Given Imaging Announces New Capsule Endoscopy Reimbursement Policies for PillCam ESO and PillCam SB
Given Imaging Ltd. (NASDAQ: GIVN) today announced new capsule endoscopy reimbursement policies for PillCam(TM) ESO and PillCam(TM) SB.
Esophageal Capsule Endoscopy
First Coast Service Options, Inc., administrator of Florida and Connecticut Medicare, has updated its capsule endoscopy guidelines becoming the first third-party payor to designate PillCam ESO to be medically reasonable and necessary as a diagnostic tool for patients who are unable to undergo conventional endoscopy or are diagnosed with portal hypertension and require immediate evaluation of esophageal varices. The updated guidelines are effective October 30, 2006. First Coast Service Options provides benefits to over 3 million beneficiaries. For more information visit the Centers for Medicare and Medicaid website at: http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=13831&lcd_version=8&show=all#19.
Mark Gilreath, senior vice president of global marketing at Given Imaging, said, “We applaud First Coast Service for their commitment to delivering the best care to their patients and are pleased that they recognized the value that PillCam ESO holds for helping those patients who cannot undergo conventional endoscopy or are at risk for varices. We anticipate that other payors will recognize this value to help them deliver the best patient care.”
Small Bowel Capsule Endoscopy
Spain’s National Health Service has included capsule endoscopy for the small bowel in its portfolio of health services. Effective immediately, individuals with symptoms of persistent obscure gastrointestinal bleeding of presumed small bowel origin following negative upper and lower endoscopies may undergo the PillCam SB procedure at hospitals and clinics that offer it.
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(TM) 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(R) 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 50 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 400,000 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 direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain 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) 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 impact of the newly adopted SFAS 123R for expensing option-based payments, (11) the possibility of armed conflict or civil or military unrest in Israel, and (12) 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, 2005. 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.
For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR Contact via http://www.marketwire.com/mw/emailprcntct?id=28FCB11536F87128/ Contact via http://www.marketwire.com/mw/emailprcntct?id=9DF7BCEA4071D706
SOURCE: Given Imaging