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Given Imaging Announces Progress With Second-Generation PillCam(R) COLON
Encouraging Results From the First Trial in Israel; CE Mark Obtained
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - September 14, 2009) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced encouraging results from a trial that validated new features of
the company's second-generation PillCam® Colon video capsule and system.
The Company also announced that it has obtained the CE mark for the sale of
PillCam COLON 2 in Europe.
Conducted by clinicians at five hospitals in Israel, the study evaluated
the performance of PillCam COLON 2 in 98 patients who had risk or warning
symptoms of colon pathology. Like other PillCam capsules in Given
Imaging's suite of products, PillCam COLON 2 does not require the use of
sedation, intubation or air insufflation during the procedure. The Company
intends to reveal PillCam COLON 2 in Europe at the Gastro 2009 conference
this fall at which time it will disclose additional details, including
product specifications and software enhancements.
"The main purpose of the trial was to evaluate the performance of new
technologies embedded in the new capsule and PillCam platform. The results
of this feasibility trial confirm the functionality of the system and give
us increased confidence about the potential of PillCam COLON 2 as a useful
tool for visualizing pathology in the colon. Despite statistical
limitations resulting from the size of the trial and the relatively low
prevalence of polyps, we are very pleased with the high degree of
consistency in the sensitivity and specificity of the data, both of which
were high and balanced," said Homi Shamir, CEO and President of Given
Imaging Ltd. "We are now initiating additional multicenter clinical
trials in Europe and Israel and intend to complete these trials over the
next few months. Subsequently, we will begin a phased roll out of PillCam
COLON 2 in Europe and a few other countries outside of the U.S. in 2010. On
a parallel track, we have initiated pre-registration studies in the United
States with leading key opinion leaders to prepare for a subsequent FDA
pivotal trial."
PillCam COLON currently is not available for sale in the United States.
About Colorectal Polyps
There are two common types of colorectal polyps: adenomatous, which can
develop into cancer, and hyperplastic, which are rarely more than 5 mm in
size and are rarely cancerous.(1) For adenomas, the potential for
malignancy is related to polyp size.(2) Larger polyps are more likely to
develop into cancer, and polyps that are over 2 cm in size may potentially
contain cancer.(3)
About Colon Cancer
Colon cancer involves the large intestine (colon), the lower part of the
digestive tract, while rectal cancer involves the last 6 inches of the
colon. Together, they're often referred to as colorectal cancers. Colon and
rectal cancers begin in the digestive tract and occur when cells that line
the colon or the rectum become abnormal and grow out of control. About
147,000 people in the U.S. are diagnosed with colorectal cancer annually,
according to the National Cancer Institute.(4)
About PillCam COLON
PillCam COLON enables the physician to directly see the colon mucosa in its
natural state while not requiring sedation, intubation, air insufflation,
hospitalization or radiation. PillCam COLON is a smooth plastic capsule
which can be naturally ingested with a sip of water. It utilizes advanced
optical technology with tiny video cameras at each end, which produces
enhanced resolution images and includes automatic light control and a wide
field of view.
About Given Imaging Ltd.
Given Imaging has advanced gastrointestinal diagnosis by developing
innovative, patient-friendly tools based on its PillCam® Platform.
PillCam capsule endoscopy provides physicians with natural images of the
small intestine via PillCam® SB, the esophagus through PillCam® ESO,
and the colon with PillCam® COLON [PillCam COLON is not cleared for use
in the USA]. The PillCam capsules are miniature video cameras that patients
ingest. Given Imaging's other capsule products include Agile™ patency
capsule, to verify intestinal patency, and Bravo®, the only wireless,
catheter-free, 48-hour pH test commercially available for pH testing to
assess gastroesophageal reflux disease (GERD). Given Imaging's products use
cutting-edge, wireless technology and advanced software to enable
gastroenterologists to better diagnose disease of the esophagus, small
bowel and colon and more accurately treat patients. All Given Imaging
products allow patients to maintain normal activities. Since 2001, more
than one million PillCam® video capsules have helped physicians evaluate
patients for GI disorders. Given Imaging's headquarters, manufacturing and
R&D facilities are located in Yoqneam, Israel, with operating subsidiaries
in the United States, Germany, France, Japan, Australia and Singapore. For
more information, please visit http://www.givenimaging.com.
Forward-Looking Statements
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) our ability to develop and bring to market new products, (2)
the results of clinical trials with our products, (3) our ability to
receive regulatory clearance or approval to market our products or changes
in regulatory environment, (4) our success in implementing our sales,
marketing and manufacturing plans, (5) protection and validity of patents
and other intellectual property rights, (6) the impact of currency exchange
rates, (7) the effect of competition by other companies, (8) the outcome of
significant litigation, (9) our ability to obtain reimbursement for our
product from government and commercial payors, (10) quarterly variations in
operating results, (11) the possibility of armed conflict or civil or
military unrest in Israel, (12) the impact of global economic conditions,
and (13) 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, 2008. 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.
(1) http://www.mayoclinic.com/health/colon-polyps/DS00511/DSECTION=causes
(2) http://emedicine.medscape.com/article/367452-overview
(3) http://www.asge.org/PatientInfoIndex.aspx?id=396
(4) http://seer.cancer.gov/statfacts/html/colorect.html