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Given Imaging Announces New Data Confirming SmartPill(R) Improves Diagnosis and Clinical Management of Patients With Motility Issues

ORLANDO, Fla., May 20, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced several studies confirming an expanded role for SmartPill in diagnosing gastrointestinal motility disorders. All data were presented at Digestive Disease Week® (DDW) taking place May 18 - 21, 2013 at the Orange County Convention Center, Orlando, FL where Given Imaging is exhibiting at booth #1059 throughout the conference.

"The SmartPill motility monitoring system gives us a complete GI profile that allows us to recognize multiregional transit irregularities in patients with possible upper or lower GI dysmotility," said Braden Kuo, M.D., Director, Gastrointestinal Motility Laboratory, Massachusetts General Hospital. "These new studies add to the growing body of data showing that SmartPill is an extremely valuable tool enabling us to diagnose and treat motility disorders for better patient care."

A key poster presentation, Wireless Motility Capsule Alters Diagnosis and Affects Clinical Management in Patients with Suspected Gastrointestinal Dysmotility, poster Mo2092, presented by Shreya Raja, M.D., Division of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, and colleagues, retrospectively examined how SmartPill findings affect clinical care. The study reviewed numerous data points including pressure, pH and temperature data collected by SmartPill to determine the diagnostic yield of wireless motility capsule and assess changes in 51 consecutive patients with suspected dysmotility. Clinical management decisions after the SmartPill procedure, including medication changes, referrals for additional diagnostic tests, and outside referrals, were also analyzed. Results show that data collected by SmartPill impacts patient care by altering diagnosis and clinical management. Alteration in diagnosis was frequent and change in medication was made for the majority of patients with abnormal testing results. Furthermore, normal SmartPill testing changed clinical management in over 50% of cases.

Several additional studies presented during DDW highlight the value of SmartPill for the evaluation and diagnosis of different motility conditions. Studies include:

  • Potential Role for Ileocecal Valve Dysfunction and Small Intestinal Dysmotility in Bacterial Overgrowth As Assessed by Wireless Motility Capsule, poster Mo2059, presented by Bani Chander Roland, M.D., Department of Internal Medicine, Johns Hopkins School of Medicine, and colleagues, assessed the relationship of ileocecal valve (ICV) pressures with lactulose breath test (LBT) results, characterized the relationship of prolonged small bowel transit time (SMTT) with LBT, and assessed the relationship of gastric/small bowel pH and pressures with LBT using SmartPill testing. Results show that low ICV pressures are significantly associated with small intestinal bacterial overgrowth (SIBO). Furthermore, prolonged SBTT is also highly associated with SIBO. There is no association between delayed SBTT and low ICV pressure, suggesting that these mechanisms independently contribute to SIBO. These findings may help clarify SIBO pathogenesis and lead to more patient-specific treatment strategies.
  • Use of Additional Wireless Motility Capsule (WMC) Parameters Improves Gastrointestinal Landmark Identification, poster Mo2104, presented by Sonia Yoon, M.D., GI Medicine, Massachusetts General Hospital, and colleagues, sought to identify gastric emptying (GET), and small bowel (ICJ) and colonic transit times by pH alone and to determine if utilization of SmartPill motility monitoring which include other parameters could increase the yield and precision in determining GI transit landmarks. The results of 168 patients showed that SmartPill analysis using the additional parameters such as frequency and amplitude, FFT analysis and temperature increases the yield for landmark identification compared to pH alone.
  • Small Intestinal Transit Time Is Prolonged in Patients with Small Intestinal Bacterial Overgrowth, poster Mo2068, presented by Bani Chander Roland, M.D., Department of Internal Medicine, Johns Hopkins School of Medicine, and colleagues, analyzed the relationship of prolonged small bowel transit time (SBTT) in patients undergoing SmartPill motility monitoring with positive lactulose breath test (LBT) and to assess the relationship of prolonged gastric, colonic and whole gut transit times with positive LBT. The retrospective study looked at 72 consecutive patients who were referred for motility testing with 37 patients who underwent both SmartPill and LBT. Results showed that patients with underlying small intestinal bacterial overgrowth have significant delays in SBTT as compared to those without. The correlation between prolonged SBTT and positive LBT may be useful in identifying those patients with underlying SIBO and could suggest therapeutic options for those refractory to standard therapy.

About SmartPill® motility monitoring system

The SmartPill motility monitoring system offers a unique way to assess motility by collecting and analyzing data from within the entire GI tract via a test that can be performed in the clinic or physician's office. The test is ambulatory, allowing the patient to go about their normal routine throughout the test. As the SmartPill capsule passes through the GI tract, it transmits data to a recorder worn by the patient. Once the single-use capsule has passed from the body, study data are downloaded from the recorder to a computer. The physician then uses MotiliGI® software to display and analyze the data, providing test results in both graphical and report formats. Results are used for the evaluation of gastroparesis and chronic constipation. The SmartPill motility monitoring system was granted initial 510(k) release from the U.S. Food and Drug Administration (FDA) in July 2006.

SmartPill may not be a solution for every type of patient and is not indicated for children under the age of 18. The risks of SmartPill motility monitoring include capsule retention and aspiration. Patients should not have an MRI while SmartPill is in their body.

About Digestive Disease Week®

Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

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 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. 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, 2012. 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.

CONTACT: For further information contact: Chantal Beaudry/Martyna Gawrych Lazar Partners Ltd. cbeaudry@lazarpartners.com mgawrych@lazarpartners.com 212-867-1762 Israel Investor Contact: Nava Ladin Gelbart Kahana Investor Relations +972-3-6074717 nava@gk-biz.comSource:Given Imaging Ltd.