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Given Imaging Launches New ManoView(TM) ESO v3.0 Software

Thu, 01/03/2013 - 7:00am
The Associated Press

Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the launch of ManoView™ ESO v3.0, the newest version of esophageal manometry analysis software for Given Imaging's ManoScan™ ESO platform, a convenient test used to deliver a complete physiological mapping of esophageal motor function, from the pharynx to the stomach, with the single placement of a catheter. ManoView ESO v3.0 includes many new features that will provide physicians with increased diagnostic confidence and an intuitive study overview for rapid and accurate identification of motility disorders.

The ManoView ESO v3.0 software is used to identify esophageal motility disorders including dysphagia, achalasia, and diffuse esophageal spasms (DES) and helps physicians diagnose and make appropriate recommendations for treatment. This software launch includes the latest Chicago Classification parameters whose major clinical benefit is a reduction in procedure time and improved clinical diagnosis.

"The new ManoView ESO v.3.0 is an important software upgrade that keeps pace with the recent improvements in manometric interpretation and classification," said John Pandolfino, MD, Northwestern Memorial Hospital, Chicago, IL. "This system is intuitive and demonstrates a high level of accuracy in data analysis and suggested classification."

Additional advanced capabilities supported by ManoView ESO v3.0 include expanded language support and Hospital Information System (HIS) compatibility. The ManoView ESO v3.0 software also features benefits such as reduced training requirements through a consistent and repeatable process, increased confidence in manometry analysis, and true three-dimensional visualization of the esophagogastric junction (EGJ).

About Digestive Motility Motility disorders occur when the natural muscle movements of the digestive tract that help to propel food content are impaired. These disorders can impact a portion or all of the digestive tract. Examples of digestive motility diseases and disorders include chronic intestinal pseudo-obstruction (CIP), gastroparesis, dysphagia, and diffuse esophageal spasm (DES)(1). Achalasia is a motility disorder that occurs when there is a complete lack of muscle movement within the esophagus, preventing food from entering the stomach. Symptoms are difficulty swallowing liquids and solids and can also include regurgitation, vomiting, weight loss and atypical chest discomfort.(2)

About ManoScan ESOManoScan ESO is a test used to assess esophageal motor function. This advanced diagnostic technology allows physicians to evaluate causes of reflux, difficulty swallowing, functional chest pain and pre-operative evaluations. As the first solid-state high resolution manometry technology, ManoScan is the global market leader in technologically advanced solutions for assessing gastrointestinal motility. It is the only platform validated for the Chicago Classification System, the industry's standardized categorization scheme for identification of motility disorders. All ManoScan ESO systems incorporate the new ManoView ESO v3.0.

About Given Imaging Ltd.Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan™ high-resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z, and the SmartPill® GI monitoring systems. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam, Hong Kong and Brazil. For more information, please visit www.givenimaging.com.

Forward-Looking StatementsThis 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. Such forward-looking statements include statements relating to the Company exploring strategic alternatives and considering possible strategic transactions involving the Company. 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 ability of the Company to reach agreement on any strategic alternative and/or to complete any such alternative, as well as the following: (1) our ability to develop and bring to market new products, (2) our ability to successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) lack of an appropriate bowel preparation materials to be used with our PillCam COLON capsule, (8) protection and validity of patents and other intellectual property rights, (9) the impact of currency exchange rates, (10) the effect of competition by other companies, (11) the outcome of significant litigation, (12) our ability to obtain reimbursement for our product from government and commercial payors, (13) quarterly variations in operating results, (14) the possibility of armed conflict or civil or military unrest in Israel, (15) the impact of global economic conditions, (16) our ability to successfully integrate acquired businesses, (17) changes and reforms in applicable healthcare laws and regulations, (18) quality issues and adverse events related to our products, such as capsule retention, aspiration and failure to attach or detach, bleeding or perforation that could require us to recall products and impact our sales and net income, and (19) 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, 2011. 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 to the extent expressly required under applicable law, the Company undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

(1) http://www.agmd-gimotility.org/about_motility.htm

(2) http://www.iffgd.org/site/gi-disorders/adults/motility-disorders

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