BERLIN, Oct. 16, 2013 (GLOBE NEWSWIRE) -- Given Imaging (Nasdaq:GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced numerous studies confirming the value of its reflux and manometry products in diagnosing, monitoring and managing a range of gastrointestinal diseases. The studies were presented at United European Gastroenterology Week (UEG Week), taking place from October 12-16, 2013 at the Internationales Congress Centrum Berlin where Given Imaging is exhibiting at Hall 15.1, Booth #7 throughout the conference. Results of more than 110 clinical studies of Given Imaging's products were presented at UEG Week this year demonstrating the breadth and utility of its portfolio. "New tools like high-resolution manometry and prolonged pH monitoring deliver more detailed and more relevant information that allow us to explain the causes of patient symptoms and to better manage patients with esophageal disorders," said Mark Fox, M.D., Division of Gastroenterology of University Hospital Zurich. "It is important that we continue to use these tools to select the most appropriate pharmacologic as well as surgical therapies." Key Given Imaging highlights include the following studies at UEG Week: pH and pH-Impedance Monitoring
- "Understanding the Cause of Persistent GERD Symptoms Despite Proton Pump Inhibitor Therapy: Impedance-pH Monitoring Revisited" (poster 460) : Daphne Ang M.D., Changi General Hospital, Department of Gastroenterology, Singapore, presented data on use of impedance-pH testing showing that both acid reflux and non-acid reflux events account for persistent symptoms in PPI (proton pump inhibitors) non-responders, especially patients with typical reflux symptoms. Authors noted that therapies beyond PPI may be necessary.
- "The Real Prevalence of Functional Heartburn: The Lesson of Prolonged Wireless pH Monitoring" (poster 1598): Roberto Penagini M.D. of the Cattedra di Gastroenterologia, Università degli Studi and Fondazione IRCCS, Ospedale Maggiore, Mangiagalli e Regina Elena, Milan, Italy, presented a study showing how use of either a 48-hr catheter or 48 to 96-hr wireless study can provide a more accurate diagnosis of functional heartburn than standard of care. Functional heartburn is diagnosed in patients with heartburn refractory to PPIs when endoscopy, esophageal acid exposure time (AET), and symptom index (SI) are negative. Diagnosing functional heartburn is important as it often leads to a change in the way patients are managed.
- "Assessment of Patients Referred for GERD Evaluation: To Continue or Stop Acid Suppressants Before Functional Tests? " (oral presentation 379): Presenter Daphne Ang M.D., of Changi General Hospital, Department of Gastroenterology, Singapore, showed data from a study involving 2925 patients that aimed to determine the diagnostic yield of functional studies performed on and off proton pump inhibitor (PPI) therapy. Investigators concluded that among those GERD patients with insufficient treatment response, improved diagnostic yield was achieved with multichannel intraluminal impedance-wireless pH monitoring performed on PPI therapy for evaluation of non-acid reflux and off therapy for acid reflux evaluation.
- "Esophageal Work-Up Prior to Bariatric Surgery: Who and How to Investigate?" (poster 1599): Benjamin Heimgartner, M.D., Inselspital, Bern University Hospital, Gastroenterology and Hepatology, Bern, Switzerland, presented data from this study that examined the optimal diagnostic work-up in an obese patient population. Results showed that reflux monitoring is superior to endoscopy in detecting GERD, yet a substantial number of patients with erosive esophagitis had "normal" esophageal acid exposure. Since typical reflux symptoms do not predict the presence of esophagitis and abnormal acid exposure, the study investigators recommend including endoscopy and reflux monitoring as part of the pre-operative work-up prior to bariatric surgery.
- "Long Term Outcome of Patients with Reflux Symptoms and Symptomatic Esophageal Dysfunction During and After a Standardized Test Meal: A High-Resolution Manometry Study " (poster 1587): Mark Fox M.D., Nottingham University Hospital NIHR Digestive Disease BRU, United Kingdom, presented results from a study to assess esophageal function and symptoms using high resolution manometry (HRM) with 5ml water and a test meal followed by 10min post-meal observation of symptoms and events. HRM studies which include a test meal and post-meal observation provide an objective explanation for symptoms in the majority of patients investigated for reflux symptoms. Long-term follow-up suggests this information can guide management.
- " Prevalence of Relaxation Disorders of the Lower Esophageal Sphincter in Patients Undergoing High Resolution Manometry" (poster 1585): Presented byJutta Keller M.D., Israelitisches Krankenhaus Internal Medicine, Hamburg, Germany, this study used esophageal manometry to determine the integrated relaxation pressure (IRP) according to the Chicago Classification in 787 patients. Results showed that LES (lower esophageal sphincter)-relaxation occurred in more than 10% of patients undergoing high resolution manometry.
- " Factors that Affect the Disruption of Esophagogastric Junction and its Relation with High Resolution Manometry Alterations and Acidic Reflux" (poster 1007): Constanza Ciriza de Los Rios M.D. of the Hospital 12 de Octubre, Dept. de Gastroenterologia, Madrid, Spain, presented data from a study of 115 patients evaluating the risk factors associated with esophagogastric junction disruption (EGJ) and the relationship between esophagogastric junction type, manometric alterations and acid reflux. The study results indicated that high resolution manometry (HRM) facilitates the investigation of the OGJ and its progressive disruption showing that age, weight and central obesity pose a greater risk for hiatus hernia. Greater EGJ disruption is associated with lower pressure, esophageal shortening, and higher acid exposure in pH-metry.
About ManoScan high resolution manometryGiven Imaging pioneered ManoScan high resolution manometry, the first high resolution manometry system. ManoScan system continues to remain the market leader in comprehensive solutions for assessing gastrointestinal motility. ManoScan is the only system with automatic findings incorporated into the Chicago Classification algorithms, a standardized categorization system for identifying and classifying motility disorders. Through the combination of proprietary tactile-sensing catheter technology and easy-to-use ManoView ® software, ManoScan reveals complex functional anatomy, enabling physicians to more accurately diagnose abnormalities of the gastrointestinal tract. Manometry products have certain risks associated with catheter insertion. Medical, endoscopic or surgical intervention may be necessary to address complications, should they occur. These systems are not compatible for use in an MRI magnetic field. About Bravo pH monitoring Bravo pH monitoring is the only catheter-free pH test. The procedure uses a pH capsule that is temporarily attached to the wall of the esophagus to wirelessly transmit pH data continuously for up to 96 hours. Like catheter-based pH tests, the Bravo pH monitoring system is an ambulatory method of pH monitoring, considered the gold standard for pH measurement and monitoring of gastric reflux. The Bravo pH monitoring system collects data that are more reflective of the patient's normal daily routine to assess if the patient has GERD. The risks of Bravo pH monitoring include: premature detachment, discomfort, failure to detach, failure to attach, capsule aspiration, capsule retention, tears in the mucosa, bleeding, and perforation. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. Because the capsule contains a small magnet, patients should not have an MRI study within 30 days of undergoing the Bravo pH test. 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: For further information contact: Chantal Beaudry/Martyna Gawrych Lazar Partners Ltd. firstname.lastname@example.org email@example.com 212-867-1762 Investor Contact: David Carey Lazar Partners Ltd. firstname.lastname@example.org 212-867-1762 Israel Investor Contact: Nava Ladin Gelbart Kahana Investor Relations +972-3-6074717 email@example.com