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Given Imaging Announces Highlights of Sixth International Conference on Capsule Endoscopy(TM)
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - June 12, 2007) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced highlights from the 6th International Conference on Capsule
Endoscopy™ (ICCE™), which took place in Madrid, Spain, June 8 - 9,
2007. Jacques Devière, M.D., ULB Hôpital Erasme, Brussels, Belgium and
Juan A. Ramirez-Armengol, M.D., Hospital Clínico San Carlos, Madrid, Spain
co-chaired the meeting that included more than 80 abstracts, posters and
case studies presented by gastroenterologists from 34 countries on capsule
endoscopy in the small bowel, colon and esophagus.
"ICCE Madrid is an opportunity for physicians to share the latest
scientific and clinical data, as well as practical information about new
applications of capsule endoscopy," said Roberto de Franchis, Professor of
Medicine at the University of Milan, Italy and Honorary President of ICCE.
"Among the most interesting presentations were those that validated capsule
endoscopy's ability to change patient management and, subsequently,
clinical outcomes through earlier detection and definitive diagnosis of
gastrointestinal cancers, Crohn's disease and life-threatening sources of
bleeding."
Among the highlights at this year's ICCE were studies presented on:
Colon capsule endoscopy
In a session entitled "Scientific Evidence of PillCam Colon CE," co-chair
Jacques Devière, presented the interim results of a European multi-center
clinical trial of 329 patients to assess the yield of PillCam Colon capsule
endoscopy (Colon CE) in detecting polyps and other pathologies compared to
traditional colonoscopy. Patients included in this study were known to
have or suspected of having colonic disease and were referred for
colonoscopy. Patients went through a traditional PEG colon prep and
ingested the capsule in the morning. The procedure included prokinetic
agents and additional small doses of laxatives. Independent physicians
performed capsule imaging analysis and traditional colonoscopy ("gold
standard") after excretion. Significant findings were defined as at least
one polyp greater than or equal to 6 mm or greater than or equal to 3
polyps of any size. Based on an interim analysis of results in 84 patients,
the study's authors concluded that Colon CE showed encouraging sensitivity
and negative predictive values for detection of significant findings
compared to colonoscopy, and if these data are further validated at the
conclusion of this study, this new non-invasive technology might challenge
colonoscopy for CRC screening and polyps detection.
Iron-Deficiency Anemia
Researchers at the CHU de Nancy, Internal Medicine and Digestive Pathology,
France led by Michel Delvaux M.D., conducted a study to compare the
clinical characteristics of patients with chronic iron-deficiency anemia
(CIDA) and patients with occult gastrointestinal bleeding (OGB) and to
evaluate the diagnostic yield of capsule endoscopy (CE) in patients with
CIDA. Two groups of patients were selected from a cohort of 604 consecutive
patients investigated with CE between 01/2002 and 12/2006. Based on the
results of the study, the study authors concluded that while CE has a high
diagnostic yield in patients with CIDA, it has a higher yield in patients
with OGB suggesting that CE should be performed early in the work of
patients with CIDA to help to direct further investigations.
Inflammatory Bowel Disease
An interim analysis of a multi-center Australian study of CE in suspected
small bowel Crohn's Disease (SB CD) led by Warwick Selby, M.D. of Royal
Prince Alfred Hospital Sydney, sought to determine the diagnostic ability
and clinical impact of CE for suspected SB CD in symptomatic patients with
a non-diagnostic standard work-up including colonoscopy and SB
follow-through within 6 months of enrollment. Of the 51 patients who had
completed the study to date, a preliminary analysis of entry criteria
showed that CE was able to diagnose SB CD in 22% of subjects. Raised
inflammatory markets or anemia made a diagnosis of CD more likely. These
results need to be confirmed by analysis of the full cohort.
Bleeding
Fifty-three Australian physicians participated in a national registry
established by the Gastroenterological Society of Australia and the
Australian Capsule Endoscopy Interest Group to determine the long-term
diagnostic benefit, safety and cost-effectiveness of capsule endoscopy in
patients with obscure GI bleeding (OGIB). The participating physicians
performed 2,949 CE procedures on patients who had previously undergone
upper endoscopy and colonoscopy. Prior to undergoing the CE procedure, the
patients had undergone an average of 3.6 diagnostic procedures, including
1.6 endoscopies and 1.5 colonoscopies. The average cost of these
procedures was A$3,282. In addition, 37% of patients were admitted to the
hospital in the 12 months before capsule endoscopy. During the study
period, the cost-per-patient decreased 21%. In a follow up of 420 studies,
the cost of investigation decreased to A$324, and only 11% of patients
required hospital admission. The study confirmed the high diagnostic yield
of CE for OGIB in a large patient population and confirmed safety and cost
effectiveness.
Esophageal Varices
Victor Fox, M.D. of Children's Hospital in Boston, Massachusetts conducted
a 27-patient study to determine the feasibility of using PillCam ESO in
children and young adults with esophageal varices, a dangerous complication
of liver cirrhosis and portal hypertension that can lead to
life-threatening bleeding. The study concluded that PillCam ESO is a
feasible alternative to conventional endoscopy for screening and
surveillance of esophageal varices.
Latest Advances
Physicians at the Mayo Clinic College of Medicine, department of
Gastroenterology and Hepatology, Scottsdale, Arizona conducted a
meta-analysis of eleven studies including approximately 749 patients
comparing the diagnostic yield of capsule endoscopy and double-balloon
enteroscopy (DBE) in patients with suspected small bowel disease.
Physicians concluded that capsule endoscopy and DBE had a comparable
diagnostic yield, and that capsule endoscopy should be the diagnostic test
of choice due to its
non-invasive nature.
About ICCE
Started in 2002, the International Conference on Capsule Endoscopy™ is
the main forum for leading gastroenterologists and key opinion leaders to
exchange scientific, clinical and practical information about capsule
endoscopy. For more information visit www.icce.info
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 60 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 multi-center clinical trials are
underway in Europe and the U.S. A capsule to visualize the stomach is under
development. More than 500,000 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,"
"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) the reimbursement policies for our
product from healthcare 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, 2006. You are cautioned not
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only as of the date of this press release. Except for the Company's
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revisions to any forward-looking statements, to report events or to report
the occurrence of unanticipated events.