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PillCam(R) COLON Shows Substantial Agreement With Gold Standard Colonoscopy in Detection of Ulcerative Colitis
Active Ulcerative Colitis an Acknowledged Colorectal Cancer Risk Factor
| Source: Given Imaging
VIENNA, AUSTRIA--(Marketwire - October 20, 2008) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that interim results of a study presented at the 16th United
European Gastroenterology Week (UEGW) 2008 conference taking place in
Vienna, Austria, from October 18 - 22, demonstrated substantial agreement
with colonoscopy in the detection of active ulcerative colitis (UC).
Active UC is associated with an increased risk of colorectal dysplasia and
cancer, and regular surveillance is required(1).
"Patients with ulcerative colitis may be more willing to undergo
surveillance using the patient-friendly option offered by PillCam COLON,"
said J.J.Y. Sung, MD, Chinese University of Hong Kong. "Every step that we
can take toward minimizing the impact of colorectal cancer (CRC) is
critical. CRC is the second-leading cause of cancer death in the Western
world(2) and one of the most preventable forms of cancer(3)."
The interim analysis of 42 patients assessed the accuracy of PillCam COLON
capsule endoscopy in detecting inflammatory lesions and UC compared to
traditional optical colonoscopy. Patients who were included were 18 - 70
years old and had been referred to optical colonoscopy for suspected or
known inflammatory lesions or other colonic disease. Patients underwent a
traditional PEG colon prep, ingested the capsule in the morning and
consumed additional laxatives thereafter to maintain clean colon and propel
the capsule. Following capsule excretion, optical colonoscopy was
performed. The physicians who performed colonoscopy and those who analyzed
PillCam capsule results were blinded to each other's data.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease, characterized by inflammation of
the innermost lining of the colon, which often results in diarrhea and
abdominal pain. Loss of appetite, weight loss and fatigue are common.
Patients often experience symptoms sporadically, with remission periods
spanning months or years.(4)
For more information
The use of PillCam COLON will be highlighted in a breakfast symposium
sponsored by Given Imaging on Tuesday, October 21, at the Austria Center
Vienna, Hall F1, beginning at 7:00 a.m. "Evaluation of Colon Capsule
Endoscopy in the Visualization of the Colon" and "The Role of Colon Capsule
Endoscopy in the Detection of Ulcerative Colitis" will be part of the
program.
This interim study was partially sponsored by Given Imaging.
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
markets a number of available capsules: the second-generation PillCam SB 2
video capsule to visualize the entire small intestine which is currently
marketed in the United States and in more than 60 other countries; the
second-generation PillCam ESO 2 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 and various country approvals, but is
not cleared for marketing or available for commercial distribution in the
USA. More than 750,000 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 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, 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.
(1) http://www.emedicine.com/Med/topic2336.htm
(2) http://www.lavoisier.fr/notice/gb608467.html
(3) http://www.hmc.psu.edu/healthinfo/c/colon.htm
(4) http://www.ccfa.org/info/about/ucp