European Consortium Developing GI Tract Cancer Screening SystemJanuary 18, 2007
Given Imaging collaborates with other companies to develop the PillCam capsule endoscope. This tiny, disposable camera and sensing array combines image and molecular analysis to screen for cancer of the gastrointestinal tract.
YOQNEAM, ISRAEL -- (MARKET WIRE) --Given Imaging Ltd. (NASDAQ: GIVN) today announced that it has received approval from the European Commission of the Sixth EU Framework Program of Research and Technological Development ("FP6 commission") to lead a consortium that will develop an integrated imaging-biosensing system to screen for cancer of the gastrointestinal (GI) tract. The "nano-based capsule-endoscopy with molecular imaging and optical biopsy" (NEMO) project kicked off in Tel-Aviv at the end of November.
In addition to Given Imaging, the consortium includes Zarlink Semiconductor (Sweden and UK), Fraunhofer Institute for Biomedical Engineering, Israelitic Hospital and Indivumed (Germany), Imperial College of Science, Technology and Medicine (London, England), ITC-irst Research Institute (Italy), The Hebrew University of Jerusalem, Novamed, and Ernst & Young (Israel). The NEMO Group will invest EUR 4.7 million over the next three years, of which the European Commission will contribute EUR 2.8 million. Given Imaging's gross and net contribution is EUR 1.3 million and EUR 0.6 million, respectively.
The objective of the NEMO project is to increase patient compliance with currently recommended screening guidelines by developing an advanced cancer screening system that is patient-friendly, highly sensitive and specific for early detection of cancer. To achieve this NEMO will converge optical technologies with Nano-technologies, biosensing and maneuvering technologies to create a unique PillCam capsule endoscope capable of secretion analysis and the detection of marked and deep tissue disorders. The consortium believes the combination of the image and molecular analysis to mark the tumor may provide a novel and effective medical device for mass screening for GI cancer.
"We are proud to advance our research in the biosensing field with such leading research and industrial organizations," said Elisha Rabinovitz, DSc, chief scientist of Given Imaging and the consortium coordinator. "This project further exemplifies Given's commitment to develop new and innovative solutions to help physicians treat their patients and could represent a revolutionary platform of biopsy free procedures."
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 50 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 400,000 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 the company's Web site.
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) 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 impact of the newly adopted SFAS 123R for expensing option-based payments, (11) the possibility of armed conflict or civil or military unrest in Israel, and (12) 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, 2005. 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.
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