Healthcare Industry News: endoscopy
News Release - February 20, 2008
Given Imaging Announces PillCam(R) COLON Approval in IsraelYOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Feb 20, 2008 -- Given Imaging (NasdaqGM:GIVN ), the global leader in capsule endoscopy, today announced that Israel's Ministry of Health, Health Technology and Infrastructure Administration has approved PillCam® COLON, the first capsule endoscope to enable physicians to visualize and evaluate diseases of the colon.
"We are pleased that the Israeli Health Ministry has approved PillCam COLON. We will be working with gastroenterologists throughout the country to educate them on this non-invasive alternative for imaging the colon," said Homi Shamir, president and CEO of Given Imaging.
"Colon Cancer is preventable if detected early, but less than 25% of individuals in Israel over the age of 50 are screened for colon cancer. PillCam COLON offers a non-invasive alternative for individuals who cannot or do not wish to undergo colonoscopy and presents an opportunity to increase adherence to colorectal cancer screening guidelines and save lives," said Dr. Rami Eliakim, Chair of Medicine and Director of the Department of Gastroenterology at Rambam Medical Center, Haifa, Israel.
As reported in a recent meeting of the Israeli Gastroenterology Society, it is estimated that approximately 75 percent of Israelis do not undergo the recommended screening. Colorectal cancer accounts for 1,300 deaths in Israel annually.
About PillCam COLON
PillCam COLON enables the physician to directly see the colon mucosa in its natural state while not requiring sedation, intubation, insufflation, hospitalization or radiation. The PillCam COLON 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 capture 4 images per second for up to 10 hours. PillCam COLON utilizes advanced optics technology, similar to the technology found in the second generation PillCam SB and ESO capsules, which produces enhanced resolution images and include automatic light control and a wide field of view.
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. 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 and Australia. 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, 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.
Source: Given Imaging
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