New Survey Results Show That the Majority of Surveyed Crohn's

New Survey Results Show That the Majority of Surveyed Crohn's
Patients Prefer a Monitoring Method That Does Not Involve Sedation or
Radiation 
72% of Surveyed Crohn's Patients Are Concerned About Long-Term
Effects of Radiation in Monitoring; Only 19% of Those Surveyed
Monitor Their Condition Regardless of Symptoms 
YOQNEAM, ISRAEL -- (Marketwire) -- 12/04/12 --  Given Imaging Ltd.
(NASDAQ: GIVN), a world leader in GI medical devices, and maker of
PillCam(R) capsule endoscopy, today announced the results of Crohn's
Voices, an online survey of Crohn's patients about their
understanding of their condition, their approach to managing their
condition with their physician, and what matters most to them in a
clinical test of disease activity. Key findings from the Crohn's
Voices survey show that 75% of patients consider the most important
test-related aspect for Crohn's repeat evaluation methods to be for
physicians to be able to have a better view of their GI tract. They
also shared that they have a significant amount of concern about the
use of monitoring methods that include sedation and radiation. The
survey also showed that only 19% of patients undergo a regular
evaluation of their clinical status, regardless of their Crohn's
symptoms. 
"The Crohn's Voices survey provides useful insights on Crohn's
patients' understanding of their condition, and about the need for
meaningful conversations between patients and doctors about the value
of regular monitoring of their disease activity," said Joel Rosh, MD,
Goryeb Children's Hospital, Morristown, New Jersey. "Physicians and
patients also need to discuss what the options for direct
visualization of their GI tract are, as the surveyed patients
indicate a concern about the risks of sedation and radiation." 
Crohn's disease is a chronic and progressive form of inflammatory
bowel disease that can affect any area of the GI tract, with lifelong
consequences. In 75% of Crohn's cases, patients have lesions in the
small bowel(1). However, the small bowel has traditionally been a
difficult part of the GI tract for physicians to visualize, but it is
an essential part of the anatomy for successfully evaluating and
monitoring the progression of Crohn's. 
The ongoing assessment, or monitoring, of disease progression in CD
patients, even when symptoms are absent, is considered to be key to
the management of this lifelong condition. Crohn's disease can
progress even without changes in symptoms, and many Crohn's patients
can have active disease without exhibiting symptoms for extended
periods of time. 
Crohn's Voices: Patient Awareness on the Value of Monitoring 
 While
monitoring the condition even in the absence of symptoms is very
important, the Crohn's Voices survey also indicates that 45% of
respondents only evaluate or monitor their condition, either through
observation or testing, when their symptoms change. In fact, only 19%
of Crohn's patients surveyed said that they make a point of
undergoing routine monitoring tests regardless of symptoms. However,
three times more respondents, or 64%, said that they would be more
likely to have regular monitoring if they knew that their condition
could worsen without symptom changes. 
Radiation and Other Concerns in Crohn's Monitoring
 Imaging
techniques that involve diagnostic radiation are commonly used in
assessing Crohn's disease activity, but they have the potential to be
harmful to patients' health, with published data showing that
individuals have a 1 in 1000 risk of developing cancer from the
radiation exposure associated with a CT scan(2). 
The Crohn's Voices survey asked patients their thoughts about the
various available methods of assessing their condition. The results
indicated that 62% of respondents are moderately to strongly
concerned about radiation from some Crohn's monitoring methods, and
72% are concerned about long-term effects of radiation in monitoring.
Additionally, 50% of those surveyed indicated that they are
moderately to strongly concerned about having to be accompanied to
their monitoring procedures, and 50% are moderately to strongly
concerned about having to be sedated for some of these procedures. 
What Patients Want in a Monitoring Method
 The Crohn's Voices survey
also aimed to determine what patients prefer in a method of
evaluating their clinical status. In this regard, 75% of respondents
felt strongly that they preferred their doctor to use a tool that
provides a better view of the GI tract.  
In addition, a large majority, 75%, of those surveyed would strongly
prefer a monitoring method that did not require them to undergo
sedation or receive radiation, and allowed them the freedom to leave
their physician's office during the procedure. 
"Traditionally, most of the small bowel could only be visualized with
X-rays, which can miss important diagnostic details and expose
patients to potentially harmful levels of radiation. Capsule
endoscopy (CE) technology, such as PillCam SB, provides a
non-invasive way to get a better view of the lining of the GI tract,
without radiation, making it a convenient and accurate tool for
monitoring disease activity and response to therapy," said Dr. Rosh.
"Patients and physicians should have an open dialogue about the
importance of regular monitoring and all the available methods." 
About the Crohn's Voices Survey
 Crohn's Voices is an unblinded
Crohn's patient survey, sponsored by Given Imaging, that was
conducted by Research Now, an independent survey company. The survey,
conducted online in November 2012, asked 102 individuals in the
United States living with Crohn's disease about their understanding
of their condition, their approach to monitoring, and what matters
most to them in a monitoring method. The survey participants received
nominal compensation in the form of points towards purchase for their
participation. 
About PillCam(R) SB 
 The PillCam(R) SB capsule endoscope 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. PillCam SB was cleared by the
U.S. Food and Drug Administration in 2001. PillCam capsule endoscopy
has been clinically validated by more than 1,800 peer-reviewed
studies. It is an accurate, patient-friendly tool used in patients
two years and older by physicians to visualize the GI tract. PillCam
SB is the gold standard in small bowel evaluation. 
The risks of PillCam(R) 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(R) capsule endoscope for the small bowel, esophagus and
colon. The company also offers industry-leading GI functional
diagnostic solutions including ManoScan(TM) high-resolution
manometry, Bravo(R) capsule-based pH monitoring, Digitrapper(R) pH-Z
impedance, and the SmartPill(R) 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. 
(1) Engstrom PF, Goosenberg EB, Diagnosis and Management of Bowel
Diseases. Caddo, OK: Professional Communications Publisher; 1999. 
(2) ECRI Institute CT Scanning Systems Infographic White Paper 2012
https://www.ecri.org/Forms/Pages/CT-Scanning-Systems-Infographic-White-Paper.aspx 
For further information contact:
Chantal Beaudry/Karen Famighetti
Lazar Partners Ltd.
cbeaudry@lazarpartners.com
kfamighetti@lazarpartners.com
212-867-1762  
Israel Investor Contact:
Nava Ladin
Gelbart Kahana Investor Relations
+972-3-6074717
nava@gk-biz.com 
 
 
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