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Results of First PillCam(TM) COLON Studies Published in Endoscopy
| Source: Given Imaging
YOQNEAM, ISRAEL -- (MARKET WIRE) -- October 20, 2006 -- Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that the results of the first PillCam™ COLON clinical studies
were published in the October Issue of Endoscopy, the official journal of
The European Society of Gastrointestinal Endoscopy. Conducted
independently by the Rambam Medical Center, Hillel-Yaffe Medical Center and
Bikur Holim Hospital in Israel and Erasme University Hospital in Belgium,
both studies determined PillCam COLON to be a promising new modality for
colonic evaluation.
Jacques Devière M.D., investigator on the COLON pilot study, professor of
medicine at Brussels Erasme University Hospital and president elect of the
European Society of Gastrointestinal Endoscopy, said, "While still early,
these data provide compelling evidence that PillCam COLON could be used as
one of the diagnostic tests used by doctors to visualize abnormalities of
the colon."
"The ideal method to visualize the colon should be noninvasive, convenient,
safe, well accepted by the target population, show high diagnostic accuracy
and be cost-effective," said Rami Eliakim M.D., lead investigator of the
Israeli multi-center study and chief of gastroenterology at Rambam Medical
Center in Haifa, Israel. "If further study results confirm the recent
data, PillCam COLON could represent a patient-friendly method for
physicians to visualize the colon that could potentially lead to
significantly wider patient compliance with guidelines."
About the Studies
Evaluation of the PillCam COLON capsule in the detection of colonic
pathology; results of the first multi-center, prospective, comparative
study
A total of 91 individuals were enrolled in three Israeli centers; the
results were evaluable in 84 cases. The patients were all scheduled for
traditional colonoscopies later in the day.
Polyps of any size were found in 45 patients by either of the screening
methods. PillCam COLON identified 76% (n=34) compared to 80% (n=36) by
colonoscopy. Out of the 84 patients, approximately 24% (n=20) had
significant findings, defined as at least one polyp measuring 6 mm or three
or more polyps of any size. Of these, PillCam COLON identified 14 (70%)
and colonoscopy 16 (80%). There were no adverse events reported except in
one patient who had severe abdominal pain immediately following
colonoscopy. The colonic preparation was well tolerated in all cases.
The initial 44 subjects enrolled in the study received a single oral
"booster" dose of sodium phosphate. The PillCam COLON capsule was excreted
within 10 hours in 70% of the patients and reached various parts of colon
in the other 30%. An additional dose of oral sodium phosphate was added to
the regimen of the final 46 subjects to improve the capsule excretion rate.
The PillCam COLON capsule in these patients was excreted within 10 hours in
78% of the patients and reached the rectosigmoid colon in the other 22%.
Study investigators concluded that further improvements in the procedure
will probably increase capsule examination completion and polyp detection
rates.
PillCam COLON capsule compared with colonoscopy for colorectal tumor
diagnosis: a prospective pilot study
Conducted by investigators at Erasme University Hospital in Belgium, this
single-center prospective pilot study compared PillCam COLON with
colonoscopy for colorectal tumor diagnosis. Of the 41 patients enrolled in
the study, 36 were analyzed.
PillCam COLON identified polyps of any size in 19 of 25 patients or 76% and
significant polyps, defined as at least one polyp measuring 6 mm or three
or more polyps of any size, in 10 out of 13 patients or 77%. Seven polyps
not captured during colonoscopy were also identified by PillCam COLON.
The overall sensitivity of PillCam COLON to detect polyps was 77% and
specificity was 70%. PillCam COLON was excreted within 10 hours in 84% of
the patients and reached various parts of colon in the other 16%. The
investigators concluded that PillCam COLON visualized the entire colon in
the majority of cases and provides encouraging sensitivity and negative
predictive values for the detection of significant lesions.
About PillCam COLON
PillCam COLON is the third video capsule to be developed and manufactured
by Given Imaging Ltd. The Company expects to file for clearance of PillCam
COLON with the U.S. Food and Drug Administration by the end of 2006. The
capsule measures 11 mm by 31 mm -- roughly the size of a large vitamin
pill. Since the lumen of the colon is wider than the small bowel and it is
highly compartmentalized, the Company has integrated new features into
PillCam COLON. The capsule has tiny cameras at each end which capture 4
images a second for up to 10 hours. Each camera contains automatic lighting
control and captures more than twice the coverage area and depth of field
of the PillCam™ SB capsule that is used to diagnose diseases in the
small intestine. Multi-center trials are underway in Europe and the U.S.
A patient swallows the PillCam COLON capsule with a glass of water. A prep,
as well as additional prokinetic agents to enhance capsule propulsion, are
also part of the PillCam COLON capsule procedure. The platform for PillCam
COLON includes the same components as PillCam SB and ESO including a sensor
array and data recorder. Upon completion of the procedure, the physician
downloads the recorded data to a RAPID workstation to review the images.
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 three commercially 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 50 other countries; the PillCam ESO video
capsule to visualize the esophagus; and the Agile™ patency capsule to
determine the free passage of the PillCam capsule in the GI tract. The
PillCam COLON video capsule to visualize the colon has been cleared for
marketing in the European Union and clinical trials are underway in the
United States to support submission for marketing clearance from the FDA. A
capsule to visualize the stomach is under development. More than 400,000
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 direct sales and marketing
operations in the United States, Germany and France, and local offices in
Japan, Spain and Australia. 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,"
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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) 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) the reimbursement policies for our
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and "Operating Results and Financial Review and Prospects" in the Company's
Annual Report on Form 20-F for the year ended December 31, 2005. 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
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any revisions to any forward-looking statements, to report events or to
report the occurrence of unanticipated events.