Healthcare Industry News: InScope
News Release - June 14, 2007
Given Imaging Receives U.S. Marketing Clearance for PillCam(R) ESO 2Next-Generation Capsule Endoscope Offers Enhanced Imaging, Wider View of Esophagus
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Jun 14, 2007 -- Given Imaging Ltd. (NasdaqGM:GIVN ), the global leader in capsule endoscopy, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next-generation PillCam® ESO 2 video capsule for imaging the esophagus. Exclusive U.S. marketing rights for PillCam ESO have been granted to InScope, a division of Ethicon Endo-Surgery, a Johnson & Johnson company.
Homi Shamir, president and CEO of Given Imaging, said, "We wanted to develop an esophageal video capsule that would give physicians a more precise view of a patient's mucosa and suspected pathology and we believe we accomplished that with the advanced optics and wider view range of PillCam ESO 2. This next-generation esophageal video capsule is designed to help physicians more easily diagnose disorders such as Barrett's esophagus and esophageal varices, a dangerous complication of liver cirrhosis."
PillCam ESO 2 features include:
-- Improved image quality
-- A 21% increase in the angle of view over PillCam ESO providing physicians more than a 100 percent increase in mucosal tissue coverage
-- Added Automatic Light Control (ALC) to provide optimal illumination for each image
-- Increased capture rate of 18 frames per second (fps), capturing 30% more images
-- Up to 30 minutes operating time
-- Same dimensions as PillCam ESO
PillCam ESO 2 will be supported by the PillCam® Platform with RAPID® 5 software and available for shipment to customers before the end of the year.
About Ethicon Endo-Surgery, Inc.
Ethicon Endo-Surgery, Inc. 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, gynecology and surgical oncology. More information on the company can be found at www.ethiconendo.com
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 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) 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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