YOQNEAM, ISRAEL--(Marketwire - July 9, 2008) - 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® 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:
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.
Contact Information: For further information contact:
Fern Lazar
David Carey
Lazar Partners Ltd.
1-866-GIVEN-IR