Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced that
numerous studies confirming the value of Given Imaging's portfolio
of GI diagnostic and monitoring products will be presented at the
upcoming Digestive Disease Week (DDW). DDW will take place May 18 –
21, 2013, at the Orange County Convention Center, Orlando,
FL. Given Imaging will be exhibiting at booth #1059 throughout
the conference.
"DDW is an opportunity to showcase the clinical utility of our
entire product portfolio in diverse disease state areas including
Crohn's disease, GERD, GI dysmotility, OGIB, colorectal cancer and
achalasia," said Homi Shamir, President and Chief Executive
Officer, Given Imaging. "In conjunction with DDW, we are also
excited to celebrate that more than two million PillCam capsules
have been used in patients around the world. This important
milestone showcases the tremendous influence this product has for
detecting and monitoring conditions of the GI tract."
More than 140 studies presented at DDW will feature data on
Given Imaging's leading GI diagnostic product portfolio including
PillCam® SB, PillCam® COLON 2*, PillCam® ESO, Bravo® pH monitoring,
Digitrapper® pH-z monitoring, ManoScan® high resolution manometry
and the SmartPill® motility monitoring system. All data
presented at DDW will be embargoed until the time of
presentation. Important poster and podium presentations
include:
- Poster presentation Sa1323, Is the
Chicago Classification for Esophageal Motility Disorders Useful to
Predict Symptom Severity?, on Saturday, May 18th from 8:00
am - 5:00 pm
- Poster presentation Sa2034, Development of New
Parameters to Evaluate Anorectal Function Using High-Definition
Anorectal Manometry (HDM). the Anal Contractile Integrated (Aci),
the Post Squeeze Pressure (Psp), the Anal Integrated Relaxation
Pressure (Airp), and the Sliding Velocity in the Anal Canal
(Svac), on Saturday, May 18th from 8:00 am - 5:00 pm
- Podium presentation 689, Evaluation of the Second
Generation Colon Capsule Endoscopy (Cce-2) in Pediatric Ulcerative
Colitis (UC), on Monday, May 20th at 10:00 am
- Podium presentation 703, Prospective Trial of PillCam
Colon Capsule (CCE) vs CT-Colonography (CTC) in the Evaluation of
Patients With Incomplete Conventional Colonoscopy (CC): an Interim
Analysis, on Monday, May 20th at 10:30 am
- Poster presentation Mo2092, Wireless Motility Capsule
Alters Diagnosis and Affects Clinical Management in Patients With
Suspected Gastrointestinal Dysmotility, on Monday, May
20th from 8:00 am – 5:00 pm
- Podium presentation 907, Accuracy of PillCam COLON 2
for Detecting Subjects With Adenomas Greater Than or Equal To 6
mm, on Tuesday, May 21st at 8:45 am
- Poster presentation Tu1301, 8-Hour CE Versus 12-Hour CE
in a Cohort of Hospitalized Patients Undergoing CE for Suspected
Small Bowel Disorders, on Tuesday, May 21st from 8:00 am –
5:00 pm
- Poster presentation Tu1781, Description of Findings in
Esophageal Impedance -pH Monitoring in Patients With
Extraesophageal Symtomps and Suspected GERD in Hospital San Ignacio
Bogota A Hani, L Galindo, R Cañadas, R Rincón, A Rodríguez, R
Vargas, Y Suarez, G Guzmán, M Herrán, M Hernández, A
Leguizamo, J Alvarado, on Tuesday, May 21st from 8:00 am –
5:00 pm
Given Imaging will be exhibiting at booth #1059 throughout DDW
and will have information available about the Company's entire
product portfolio, including the latest information on product and
software advancements. At the booth, the Company will also be
highlighting the milestone of more than two million uses of PillCam
capsules in patients worldwide. Given Imaging representatives
will also demonstrate the new Bravo pH monitoring recorder.
*PillCam® COLON has received a CE Mark, but is pending 510K FDA
clearance and is not cleared for marketing or available for
commercial distribution in the U.S.A., Japan and certain other
countries.
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. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at
the Orange County Convention Center, Orlando, FL. The meeting
showcases more than 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
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
endoscopes 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, 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, 2012. 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.
CONTACT: For further information contact:
Chantal Beaudry/Martyna Gawrych
Lazar Partners Ltd.
cbeaudry@lazarpartners.com
mgawrych@lazarpartners.com
212-867-1762
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