Healthcare Industry News: Capsule Endoscopy
News Release - October 11, 2007
Given Imaging Announces National Government Services Expands Policy to Cover Capsule Endoscopy of the EsophagusCarrier Also Expands Coverage for PillCam(R) SB
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Oct 11, 2007 -- Given Imaging Ltd. (NasdaqGM:GIVN ), the global leader in Capsule Endoscopy, today announced that National Government Services (NGS), the Medicare Part B Carrier serving more than 6 million individuals in New York, New Jersey, Kentucky and Indiana, issued a new coverage policy for cirrhotic patients for the evaluation of esophageal varices using Capsule Endoscopy of the esophagus. The policy becomes effective December 1, 2007. With the addition of the NGS coverage policy to the existing coverage policies, more than 13 million beneficiaries in the United States could have access to PillCam ESO.
Douglas T. Dieterich, M.D., Professor of Medicine, Liver Diseases, Director, Continuing Medical Education, Department of Medicine, Mount Sinai School of Medicine, New York City, said, "Esophageal varices are a major complication of liver cirrhosis and are associated with a rate of mortality of 20%. By allowing Medicare patients access to this less invasive technology, NGS is taking great strides to ensure cirrhotic patients are being evaluated, which will help improve the quality of care for these patients."
Varices are varicose veins that occur in the esophagus as a result of portal hypertension, which is a symptom of cirrhosis. The increased pressure within esophageal varices makes them susceptible to rupture and bleeding. Approximately 360 of every 100,000 Americans have cirrhosis, and gastroesophageal varices are present in 40-60% of these patients.
The company also announced that NGS has added coverage for PillCam SB for the detection of small bowel tumors, evaluation of malabsorption syndrome, and small bowel evaluation prior to a small bowel surgical resection to control loss of blood or protein. Multiple additional ICD-9 codes have also been added.
About PillCam ESO
Cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way, physicians can use PillCam ESO to aid in the detection of disorders such as Barrett's esophagus, a potential precursor for esophageal cancer and esophageal varices, which if left untreated, can result in fatal bleeding. PillCam ESO contains imaging devices and light sources at both ends of the capsule that capture up to 14 images per second, a total of 2,600 color images, as it passes down the esophagus in a twenty minute procedure. Exclusive marketing rights for PillCam ESO have been granted to InScope, a division of Ethicon Endo-Surgery, a Johnson & Johnson company.
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. More than 560,000 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.
About Ethicon Endo-Surgery
Ethicon Endo-Surgery, Inc., an operating company of Johnson & Johnson, is a global leader in minimally invasive and traditional surgical devices for bariatric surgery and many other areas of surgery. The company develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, plastic surgery, orthopedics, gynecology and surgical oncology. More information on the company can be found at www.ethiconendo.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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