Given Imaging Announces New Capsule Endoscopy Reimbursement Policies for PillCam ESO and PillCam SB
Florida and Connecticut Medicare Patients Now Have Access to PillCam(TM) ESO
YOQNEAM, ISRAEL -- (MARKET WIRE) -- October 31, 2006 -- Given Imaging Ltd. (NASDAQ: GIVN) today
announced new capsule endoscopy reimbursement policies for PillCam™ ESO
and PillCam™ SB.
Esophageal Capsule Endoscopy
First Coast Service Options, Inc., administrator of Florida and Connecticut
Medicare, has updated its capsule endoscopy guidelines becoming the first
third-party payor to designate PillCam ESO to be medically reasonable and
necessary as a diagnostic tool for patients who are unable to undergo
conventional endoscopy or are diagnosed with portal hypertension and
require immediate evaluation of esophageal varices. The updated guidelines
are effective October 30, 2006. First Coast Service Options provides
benefits to over 3 million beneficiaries. For more information visit the
Centers for Medicare and Medicaid website at:
http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=13831&lcd_version=8&show=all#19.
Mark Gilreath, senior vice president of global marketing at Given Imaging,
said, "We applaud First Coast Service for their commitment to delivering
the best care to their patients and are pleased that they recognized the
value that PillCam ESO holds for helping those patients who cannot undergo
conventional endoscopy or are at risk for varices. We anticipate that
other payors will recognize this value to help them deliver the best
patient care."
Small Bowel Capsule Endoscopy
Spain's National Health Service has included capsule endoscopy for the
small bowel in its portfolio of health services. Effective immediately,
individuals with symptoms of persistent obscure gastrointestinal bleeding
of presumed small bowel origin following negative upper and lower
endoscopies may undergo the PillCam SB procedure at hospitals and clinics
that offer it.
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.
Contact Information: For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-(866) GIVEN-IR
Email Contact/
Email Contact