YOQNEAM, ISRAEL--(Marketwire - July 15, 2009) - Given Imaging Ltd. (
NASDAQ:
GIVN) today
announced that results from a prospective multi-center study comparing the
performance of PillCam® COLON capsule endoscopy with optical colonoscopy
for the detection of colorectal polyps and cancer were published in the
July 16, 2009 issue of the New England Journal of Medicine. The study's
authors concluded that while this first-generation PillCam COLON's
sensitivity for detecting colonic lesions was lower than colonoscopy, colon
capsule endoscopy is a safe way to visualize the colon that obviates the
need for sedation, intubation or air insufflation.
The multi-center study enrolled 328 patients between January 2006 and July
2007 with known or suspected colonic disease. The primary endpoint of the
study was detection of colorectal polyps and cancer. As with colonoscopy,
PillCam COLON's sensitivity was significantly higher in patients with
adequate cleansing levels.
"The goal of our study was to evaluate the performance of capsule endoscopy
in detecting colonic polyps and colorectal cancer," said Jacques Devière,
M.D., Erasme Hospital in Brussels and lead investigator of the study. "The
data show that this first-generation PillCam COLON is safe and can
visualize the colon. We believe that with scheduled upgrades in capsule
technology, more efficient colon preparation and higher rates of adequate
colon cleansing among patients, PillCam COLON could be a promising new tool
to complement colonoscopy for detection of polyps and diagnosing colorectal
cancer."
Researchers computed sensitivity and specificity of capsule endoscopy for
polyps, advanced adenoma and cancer. The sensitivity for detecting large
polyps (greater than or equal to 6 mm) and advanced adenomas was 64% and
73%, respectively and specificity was 84% and 79%, respectively.
Douglas Rex, M.D., Professor of Medicine, Indiana University of Medicine,
Indianapolis, added, "Currently there are many individuals who are
unwilling or unable to undergo colonoscopy. This study suggests that with
technical improvements in the capsule and improvements in bowel cleansing,
the capsule could become a safe and effective method to detect colon polyps
in these patient populations."
Given Imaging received the CE Mark for the first-generation version of
PillCam COLON in 2006, which is now available commercially in Europe, Asia,
Latin America, Canada and Australia. PillCam COLON is not approved for use
in the U.S. Given Imaging is currently advancing a second-generation
PillCam COLON capsule through clinical trials in Israel.
"Given Imaging is committed to being the leader in developing innovative,
non-invasive GI diagnostic and screening tools. We support the GI
community's efforts to increase the rate of colorectal cancer screening and
are working closely with leading gastroenterologists to develop our
second-generation PillCam COLON with the goal of increasing its sensitivity
and simplifying the procedure for patients who are unwilling or unable to
undergo a colonoscopy procedure," said Homi Shamir, CEO and President of
Given Imaging Ltd. "We are encouraged by our progress and look forward to
initiating broad clinical trials later this year in Europe and the United
States, and to launching our second-generation PillCam COLON in Europe at
the Gastro 2009 conference this fall."
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. Despite
widespread public education efforts, colorectal cancer screening compliance
rates remain low, with just 50% of the eligible U.S. population undergoing
a colonoscopy.(4) About 147,000 people in the U.S. are diagnosed with
colorectal cancer annually, according to the National Cancer Institute.(5)
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
measuring 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 optical technology, similar
to the technology found in the second-generation PillCam SB and ESO
capsules, which produces enhanced resolution images and includes automatic
light control and a wide field of view. A second-generation PillCam COLON
is in development, with the goals being to increase sensitivity and to
simplify the procedure for patients and clinicians.
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 [PillCam COLON is not cleared for use in the USA] 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)
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 significant litigation, (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, (11) the impact of
global economic conditions, 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, 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://www.cdc.gov/cancer/colorectal/statistics/screening_rates.htm
(5) http://seer.cancer.gov/statfacts/html/colorect.html
Contact Information: For further information contact:
Fern Lazar
Lazar Partners Ltd.
917-362-2264
David Carey
Lazar Partners Ltd.
646-239-6231
Laura Yoshida
Lazar Partners Ltd.
646-387-5643
