Healthcare Industry News: Capsule Endoscopy
News Release - June 27, 2007
Given Imaging Receives Reimbursement Clearance for PillCam(TM) SB From Japan's Central Health Insurance CommitteeReimbursement Coverage Includes Entire Adult Population in Japan
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Jun 27, 2007 -- Given Imaging Ltd. (NasdaqGM:GIVN ), the global leader in Capsule Endoscopy, today announced that Japan's Chuikyo (Central Social Health Insurance Committee) has approved reimbursement for the company's PillCam(TM) SB capsule endoscope. Effective October 1st, 2007, Japan's entire adult population will be eligible for reimbursement of the PillCam SB procedure for small bowel indications with obscure GI bleeding. This announcement follows approval from Japan's Ministry of Health, Labor and Welfare (MHLW) to market and sell the PillCam SB capsule endoscope in Japan on April 23rd of this year. Japan is believed to be the world's second largest healthcare market.
Homi Shamir, president and CEO of Given Imaging, said, "This is an important day for our company as it means that patients in Japan who suffer from abdominal symptoms can now be diagnosed using PillCam SB, a proven patient-friendly, effective procedure. We are very pleased that Chuikyo issued its reimbursement decision well ahead of our expectations and will continue to work closely with our Japanese partners to educate gastroenterologists throughout the country and accelerate sales of PillCam SB. In the future, we will introduce the rest of our product line including the PillCam SB 2, PillCam ESO 2, AGILE patency and PillCam COLON into the Japanese market."
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 60 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile(TM) 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 500,000 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) the reimbursement policies for our product from healthcare 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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