Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced the
presentation of new data underscoring PillCam® SB's role as the
gold standard for diagnosing small bowel diseases. Particularly
noteworthy were studies on its use in the diagnosis of Iron
Deficiency Anaemia (IDA) and celiac disease, as well as how it can
optimize healthcare system resources. The studies were presented at
the United European Gastroenterology Week, taking place in
Amsterdam from October 20-24, 2012. Given Imaging is exhibiting at
booth #56 from Oct 22-24.
"PillCam SB capsule endoscopy is well accepted as the most
patient-friendly way to visualize and monitor diseases affecting
the small bowel mucosa," said Christophe Cellier, MD, Hôpital
Européen Georges Pompidou, Dept. de Gastroentérologie, Paris,
France. "The data presented this year at UEG Week expands upon our
existing knowledge by showing its value in the diagnosis and
monitoring of additional conditions including IDA and celiac
disease."
Key data showing the long-term value of PillCam SB in GI
bleeding, Iron Deficiency Anaemia (IDA) and refractory celiac
disease include:
- What is the Importance of Capsule Endoscopy in
Obscure Gastrointestinal Bleeding and Its Value in Predicting
Bleeding in the Long-Term? (P1453). Asli Ormeci, MD, Istanbul
University Istanbul Medical Faculty-Gastroenterohepatology,
Istanbul, Turkey, and colleagues presented data from a 36-month
study showing that the sensitivity and specificity of capsule
endoscopy in predicting re-bleeding was 100% and 93% respectively.
The authors concluded that the data show PillCam SB's long-term
value in OGIB.
- Diagnostic Yield of Small Bowel Capsule
Endoscopy in Iron Deficiency Anaemia Compared to Obscure
Bleeding (P1550). Based on a
retrospective analysis of more than 800 patients who had prior
inconclusive upper and lower GI endoscopy, Myriam Knieper, MD,
Hanseklinikum Gastroenterology, Stralsund, Germany, and colleagues
found that capsule endoscopy had a relevant diagnostic yield when
used for IDA. The investigators concluded that small bowel capsule
endoscopy could be helpful in diagnosing unexplained IDA.
- Diagnostic Yield of Capsule Endoscopy in
Refractory Celiac Disease (P0530). Maximilien Barret, MD,
Christophe Cellier, MD, Hôpital Européen Georges Pompidou, Dept. de
Gastroentérologie, Paris, France, and colleagues found concordance
of capsule endoscopy with histology which could help to predict
refractory celiac disease (CD). They concluded that capsule
endoscopy may play a key role in the diagnostic work-up of patients
with symptomatic CD and follow-up of non-responsive CD.
Additional data showing PillCam SB's economic value in an
outpatient setting, as well as the benefit that standardized
training has on increasing diagnostic skills include:
- Diagnostic Yield and Safety of Small Bowel
Capsule Endoscopy in Clinical Practice: Prospective Data from a
Regional Registry (P206). Marco Soncini, MD, Sofar Ao San
Carlo Borromeo, Milan, Italy, and colleagues presented data from a
regional registry from 32 centers. The study found that, through
shifting from an inpatient to an outpatient procedure, which
provided comparable clinical results in both settings, the use of
small bowel capsule endoscopy helped shorten the waiting list and
thus ensured a substantial sparing of resources.
- Small Bowel Capsule Endoscopy: Improvement of
Diagnostic Skills After Basic Hands-On Training Courses
(P769). Since capsule endoscopy is the gold-standard in the
evaluation of the small bowel, Olaf Humbla, MD, Bethesda
Krankenhaus Bergedorf Klinik für Innere Medizin, Hamburg, Germany,
and colleagues evaluated the need and impact of formal basic
courses, and found that training with hands-on demonstrations
significantly improves diagnostic skills related to correct
diagnosis, thus further enhancing the relevance of small bowel
capsule endoscopy.
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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