Healthcare Industry News:  Capsule Endoscopy 

Devices Gastroenterology

 News Release - May 20, 2009

Given Imaging Announces One Millionth PillCam(R) Video Capsule

Patient-Friendly, PillCam(R) Capsule Endoscopy Now an Essential Diagnostic and Monitoring Tool for Detecting Diseases of the GI Tract

YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--May 20, 2009 -- Given Imaging LTD. (NasdaqGM:GIVN ) today announced that one million PillCam® video capsules have helped physicians evaluate patients for GI disorders since the company introduced the fundamentally new approach to examining the gastrointestinal tract in 2001. The patient-friendly PillCam® SB has rapidly become the gold-standard tool to help physicians examine the entire length of the small bowel to diagnose disorders such as obscure gastrointestinal bleeding (OGIB), Crohn's disease, celiac disease, tumors and a range of other small bowel disorders. Prior to PillCam Capsule Endoscopy, exploratory surgery was the only available method for visualizing the entire small intestine.

"From the start, it was clear that the PillCam SB video capsule was going to allow us to see more of the GI tract so that we could make definitive diagnoses and treat patients sooner without putting them through invasive surgery," said Blair S. Lewis, MD, Mt. Sinai Medical Center, New York. "First used in obscure GI bleeding, PillCam SB is now used to evaluate a range of small bowel disorders, backed by evidence generated in more than 1,000 peer-reviewed publications. Through these studies, we continue to advance our understanding of small bowel disease, which in turn has benefited 1,000,000 patients."

The first innovation in gastrointestinal endoscopy in nearly 10 years, PillCam video capsules provided physicians with a tool to image the entire small bowel via a camera in a vitamin-sized pill that a patient easily swallows. Unlike other diagnostic procedures for the GI tract, PillCam video capsules require no sedation and allow the patient to carry on with normal daily activities. Committed to expanding disease applications through new product introductions and extensive clinical research, Given introduced the PillCam ESO in 2004, the Agile patency capsule and the PillCam COLON capsule in 2006 [PillCam COLON not available for sale in the US] and acquired the Bravo pH monitoring device in 2008.

Since introducing the world to PillCam Capsule Endoscopy in 2001, Given Imaging has:

-- Brought PillCam endoscopy to more than 70 countries worldwide;

-- Installed PillCam platform at more than 5,000 centers worldwide;

-- Achieved reimbursement for PillCam SB for nearly 580 million lives worldwide

-- Introduced technology for visualizing esophagus and colon, PillCam ESO and PillCam COLON [PillCam COLON not available for sale in the US];

-- Offered continuous innovation and product advancements for superior visualization and maximum workflow productivity.

-- Offered educational seminars to the majority of our customers annually

-- Built the third-largest US sales force in field of GI; and

-- Achieved profitability and maintained a strong cash position.

"PillCam endoscopy helped my physician to find a serious problem in my small intestine. Previous tests had all been negative," said Michael Polimeni, a 49-year-old patient of Dr. Lewis. "As a patient who has undergone several GI procedures over the last several years, I was pleasantly surprised when I found out how easy PillCam endoscopy was."

The PillCam SB video capsule measures 11 mm x 26 mm and weighs less than four grams. It contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures over an eight-hour period.

"We are proud to have made a difference in the lives of so many patients and we remain committed to providing physicians with innovative and patient-friendly diagnostic and monitoring tools for the GI tract," said Homi Shamir, President and Chief Executive Officer, Given Imaging. "Our vision for the future is to employ our leadership in state-of-the-art software and imaging technology to create products that enable earlier detection of GI disorders in order to ultimately save lives and improve patient care."

The company continues to innovate and improve the diagnostic experience for health care providers and patients alike, and plans to introduce several procedural improvements at upcoming annual meetings for the Society for Gastroenterological Nurses Association and at Digestive Disease Week, which take place from May 15 - 20 and May 31 - June 3, respectively.

About Given Imaging

Since 2001 Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam Capsule Endoscopy provides physicians with natural images of the small intestine via PillCam SB, the esophagus through PillCam ESO and the colon with PillCam COLON [not cleared for use in the USA]. The PillCam capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile(TM) patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). Given Imaging's products use cutting-edge wireless technology and advanced software to enable gastroenterologists to better diagnose and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia and Singapore. For more information, please visit http://www.givenimaging.com.

Forward-Looking Statements

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) our ability to develop and bring to market new products, (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 significant litigation, (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, (11) the impact of global economic conditions, 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, 2008. 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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