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Given Imaging Announces Permanent Level I CPT(R) Code for PillCam ESO
| Source: Given Imaging
YOQNEAM, ISRAEL -- (MARKET WIRE) -- November 3, 2006 -- Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that the American Medical Association (AMA) and the Center for
Medicare and Medicaid Services (CMS) have assigned a permanent CPT code for
PillCam™ ESO Capsule Endoscopy, effective January 1, 2007. The permanent
code for PillCam ESO is CPT 91111 and the physician Medicare national
average global fee schedule is $705. For the professional fee only, the
Medicare national average fee is $50. For outpatient hospitals, the
Medicare national average payment falls into the APC of 141 with a payment
rate of $511. The establishment of a CPT code for PillCam ESO allows for a
uniform mechanism to process claims across all payers.
Homi Shamir, president and CEO of Given Imaging said, "Today's news is a
significant milestone for our company as we anticipate that having a code
in place will encourage both public and private payers to issue
reimbursement policies on PillCam ESO. Obtaining a formal CPT code will
help to facilitate broad use of PillCam ESO as a non-invasive alternative
to upper endoscopy for visualizing the esophagus."
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.