Contact Information: For further information contact: Matthias Stief Given Imaging Ltd. +49 (162) 211 6613 or Fern Lazar/David Carey Lazar Partners Ltd. 1-212-867-2355 /
Given Imaging Announces Clinical Data Presented During United European Gastroenterology Week
New Interim PillCam(R) COLON Data Presented From Largest Prospective Capsule Endoscopy Study
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - October 29, 2007) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that clinical data on PillCam COLON and PillCam® SB will be
presented during United European Gastroenterology Week (UEGW), Europe's
largest gastroenterology conference, in Paris, France from October 27-31.
Stanislas Chaussade, M.D., Head of Gastroenterology at the Hôpital Cochin
in Paris said, "The capsule endoscopy data presented this week at UEGW
shows how important this procedure has become to the field of
gastroenterology. New indications for PillCam SB continue to emerge
validating its long-term benefits for patients with unexplained small
intestinal disorders. While still a relatively new video capsule, PillCam
COLON continues to show great promise, especially in the area of colorectal
cancer screening where in Europe less than 10% of patients are compliant."
Data highlights included:
PillCam COLON
Jacques Devière, M.D., Chairman of the Department of Gastroenterology and
Hepatology at Erasme University Hospital, Brussels, Belgium, and president
of the European Society of Gastrointestinal Endoscopy presented interim
results from a prospective study on PillCam COLON involving eight centers
from six European countries. The aim of the study is to assess PillCam
COLON's yield in detecting polyps, cancers and other pathologies in the
colon compared to traditional colonoscopy in 329 patients. This is the
largest prospective capsule endoscopy study conducted to date.
Interim findings from 166 patients with a mean age of 60, with known or
suspected colonic disease were presented. Each patient did a colon prep
and ingested the PillCam COLON video capsule in the morning. Once the
capsule was excreted, patients also underwent colonoscopy. Independent
physicians performed the exams and were blinded to each others' results.
Significant findings were defined as at least one polyp measuring 6 mm or
three or more polyps of any size.
The capsule completed the examination and was excreted from the body within
10 hours post ingestion in 96% of the patients. No severe adverse events
were related to the capsule. Colonoscopy detected significant findings in
46% (n=75) of patients. The sensitivity/specificity for PillCam COLON to
detect significant findings was 72%/80%. The investigators concluded that
PillCam COLON could eventually be used for polyp detection and increase
compliance for CRC screening.
PillCam SB
Small Bowel Tumors
A retrospective study led by Erik Peter Skogestad, M.D. at Innlandet
Hospital Trust Lillehammer in Norway assessed the prevalence of small bowel
tumors found by capsule endoscopy in obscure bleeding patients. Of the
195-patient cases studied, capsule endoscopy detected small bowel tumors in
5.6% of patients (n=11). However, when the indication was obscure GI
bleeding (n=73), the tumor detection rate increased to 12.3% (n=9). The
investigators concluded that one in eight capsule endoscopy procedures
performed found a small bowel tumor when the indication was obscure GI
bleeding, a higher incidence rate then previously reported.
Iron Deficiency Anemia
Led by Michel Delvaux, M.D. Professor, Hôpitaux de Brabois in France, this
retrospective study compared the clinical characteristics in chronic
iron-deficiency anemia (CIDA) and obscure GI bleeding patients and
evaluated the diagnostic yield of capsule endoscopy in patients
specifically with CIDA. Two groups of patients were selected from a
database of 604 patient case studies conducted between 2002 and 2006. Group
I consisted of 93 CIDA patients and Group II consisted of 233 patients with
obscure GI bleeding.
The overall diagnostic yield of capsule endoscopy in Group I was 68.8%
compared to 78.5% for Group II. Active bleeding was found in 3% of patients
in Group I vs. 10% in Group II and intestinal tumors in 4 patients in Group
I vs. 19 in Group II.
The study concluded that capsule endoscopy has a high diagnostic yield in
CIDA patients but a lower yield when compared to patients with obscure GI
bleeding. It was recommended that capsule endoscopy be performed early in
the diagnostic work-up of patients with CIDA to help physicians determine
the next course of action.
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 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; 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 and is pending clearance with the
United States Food and Drug Administration. More than 600,000 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 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 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.