Healthcare Industry News: Capsule Endoscopy
News Release - May 19, 2008
Study Confirms PillCam(R) COLON's Potential as a Complement to Colonoscopy to Increase Colo-Rectal ScreeningsPillCam(R) COLON Shows Encouraging Results Compared to Traditional CRC Screening Methods
YOQNEAM, ISRAEL and SAN DIEGO, CA--(Healthcare Sales & Marketing Network)--May 19, 2008 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced the results of an eight-center European study confirmed that PillCam® COLON demonstrates encouraging results for detecting colo-rectal polyps compared to colonoscopy. The results were presented at the Digestive Disease Week® (DDW) 2008 conference taking place in San Diego. The prospective study was led by Jacques Deviere, M.D., Erasme Hospital in Brussels.
"The promise of PillCam COLON is increasing the number of colo-rectal screenings, which remain disappointingly low in Europe. This patient-friendly alternative could become a key tool in the effort to reduce the more than 212,000 colo-rectal cancer (CRC) deaths annually in Europe," said Prof. Deviere. "Patients who can't or are unwilling to undergo a colonoscopy have a new way to be screened in a very easy, painless way. If polyps or cancerous lesions are found, then the physician can perform a subsequent procedure to remove the lesions. The initial data on PillCam COLON is extremely promising and we look forward to additional clinical information to determine how best to use this valuable diagnostic tool."
The primary objective of the study was to assess the accuracy of PillCam COLON in detecting polyps as compared to traditional colonoscopy. The eight-center trial enrolled 320 patients, with a mean age of 59 years. Prior to capsule ingestion, patients underwent a traditional colon prep after a one-day liquid diet. The procedure included prokinetic tablets and additional small doses of laxatives. No sedation, intubation or insufflation was required. After Capsule Endoscopy with PillCam COLON, an independent physician performed traditional colonoscopy.
Capsule Endoscopy with PillCam COLON showed sensitivity (the ability to positively identify disease) of 66%, with specificity (the ability to avoid a false positive) of 82% in identifying significant findings, with a positive predictive value (the percent who test positive when confirmed to have the condition) of 72% and a negative predictive value (the percent who test negative who are confirmed not to have the condition) of 77%. Significant findings were defined as at least one polyp larger or equal to 6 mm or 3 polyps of any size. For polyps larger or equal to 6 mm and 10 mm, Capsule Endoscopy showed sensitivity of 64% and 60% and specificity of 84% and 98% respectively.
About PillCam COLON
Capsule Endoscopy with PillCam COLON enables the physician to directly see the colon mucosa in its natural state while not requiring sedation, intubation, insufflation or radiation. The PillCam COLON video capsule is a smooth plastic capsule that measures 11mm by 31mm and can be naturally ingested with a sip of water. It has tiny video cameras at each end which together capture 4 images per second for up to 10 hours. The PillCam COLON video capsule utilizes advanced optics technology, which have been specially adapted with a wide lumen and high degree of compartmentalization that characterizes colon physiology.
PillCam COLON received the CE Mark in Europe in October 2006 and is available in select clinics across Europe. It also has been cleared in Australia, Canada, Israel and parts of Latin America.
*PillCam COLON is not cleared for marketing or available for commercial distribution in the USA.
About Digestive Disease Week
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
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(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, 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 & TASE: 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.
Source: Given Imaging
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