PillCam Capsule Endoscopy of the Small Bowel Provides New Information; May Lead to More Precise Treatment and Better OutcomesYOQNEAM, ISRAEL, Jul 09, 2008 (MARKET WIRE via COMTEX News Network) -- Given Imaging Ltd. (NASDAQ: GIVN) (TELAVIV: GIVN) today announced a
study published in the July issue of the Journal of Pediatric
Gastroenterology and Nutrition found PillCam capsule endoscopy of the
small bowel may enable more targeted and effective therapies for
children with Crohn's disease. According to the study, the
opportunities for improved treatment regimens were a direct result of
reclassifying inflammatory bowel disease (IBD) from ulcerative or
indeterminate colitis to definitive Crohn's disease and from
uncovering a more significant burden of small bowel disease for those
children already diagnosed with Crohn's disease.
The retrospective cohort analysis was conducted by Stanley Cohen,
M.D., of the Children's Center for Digestive Healthcare in Atlanta,
Georgia.
"PillCam SB is a valuable tool that allows gastroenterologists to
make better medical decisions and tailor pharmacological management,
resulting in improved patient outcomes for those who suffer from IBD,"
said Dr. Cohen. "Information obtained through PillCam SB capsule
endoscopy can enable us to reclassify disease or understand the full
extent to which the disease is affecting patients, thus facilitating
more targeted and effective treatment regimens."
The retrospective cohort analysis examined the medical records of
patients from ages two to 18 years of age who had been previously
diagnosed with Crohn's disease, ulcerative colitis or indeterminate
colitis and whose disease had flared within the previous three years,
leading to capsule endoscopy. Twenty-eight (28) patients met the
criteria for inclusion in the study. Key findings include:
-- 71% (5/7) of patients with ulcerative or indeterminate colitis had
small bowel CE findings that led to reclassification of disease (from
ulcerative or indeterminate colitis to Crohn's disease), resulting in a
change in medical management.
-- 62% (13/21) of patients with Crohn's disease were found to have more
extensive (more proximal) small bowel disease than previously identified,
92% of which occurred in the jejunum, suggesting that pediatric Crohn's
disease may involve the proximal small bowel more than previously reported.
-- Of those with previously unrecognized jejunal disease, 92% (11/12) of
treatment regimens were altered based upon the new CE findings.
The study authors also noted an additional benefit of CE was to help
patients and their parents better understand the disease process and
rationale for therapeutic recommendations.
The PillCam SB 2 video capsule, when used with the PillCam Platform,
is intended for visualization of the small bowel mucosa. It may be
used as a tool in the detection of abnormalities of the small bowel
in adults and children from 10 years of age and up. The PillCam SB 2
video capsule and PillCam Platform are not cleared for use in
children under 10 years of age and should not be used outside of the
context of approved clinical trials with such patients.
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(R) 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(R) 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(TM) 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: ELRN) (TELAVIV: 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.
For further information contact:
Fern Lazar
David Carey
Lazar Partners Ltd.
1-866-GIVEN-IR
SOURCE: Given Imaging