinations, WCE
detected lesions in eight patients (90%), while MRE detected
lesions in six (67%). In addition, 2 patients had a false negative
on MRE and showed significant lesions in the terminal ileum with
capsule endoscopy, and capsule endoscopy was able to exclude a
false positive diagnosis of lymphoma suggested by MRE. The authors
concluded that both tools are complementary methods for diagnosing
small bowel Crohn's disease, noting that WCE represents a reliable
tool in the evaluation of mucosal lesions for the direct
visualization of the mucosal surface, while MRE enables physicians
to diagnose specific alterations of the bowel wall.
Separately, Efstathios Saprikis, M.D., 2nd Department of
Gastroenterology, Evangelismos Hospital, Athens, Greece, presented
a poster (P0203) showing that small bowel capsule endoscopy in
patients with established Crohn's disease is safe and associated
with a low percentage of capsule retention. When capsule retention
did occur, the majority of the cases were adequately managed with
conservative treatment. Dr. Saprikis and colleagues identified 301
patients who underwent ileocolonoscopy prior to small bowel capsule
endoscopy. Among the 301 eligible patients with established Crohn's
disease, capsule endoscopy identified signs of Crohn's disease in
the small bowel in 196 (65.1%). Capsule retention only occurred in
five patients (1.66%). These reported capsule retention rates are
in line with previously reported data as well as society guidelines
for CE use in patients with suspected Crohn's or established
Crohn's disease.
About United European Gastroenterology
UEG, or United European Gastroenterology, is a professional
non-profit organization combining all the leading European
societies concerned with digestive disease. Together, their member
societies represent over 22,000 specialists, working across
medicine, surgery, pediatrics, GI oncology and endoscopy. This
makes UEG the most comprehensive organisation of its kind in the
world, and a unique platform for collaboration and the exchange of
knowledge.
UEG's mission is continually to improve standards of care in
gastroenterology, and promote ever greater understanding of
digestive and liver disease -- among the public and medical experts
alike. As part of that work, it runs a number of education and
training courses facilitated by highly respected experts. UEG also
organizes UEG Week -- the largest and most prestigious meeting of
its kind in Europe. UEG Week has been running since 1992, in a
variety of major cities, and now attracts more than 14,000 people
from across the world. For more information, please visit
www.ueg.eu.
About PillCam® SB The PillCam®SB video
capsule is a minimally invasive procedure to visualize and monitor
lesions associated with inflammatory bowel disease (IBD), Crohn's
disease and obscure GI bleeding (OGIB). The PillCam 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 PillCam
patency capsule 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® capsule endoscope for the small bowel,
esophagus and colon. The company also offers industry-leading GI
functional diagnostic solutions including ManoScan™ high-resolution
manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z
impedance, and the SmartPill® GI monitoring systems. 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, Hong Kong and Brazil. 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. Such
forward-looking statements include statements relating to the
Company exploring strategic alternatives and considering possible
strategic transactions involving the Company. 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 ability of the Company to
reach agreement on any strategic alternative and/or to complete any
such alternative, as well as 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) quality
issues and adverse events related to our products, such as capsule
retention, aspiration and failure to attach or detach, bleeding or
perforation that could require us to recall products and impact our
sales and net income, 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, 2011. 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 to the
extent expressly required under applicable law, the Company
undertakes no obligation to release publicly any revisions to any
forward-looking statements, to report events or to report the
occurrence of unanticipated events.
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 1-212-867-1762 flazar@lazarpartners.com
dcarey@lazarpartners.com Israel Investor Contact: Nava Ladin
Gelbart Kahana Investor Relations +972-3-6074717
nava@gk-biz.com
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