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Given Imaging Receives NSE Letter From the U.S. Food and Drug Administration Regarding Its Application to Market PillCam(R) COLON
Company Accelerates Development of Next Generation PillCam COLON Capsule
| Quelle: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - February 18, 2008) - Given Imaging Ltd. (NASDAQ : GIVN ), the
global leader in capsule endoscopy, today announced that the U.S. Food and
Drug Administration (FDA) has sent the company a not substantially
equivalent (NSE) letter regarding its 510(k) application to market
PillCam® COLON in the United States.
"While we are disappointed by the FDA's decision we are evaluating our
options to bring PillCam COLON to the U.S. market as quickly as possible,"
said Homi Shamir, president and CEO of Given Imaging. "We recently
launched PillCam COLON in Europe and in other countries, and we are working
closely with leading GI clinicians to determine its optimal role in patient
care. On a parallel track and consistent with our commitment to
innovation, we are accelerating development of a next generation colon
capsule," added Mr. Shamir.
The Company does not expect this decision to have a material impact on 2008
revenues as PillCam COLON capsule sales in the U.S. were not projected to
be significant in 2008.
As previously announced, the Company will publish its audited financial
results for the fourth quarter and full year 2007, and provide 2008
financial guidance following the close of trading on Wednesday, February
20, 2008. The company will host a conference call in Hebrew at 7:00am ET
and in English at 9:00am ET on Thursday, February 21 to discuss these
matters.
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. 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. Given Imaging's largest
shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). 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) our ability to obtain
reimbursement for our product from government and commercial 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.