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Given Imaging Announces PillCam(R) COLON Approval in Israel
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - February 20, 2008) - Given Imaging (NASDAQ : GIVN ), the global
leader in capsule endoscopy, today announced that Israel's Ministry of
Health, Health Technology and Infrastructure Administration has approved
PillCam® COLON, the first capsule endoscope to enable physicians to
visualize and evaluate diseases of the colon.
"We are pleased that the Israeli Health Ministry has approved PillCam
COLON. We will be working with gastroenterologists throughout the country
to educate them on this non-invasive alternative for imaging the colon,"
said Homi Shamir, president and CEO of Given Imaging.
"Colon Cancer is preventable if detected early, but less than 25% of
individuals in Israel over the age of 50 are screened for colon cancer.
PillCam COLON offers a non-invasive alternative for individuals who cannot
or do not wish to undergo colonoscopy and presents an opportunity to
increase adherence to colorectal cancer screening guidelines and save
lives," said Dr. Rami Eliakim, Chair of Medicine and Director of the
Department of Gastroenterology at Rambam Medical Center, Haifa, Israel.
As reported in a recent meeting of the Israeli Gastroenterology Society, it
is estimated that approximately 75 percent of Israelis do not undergo the
recommended screening. Colorectal cancer accounts for 1,300 deaths in
Israel annually.
About PillCam COLON
PillCam COLON enables the physician to directly see the colon mucosa in its
natural state while not requiring sedation, intubation, insufflation,
hospitalization or radiation. The PillCam COLON is a smooth plastic capsule
that measures 11mm by 31mm and can be naturally ingested with a sip of
water. It has tiny video cameras at each end which capture 4 images per
second for up to 10 hours. PillCam COLON utilizes advanced optics
technology, similar to the technology found in the second generation
PillCam SB and ESO capsules, which produces enhanced resolution images and
include automatic light control and a wide field of view.
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 650,000 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.