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Given Imaging Announces Aetna to Cover Capsule Endoscopy of the Esophagus
First Private Insurance Payer to Cover Procedure for Esophageal Varices
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - November 19, 2007) - Given Imaging Ltd. (NASDAQ : GIVN ), the
global leader in capsule endoscopy, today announced that Aetna, the
third-largest U.S. health insurer, has updated its capsule endoscopy policy
effective November 9, 2007. Under the new guidelines, Aetna will now cover
cirrhotic patients for the screening and surveillance of esophageal varices
using capsule endoscopy of the esophagus. Aetna currently serves 16.6
million medical members. The addition of Aetna's coverage policy now brings
the total number of people in the U.S. that have reimbursable access to
PillCam® ESO to approximately 30 million.
"We commend Aetna for recognizing PillCam ESO and its role in the
evaluation of esophageal varices in cirrhotic patients," said John M.
Vierling, M.D., Baylor College of Medicine. "We hope that additional payers
will soon recognize the value of this non-invasive procedure to identify
patients with varices so that we can use proven prophylatic therapies to
reduce the risk of bleeding."
Varices are varicose veins that occur in the esophagus as a result of
portal hypertension, which is a complication of cirrhosis. The increased
pressure within esophageal varices makes them susceptible to rupture and
bleeding. Approximately 360 of every 100,000 Americans have cirrhosis, and
gastroesophageal varices are present in 40-60% of these patients.
Physicians seeking additional information can access the updated policy at
http://www.aetna.com/cpb/medical/data/500_599/0588.html or can contact
Given Imaging's Reimbursement Help Line at 1-888-389-5200.
About PillCam ESO
Cleared by the U.S. Food and Drug Administration in November 2004 to
visualize the esophagus in adult patients in a patient-friendly way,
physicians can use PillCam ESO to aid in the detection of disorders such as
Barrett's esophagus, a potential precursor for esophageal cancer and
esophageal varices, which if left untreated, can result in fatal bleeding.
PillCam ESO contains imaging devices and light sources at both ends of the
capsule that capture up to 14 images per second, a total of 2,600 color
images, as it passes down the esophagus in a twenty-minute procedure.
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) the reimbursement policies for our
product from healthcare 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.