Given Imaging Announces Results From Multiple PillCam(R) COLON Studies Presented at UEGW 2011

STOCKHOLM, SWEDEN--(Marketwire - Oct 25, 2011) - Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and the capsule endoscopy pioneer, announced today that data from multiple clinical studies on its PillCam^® COLON capsule were presented at the United European Gastroenterology Week (UEGW), Europe's largest gastroenterology conference, in Stockholm, Sweden, from October 22nd - 26th. Given Imaging is exhibiting at booth A08:30 throughout the conference.

In an oral presentation (OP057) yesterday, Dr. Cristiano Spada, of the Digestive Endoscopy Unit, Catholic University, Rome, presented the "First Guidelines to Implement and Practice Colon Capsule Endoscopy (CCE) in a Clinical Setting," which were endorsed by the European Society for Gastrointestinal Endoscopy and prepared in alignment with the ESGE methodology. A panel of 31 GI experts convened to evaluate 17 papers, resulting in 16 statements that form a comprehensive framework on how to implement colon capsule endoscopy in daily practice. The statements are focused around (1) indications/contraindications, (2) bowel preparation, (3) report/work-up and (4) technique. PillCam COLON consensus guidelines have been submitted for peer review publication.

"Numerous studies have shown PillCam COLON capsule endoscopy to be an innovative, non-invasive technique to visualize the colon," said Dr. Spada. "We developed these guidelines to provide guidance to the international medical community on how to integrate colon capsule endoscopy appropriately in their practices."

Poster Presentations of PillCam COLON Studies

Clinicians presented new data on the clinical indications for PillCam COLON capsule endoscopy in four additional poster presentations:

• A poster (P0123) "Evaluation of Detectability for Flat Tumors Using Colon Capsule Endoscopy," by Dr. Y. Kakugawa of the National Cancer Center in Tokyo, Japan, determined that using colon capsule endoscopy with adequate bowel preparation and careful video reading by an expert successfully detected most flat colorectal lesions. Flat lesions are often difficult to detect by conventional colonoscopy due to the insufflation of the colon.
  
  
• In a second poster presentation, (P1062) "The Use Of PillCam COLON In Assessing Mucosal Inflammation In Ulcerative Colitis: A Multi-Center Study," Dr. J.J. Sung of the Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China, and colleagues completed a 100 patient multicenter study to examine whether colon capsule endoscopy (CCE) can be used to differentiate between active and inactive ulcerative colitis (UC) based on mucosal appearance. The sensitivity of CCE to detect active colonic inflammation was 89% (95% CI 85% > 93%) and specificity was 75% (95% CI 57% > 87%).The positive predictive value and negative predictive value of CCE for colonic inflammation were 93% and 65%, respectively. Investigators found CCE to be a safe procedure with promising accuracy in the detection of colonic inflammation in UC.
  
  
• Another poster, (P1152) "Colon Capsule Endoscopy Compared to Colonoscopy for Familial Screening of Colorectal Cancer," Dr. M. Alvarez, Gastroenterology Department, Hospital Del Mar, Barcelona, Spain, and colleagues sought to assess the diagnostic yield of capsule endoscopy in patients at high risk for colorectal cancer (CRC) compared to colonoscopy and to evaluate colon cleanliness with the colon preparation Moviprep. Capsule endoscopy and colonoscopy were performed on the same day by endoscopists blinded to each other. All of the 41 patients enrolled had a first-degree relative with CRC diagnosed before age 60, or two or more first or second-degree relatives with CRC diagnosed at any age. The authors confirmed that the overall cleanliness achieved with Moviprep is acceptable (77.5%), and the regimen is very well tolerated by patients, concluding that capsule endoscopy is an accurate and safe alternative procedure for familial CRC screening.
  
  
• In a fourth poster, (P0534), "Capsule Colonoscopy with PillCam COLON 2 Is Feasible as an Outpatient Procedure," led by Dr. Samuel Adler, Gastroenterology Department, Bikur Holim Hospital, Israel, investigated the feasibility of performing colon capsule endoscopy in an outpatient setting. The study used the same inclusion and exclusion criteria as well as the bowel preparation of prior published multicenter studies and employed the new data recorder (DR3) that alerts the patient when to ingest the additional laxative booster required in the PillCam regimen. Fifteen minutes after ingesting the PillCam COLON capsule, patients left the clinic. The DR3 began providing auto procedure alerts in timely intervals, except for in the case of one patient, who inadvertently activated the data recorder and received a false message. Of the 28 patients enrolled, findings were present in 20/28 (71%) patients. Five patients subsequently underwent colonoscopy which confirmed the findings, including one colon carcinoma. The pilot study authors concluded that PillCam COLON 2 could be performed as an outpatient medically supervised procedure.
  
  

About Colorectal Polyps

There are two common types of colorectal polyps: adenomatous, which can develop into cancer, and hyperplastic, which are rarely more than 5 mm in size and are infrequently cancerous.¹ For adenomas, the potential for malignancy is related to polyp size.² Larger polyps are more likely to develop into cancer, and polyps that are over 2 cm in size may potentially contain cancer.³

About Colon Cancer

Colon cancer involves the large intestine (colon), the lower part of the digestive tract, while rectal cancer specifically involves the last 6 inches of the colon. Together, they're often referred to as colorectal cancers. Colon and rectal cancers begin in the digestive tract and occur when cells that line the colon or the rectum become abnormal and grow uncontrollably. Despite widespread public education efforts, colorectal cancer screening compliance rates remain low, with just 50% of the eligible US population undergoing a colonoscopy⁴. About 147,000 people in the U.S. are diagnosed with colorectal cancer annually, according to the National Cancer Institute⁵. Worldwide, the disease causes 1 million cases and 600,000 deaths every year, with lower CRC screening compliance in Europe and Japan.

About PillCam COLON 2

The PillCam^® COLON 2 video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 mm. PillCam COLON 2 is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.

All medical procedures carry some risk. The risks of PillCam^® capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON capsule endoscopy presents additional risks, including risks associated with the drug products used to prepare the patient for the procedure, which are currently used for colonoscopy, and to move the capsule through the patient's digestive tract faster. It may also present other risks that are unknown, but which the clinical studies are designed to detect. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

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® video capsules for the small bowel, esophagus and colon [PillCam® COLON not approved for use in the United States.], industry-leading ManoScan™ high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products. 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 and Hong Kong. For more information, please visit 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 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) product quality issues that could require us to recall products and impact our sales, 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, 2010. 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

¹ http://www.mayoclinic.com/health/colon-polyps/DS00511/DSECTION=causes
² http://emedicine.medscape.com/article/367452-overview
³ http://www.asge.org/PatientInfoIndex.aspx?id=396
⁴ http://www.cdc.gov/cancer/colorectal/statistics/screening_rates.htm
⁵ http://seer.cancer.gov/statfacts/html/colorect.html