Healthcare Industry News: Capsule Endoscopy
News Release - January 28, 2008
Given Imaging Announces German Public Health System to Initiate Reimbursement Process for PillCam(TM) SBYOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Jan 28, 2008 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced that the German Gemeinsame Bundesausschuss (Joint Federal Committee) declared that it will begin to evaluate Capsule Endoscopy for out-patient coverage under the German national insurance program which covers most of Germany's 82 million citizens. About 10 percent of German citizens currently have coverage for PillCam(TM) SB through private health insurers.
"We are pleased that the German public health system will evaluate PillCam SB so that all German citizens can benefit from a diagnostic tool proven to be an effective and patient-friendly way to detect small bowel diseases. We anticipate a decision in the next 12 to 18 months," said Homi Shamir, president and CEO of Given Imaging. "Today's news is yet another example of the progress we are making in achieving reimbursement around the world. In addition to previously announced decisions in major markets including the U.S., Japan and the U.K, we also expect to receive a monetary code for reimbursement in France in the first half of 2008, as well as additional reimbursement polices for PillCam SB and PillCam ESO in the U.S and other countries this year."
Within two to three months, the Joint Federal Committee is expected to solicit input from medical experts, scientific societies, professional associations and patient organizations. Thereafter the Committee will deliberate on reimbursement. Assuming a positive outcome, the Committee would then recommend coding and initiate the monetary valuation for the procedure.
Given Imaging European headquarters have been based in Hamburg, Germany since 2001.
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, and is pending clearance with the United States Food and Drug Administration. More than 600,000 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. 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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