Study Confirms PillCam(R) COLON's Potential as a Complement to Colonoscopy to Increase Colo-Rectal Screenings
PillCam(R) COLON Shows Encouraging Results Compared to Traditional CRC Screening Methods
YOQNEAM, ISRAEL and SAN DIEGO, CA--(Marketwire - May 19, 2008) - Given Imaging Ltd.
(NASDAQ: GIVN) today announced the results of an eight-center European
study confirmed that PillCam® COLON demonstrates encouraging results for
detecting colo-rectal polyps compared to colonoscopy. The results were
presented at the Digestive Disease Week® (DDW) 2008 conference taking
place in San Diego. The prospective study was led by Jacques Deviere, M.D.,
Erasme Hospital in Brussels.
"The promise of PillCam COLON is increasing the number of colo-rectal
screenings, which remain disappointingly low in Europe. This
patient-friendly alternative could become a key tool in the effort to
reduce the more than 212,000 colo-rectal cancer (CRC) deaths annually in
Europe," said Prof. Deviere. "Patients who can't or are unwilling to
undergo a colonoscopy have a new way to be screened in a very easy,
painless way. If polyps or cancerous lesions are found, then the physician
can perform a subsequent procedure to remove the lesions. The initial data
on PillCam COLON is extremely promising and we look forward to additional
clinical information to determine how best to use this valuable diagnostic
tool."
The primary objective of the study was to assess the accuracy of PillCam
COLON in detecting polyps as compared to traditional colonoscopy. The
eight-center trial enrolled 320 patients, with a mean age of 59 years.
Prior to capsule ingestion, patients underwent a traditional colon prep
after a
one-day liquid diet. The procedure included prokinetic tablets and
additional small doses of laxatives. No sedation, intubation or
insufflation was required. After capsule endoscopy with PillCam COLON, an
independent physician performed traditional colonoscopy.
Capsule endoscopy with PillCam COLON showed sensitivity (the ability to
positively identify disease) of 66%, with specificity (the ability to avoid
a false positive) of 82% in identifying significant findings, with a
positive predictive value (the percent who test positive when confirmed to
have the condition) of 72% and a negative predictive value (the percent who
test negative who are confirmed not to have the condition) of 77%.
Significant findings were defined as at least one polyp larger or equal to
6 mm or 3 polyps of any size. For polyps larger or equal to 6 mm and 10
mm, capsule endoscopy showed sensitivity of 64% and 60% and specificity of
84% and 98% respectively.
About PillCam COLON
Capsule endoscopy with PillCam COLON enables the physician to directly see
the colon mucosa in its natural state while not requiring sedation,
intubation, insufflation or radiation. The PillCam COLON video capsule 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
together capture 4 images per second for up to 10 hours. The PillCam COLON
video capsule utilizes advanced optics technology, which have been
specially adapted with a wide lumen and high degree of compartmentalization
that characterizes colon physiology.
PillCam COLON received the CE Mark in Europe in October 2006 and is
available in select clinics across Europe. It also has been cleared in
Australia, Canada, Israel and parts of Latin America.
*PillCam COLON is not cleared for marketing or available for commercial
distribution in the USA.
About Digestive Disease Week
DDW is the largest international gathering of physicians, researchers and
academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy and
the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22,
2008, at the San Diego Convention Center, San Diego, CA. The meeting
showcases approximately 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. For more
information, visit www.ddw.org.
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. PillCam COLON has received a CE Mark,
but is not cleared for marketing or available for commercial distribution
in the USA. More than 700,000 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, Australia and Singapore. 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, 2007. 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