YOQNEAM, ISRAEL--(Marketwire - April 10, 2008) - Given Imaging Ltd. (NASDAQ: GIVN) today announced a study in the May issue of Endoscopy found PillCam® COLON to be a cost-effective approach to preventing colo-rectal cancer (CRC) when used in the average-risk, general population that fails to comply with current CRC screening guidelines. The aim of the analysis was to provide a model to assess the cost and effectiveness of population-based screening for CRC using capsule endoscopy compared with that of a standard colonoscopy screening program. The study was conducted by Professor Cesare Hassan, M.D. of the Gastroenterology and Digestive Endoscopy Unit of the Nuovo Regina Margherita Hospital in Rome.
“PillCam COLON holds great promise in improving compliance to CRC screening standards in the general population,” Dr. Hassan said. “CRC screening rates remain disappointingly low when compared to the success of other cancer screening programs. Colo-rectal cancers are preventable through early detection, and this non-invasive option may aid in significantly reducing the more than 212,000 annual deaths in Europe due to colo-rectal cancer.”
The researchers showed that the cost effectiveness of CRC screening using the PillCam® COLON will mainly depend on its ability to improve compliance in the general population. Given past uptake evidence seen with capsule endoscopy in other areas of the GI tract (small bowel, esophagus), Dr. Hassan and his colleagues state that there is a “ubiquitous expectation” that capsule examinations will achieve better acceptance and thus will increase compliance to screening. If such uptake mirrors that for other cancer screenings, the authors conclude, capsule endoscopy will be an efficient strategy for CRC prevention, with cost-effectiveness potentially superior to colonoscopy.
The study employed a mathematical Markov model(1) and simulated a comparison of CRC screening scenarios comparing PillCam® COLON with standard colonoscopy. Model parameters were varied to simulate alterations in cost, thresholds for treatments, sensitivities and specificities, and screening adherence rates. Through pooled analyses, it was determined that a greater than or equal to 6 mm threshold for polypectomy referral substantially reduced costs while only minimally impacting efficacy.
PillCam® COLON received the CE Mark in Europe in October 2006 and is available in select clinics across Europe. Given Imaging now markets three video capsules: PillCam® COLON, PillCam® SB for the small bowel and PillCam® ESO for the esophagus, as well as the Agile™ patency capsule.
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. PillCam COLON utilizes advanced optics technology, which have been specially adapted for the wider lumen and high degree of compartmentalization that characterizes colon physiology.
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™ 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 650,000 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.
(1) Markov models are useful when a decision problem involves risk that is continuous over time, when the timing of events is important, and when important events may happen more than once - http://www.ncbi.nlm.nih.gov/pubmed/8246705
For further information contact:
Fern Lazar David Carey Lazar Partners Ltd. 1-866-GIVEN-IR
