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National Heritage Insurance Company Revises PillCam(R) SB Guidelines for California Medicare Patients
Upper Endoscopy No Longer Necessary Prior to Capsule Endoscopy
| Source: Given Imaging Ltd.
YOQNEAM, ISRAEL -- (MARKET WIRE) -- May 15, 2007 -- Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that the National Heritage Insurance Company (NHIC), California's
Medicare Part B carrier, has revised its existing coverage policy for small
bowel capsule endoscopy so that patients will no longer be required to
undergo an upper endoscopy (EGD) prior to PillCam SB. NHIC serves
approximately 3 million Medicare beneficiaries in California.
NIHC's revised policy states that PillCam SB is now considered an
appropriate diagnostic following a negative colonoscopy to evaluate
patients with suspected, but undiagnosed Crohn's disease. Further policy
revisions include the use of PillCam SB in the diagnosis of iron deficiency
anemia (IDA). These amendments now coincide with policy changes made in
2006 by NHIC of New England which services an additional 1 million Medicare
beneficiaries in Massachusetts, Maine, New Hampshire and Vermont.
"Medicare administrators around the country continue to recognize the
ability to effectively detect and diagnose diseases of the small intestine
using capsule endoscopy," said Dr. C. Gregory Albers, medical director of
gastrointestinal diagnostic services the H.H. Chao Comprehensive Digestive
Disease Center at the University of California, Irvine Medical Center. "We
expect that this procedure will benefit more patients by eliminating the
need for a prior upper endoscopy."
The updated guidelines are effective immediately. Physicians reporting
claims for reimbursement of capsule endoscopy of the small bowel should use
CPT code 91110. For more information visit http://www.medicarenhic.com/
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 60 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 500,000 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) 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, 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.