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64 Million French Citizens Now Have Reimbursed Access To Non-Invasive Tool For Diagnosing Small Bowel Disease
Given Imaging Ltd.
(NASDAQ: GIVN) today announced that the French Ministry of Health has
concluded the reimbursement process for PillCam(R) SB and set a
pricing level of 418EUR without VAT. The decision was published in
the Journal Officiel on November 21, 2008. Now all of France's 64
million citizens will have reimbursable access to Pillcam SB for the
following indications:
-- Unexplained obscure and occult GI bleeding after negative colonoscopy
and EGD (upper endoscopy)
-- Iron deficiency anemia after negative colonoscopy and EGD
-- Confirmation of suspected small bowel Crohn's disease following
negative small bowel follow through and colonoscopy
"Clinical data confirms that capsule endoscopy is the gold standard
for diagnosing small bowel disorders in a non-invasive,
patient-friendly manner. With this decision, all French citizens
will now have access to an effective diagnostic tool that can lead to
improved management and outcome of intestinal diseases," said
Professor Gerard Gay from University Hospital of Nancy.
"This is an important milestone for Given Imaging and we are very
pleased that the French Ministry of Health has recognized the
importance of capsule endoscopy for the small bowel.
Gastroenterologists throughout France will now be able to offer their
patients PillCam SB to diagnose and treat gastrointestinal disease,"
said Homi Shamir, president and CEO of Given Imaging. "Today,
approximately 560 million individuals worldwide including 235 million
Europeans have reimbursed access to PillCam SB. We are working
diligently to advance this process and we expect additional
reimbursement decisions from other major European health ministries
in the future."
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing,
producing and marketing innovative, patient-friendly products for
detecting gastrointestinal disorders. The company's technology
platform is the PillCam(R) Platform, featuring the PillCam video
capsule, a disposable, miniature video camera contained in a capsule,
which is ingested by the patient, a sensor array, data recorder and
RAPID(R) software. Given Imaging has a number of available capsules:
the PillCam SB video capsule to visualize the entire small intestine
which is currently marketed in the United States and in more than 60
other countries; the PillCam ESO video capsule to visualize the
esophagus; the Agile(TM) patency capsule to determine the free
passage of the PillCam capsule in the GI tract and the PillCam COLON
video capsule to visualize the colon that has been cleared for
marketing in the European Union. PillCam COLON has received a CE
Mark, but is not cleared for marketing or available for commercial
distribution in the USA. More than 820,000 patients worldwide have
benefited from the PillCam capsule endoscopy procedure. Given
Imaging's headquarters, manufacturing and R&D facilities are located
in Yoqneam, Israel. It has operating subsidiary companies in the
United States, Germany, France, Japan, Australia and Singapore. Given
Imaging's largest shareholders include Elron Electronic Industries
(NASDAQ: ELRN) (TELAVIV: ELRN). For more information, visit
http://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 receive regulatory
clearance or approval to market our products or changes in regulatory
environment, (3) our success in implementing our sales, marketing and
manufacturing plans, (4) protection and validity of patents and other
intellectual property rights, (5) the impact of currency exchange
rates, (6) the effect of competition by other companies, (7) the
outcome of significant litigation, (8) our ability to obtain
reimbursement for our product from government and commercial payors,
(9) quarterly variations in operating results, (10) the possibility
of armed conflict or civil or military unrest in Israel, and (11)
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,
2007. 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.
Given Imaging Ltd
64 de milioane francezã ramburseazã Cetãþenii au acum acces la non-invazive Instrumentul pentru diagnosticarea bolilor intestinului subþire - 64 Million French Citizens Now Have Reimbursed Access To Non-Invasive Tool For Diagnosing Small Bowel Disease - articole medicale engleza - startsanatate