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Given Imaging Announces United Healthcare Expands Policy to Cover Celiac Disease
Trailblazer Health Enterprises Also Issues New Policy Covering Both PillCam SB as Well as PillCam ESO for Patients With Portal Hypertension
| Source: Given Imaging
YOQNEAM, ISRAEL -- (MARKET WIRE) -- February 12, 2007 -- Given Imaging Ltd. (NASDAQ : GIVN ) today
announced one revised and one new capsule endoscopy reimbursement policy.
United Healthcare revised its small bowel capsule endoscopy coverage policy
to include suspected celiac disease patients with a positive serology, but
a normal endoscopic biopsy, and patients with known celiac disease and
suspected malignancy. United Healthcare serves more than 18 million
customers.
"Celiac disease is a serious life-long intestinal disorder that affects one
out of every 133 Americans, most of whom have no idea that they have the
disease. Broader use of PillCam SB can enhance our ability to diagnose and
monitor more patients with celiac," said Peter H.R. Green, MD, Director of
The Celiac Disease Center at Columbia University.
TrailBlazer Health Enterprises, a Part B Medicare carrier serving more than
3.6 million individuals in Delaware, the District of Columbia, Maryland,
Texas and Virginia, issued a new policy covering capsule endoscopy of both
the small bowel, as well as the esophagus. TrailBlazer's small bowel
policy covers a variety of indications including celiac and Crohn's
disease. The TrailBlazer policy also states that esophageal capsule
endoscopy may be used to evaluate esophageal varices in patients with
portal hypertension as an alternative to upper GI endoscopy. Portal
hypertension is a major complication of liver cirrhosis and can lead to
variceal bleeding or death if not treated.
"Clinical studies have shown PillCam ESO is an accurate, noninvasive
alternative to upper endoscopy to detect esophageal varices without the
need for conscious sedation," said Dr. John M. Vierling M.D., Professor of
Medicine and Surgery, Director of Baylor Liver Health and Chief of
Hepatology at the Baylor College of Medicine in Houston, Texas and past
president of American Association for the Study of Liver Diseases (AASLD).
The payors that cover PillCam ESO for this designation serve more than 6.6
million members in the U.S.
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 three commercially 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 50 other countries; the PillCam ESO
video capsule to visualize the esophagus; and the Agile™ patency capsule
to determine the free passage of the PillCam capsule in the GI tract. The
PillCam COLON video capsule to visualize the colon has been cleared for
marketing in the European Union, and multi-center clinical trials are
underway in Europe and the U.S. A capsule to visualize the stomach is under
development. More than 400,000 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
direct sales and marketing operations in the United States, Germany and
France, and local offices in Japan, Spain 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) 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) the reimbursement policies for our
product from healthcare payors, (9) quarterly variations in operating
results, (10) the impact of the newly adopted SFAS 123R for expensing
option-based payments, (11) the possibility of armed conflict or civil or
military unrest in Israel, and (12) 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, 2005. 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.