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Given Imaging Announces German Public Health System to Initiate Reimbursement Process for PillCam(TM) SB
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - January 28, 2008) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that the German Gemeinsame Bundesausschuss (Joint Federal
Committee) declared that it will begin to evaluate capsule endoscopy for
out-patient coverage under the German national insurance program which
covers most of Germany's 82 million citizens. About 10 percent of German
citizens currently have coverage for PillCam™ SB through private health
insurers.
"We are pleased that the German public health system will evaluate PillCam
SB so that all German citizens can benefit from a diagnostic tool proven to
be an effective and patient-friendly way to detect small bowel diseases.
We anticipate a decision in the next 12 to 18 months," said Homi Shamir,
president and CEO of Given Imaging. "Today's news is yet another example of
the progress we are making in achieving reimbursement around the world. In
addition to previously announced decisions in major markets including the
U.S., Japan and the U.K, we also expect to receive a monetary code for
reimbursement in France in the first half of 2008, as well as additional
reimbursement polices for PillCam SB and PillCam ESO in the U.S and other
countries this year."
Within two to three months, the Joint Federal Committee is expected to
solicit input from medical experts, scientific societies, professional
associations and patient organizations. Thereafter the Committee will
deliberate on reimbursement. Assuming a positive outcome, the Committee
would then recommend coding and initiate the monetary valuation for the
procedure.
Given Imaging European headquarters have been based in Hamburg, Germany
since 2001.
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® 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® 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™ 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, and is pending clearance with the
United States Food and Drug Administration. More than 600,000 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 and Australia. For more information, visit
http://www.givenimaging.com.
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) satisfactory results of clinical trials with PillCam Colon
(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 future litigation, including patent
litigation with Olympus Corporation, (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, 2006. 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.