Healthcare Industry News: Capsule Endoscopy
News Release - October 20, 2008
PillCam(R) COLON Shows Substantial Agreement With Gold Standard Colonoscopy in Detection of Ulcerative ColitisActive Ulcerative Colitis an Acknowledged Colorectal Cancer Risk Factor
VIENNA, AUSTRIA--(Healthcare Sales & Marketing Network)--Oct 20, 2008 -- Given Imaging Ltd. (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(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 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 (ELRN ) (Tel Aviv:ELRN.TA ). For more information, visit 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) 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.
Source: Given Imaging
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.