Healthcare Industry News: endoscopy
News Release - November 21, 2008
Given Imaging Announces French Health Ministry Finalizes Reimbursement for PillCam SB64 Million French Citizens Now Have Reimbursed Access to Non-Invasive Tool for Diagnosing Small Bowel Disease
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Nov 21, 2008 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced that the French Ministry of Health has concluded the reimbursement process for PillCam® SB and set a pricing level of 418EUR without VAT. The decision was published in the Journal Officiel on November 21, 2008. Now all of France's 64 million citizens will have reimbursable access to Pillcam SB for the following indications:
- Unexplained obscure and occult GI bleeding after negative colonoscopy and EGD (upper endoscopy)
- Iron deficiency anemia after negative colonoscopy and EGD
- Confirmation of suspected small bowel Crohn's disease following negative small bowel follow through and colonoscopy
"This is an important milestone for Given Imaging and we are very pleased that the French Ministry of Health has recognized the importance of capsule endoscopy for the small bowel. Gastroenterologists throughout France will now be able to offer their patients PillCam SB to diagnose and treat gastrointestinal disease," said Homi Shamir, president and CEO of Given Imaging. "Today, approximately 560 million individuals worldwide including 235 million Europeans have reimbursed access to PillCam SB. We are working diligently to advance this process and we expect additional reimbursement decisions from other major European health ministries in the future."
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 820,000 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 (NasdaqGS:ELRN ) (Tel Aviv:ELRN.TA ). 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) 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
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