New Studies Show Given Imaging's SmartPill(R) Provides Standardized And Comprehensive Evaluation In Patients With Gastrointestinal Motility Disorders

SAN DIEGO, Oct. 14, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results from two new studies that provide new information about gastroparesis, constipation and small intestinal bacterial overgrowth when using its SmartPill product. The studies were presented by researchers from the Cleveland Clinic and Texas Tech University Health Sciences Center at the American College of Gastroenterology's 2013 Annual Scientific Meeting (ACG) taking place October 11-16, 2013 in San Diego, California.

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. 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 for evaluation by a physician.

"SmartPill provides clinicians with a powerful tool that helps us measure GI tract transit in patients who we cannot otherwise evaluate," said Zubin Arora M.D., Cleveland Clinic. "In our study, SmartPill revealed that many patients with symptoms suggestive of gastroparesis or constipation actually have more generalized gut dysmotility which definitely has implications for how we manage these patients therapeutically."
  • "Clinical Utility and Diagnostic Yield of 165 Wireless Capsule Studies at a Tertiary Referral Center," poster 1684: presented by Zubin Arora, M.D., and colleagues from the Cleveland Clinic, is a retrospective study of 165 patients with suspected motility disorders who underwent SmartPill studies. SmartPill provided the researchers with new information about bowel transit time that could aid patient management. In the study, SmartPill revealed abnormal findings in 78% of patients, including delayed large bowel transit time (39%), delayed gastric emptying time (35%) and delayed small bowel transit time (29%). In patients who received SmartPill for evaluation of gastroparesis, small bowel transit time was delayed in 39% of patients, and large bowel transit time was delayed in 28% of patients. Similarly, in patients who received a SmartPill test for evaluation of constipation, gastric emptying time was delayed in 27% of patients, and small bowel transit time was delayed in 25% of patients. 25% of patients suspected to have both gastroparesis and constipation had abnormal small bowel transit time. A large number of patients with abnormal gastric emptying scintigraphy also had abnormal small bowel transit time (36%) and large bowel transit time (41%). Similarly, many patients with abnormal Sitzmarks studies also had delayed gastric emptying time (50%) and delayed small bowel transit time (15%).    
  • "Does Small Intestinal Bacterial Overgrowth Delay Small Bowel Transit Time?," poster 767: presented by Irene Sarosiek, M.D., and colleagues from Texas Tech University, the investigators used SmartPill to explore the theory that symptoms of chronic idiopathic constipation may be related to alterations and abnormal colonization within the gut microbiata resulting in small intestinal bacterial overgrowth. The study found that small bowel transit time was 20% slower in patients with small intestinal bacterial overgrowth. After two weeks of treating the patients' constipation with lubiprostone, 37% no longer had small intestinal bacterial overgrowth and their small bowel transit time was reduced by 21%.

About SmartPill® motility monitoring systems

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 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 monitoring, and SmartPill ® motility 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 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 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: Chantal Beaudry/Martyna Gawrych         Lazar Partners Ltd.         cbeaudry@lazarpartners.com         mgawrych@lazarpartners.com         212-867-1762                  Investor Contact:         David Carey         Lazar Partners Ltd.         dcarey@lazarpartners.com         212-867-1762                  Israel Investor Contact:         Nava Ladin         Gelbart Kahana Investor Relations         +972-3-6074717         nava@gk-biz.com

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