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Press Releases
Funding Application Supported by Largest Body of Clinical Data on PillCam Capsule Endoscopy YOQNEAM, ISRAEL--(Marketwire), 15 May 2008 -- Given Imaging Ltd. (NASDAQ: GIVN) today announced that the Australian Government Department of Health and Ageing has approved permanent Medicare funding for capsule endoscopy of the small bowel. Capsule endoscopy has been interim Medicare funded in Australia subject to data collection since May 2004. Medicare is the scheme that gives all Australian residents access to subsidized health care. The Australian PillCam database was developed and supported by members of the Gastroenterological Society of Australia (GESA) in collaboration with Given Imaging and resulted in a database of 2,949 patients. This data set is the largest body of data ever accumulated on PillCam SB® and the largest data set ever submitted to the Medical Services Advisory Committee (MSAC). MSAC is the committee that advises the Australian Federal Minister for Health and Ageing on the safety, efficacy and cost-effectiveness of new medical procedures and technologies. "We are pleased to receive permanent Medicare funding for PillCam SB in Australia, which is an important milestone for Given Imaging," said Homi Shamir, president and CEO of Given Imaging. "Importantly, it reflects the successful collaboration between our company, the GI community and the Australian Government to ensure that such decisions are based on clinical evidence that demonstrated PillCam's safety, efficacy and cost-effectiveness. We thank the Australian Gastroenterological Society for their leadership in this process and look forward to working with them in order to obtain reimbursement for additional indications for PillCam SB in the future." Some of the key findings from the database include: 1. A finding of GI abnormalities in 71.1% of patients (compared to the 59.9% assumed in MSAC Assessment Report #1057, based on clinical trial data); 2. An estimated average cost reduction of AUD 2,667 per patient in other investigational procedures including colonoscopy, enteroscopy and small bowel follow through in the 12 months following PillCam capsule endoscopy; 3. Cost savings, based on a reduction in hospitalisation rates from 44.6% in the year prior to PillCam capsule endoscopy to 11.6% in the year post PillCam capsule endoscopy. The company intends to work with the GI community to continue to analyze the database and submit studies for presentation at future medical society conferences. 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™ 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 700,000 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 (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, 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. Media Contacts: For further information contact: Fern Lazar David Carey Lazar Partners Ltd. 212 867 1768 Submitted by Asia Release on Thursday, 15 May 2008 at 12:00 PM Category: Health Care & Medical |
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