SOURCE: Given Imaging

Given Imaging

May 20, 2012 13:30 ET

New Studies Confirm Value of Given Imaging's Advanced Esophageal Diagnostics Products in Diagnosing and Monitoring Esophageal Disorders

Data Show That Capsule Endoscopy Correlates With Gastroscopy Findings; Study Shows That Bravo pH Monitoring Can Be Successfully Extended in Most Cases

SAN DIEGO, CA--(Marketwire - May 20, 2012) - Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that new studies confirm the value of its PillCam® ESO as a tool to help triage patients with upper gastrointestinal bleeding (UGIB) and show that PillCam ESO can detect lesions that traditional gastroscopy has missed.

An additional new study shows that Bravo® pH monitoring for patients with gastroesophageal reflux disease (GERD) can be extended to four days to increase findings. This longer duration will result in more meaningful feedback regarding patients' conditions and how they are affected by daily activities, allowing doctors to work with patients to adjust their diet and drug regimens. The data from these studies were presented at Digestive Disease Week® (DDW), being held from May 19-22, 2012, in San Diego.

"These new studies confirm the clinical efficacy of PillCam ESO and Bravo pH monitoring in diagnosing, monitoring, and triaging a variety of esophageal disorders," said David Mason, MD, Chief Medical Officer at Given Imaging. "PillCam ESO has been shown to be useful in detecting lesions which if not quickly found could result in serious or fatal bleeding in the upper GI tract and in detecting lesions that gastroscopy was not able to pick up. Additionally, Bravo pH monitoring helped to successfully monitor and stratify cases of gastroesophageal reflux disease (GERD)."

Three key poster presentations were presented on PillCam ESO and Bravo pH monitoring:

  • Sujievvan Chandran, MD, Gastroenterology, Austin Health, Melbourne, VIC, Australia, and colleagues, presented results of a diagnostic, non-randomized, single blind study (abstract Sa1726) of 83 patients with acute UGIB. They found that PillCam ESO capsule study findings correlated well with gastroscopy findings and correctly identified 85 percent of patients who could have been managed as outpatients. Additionally, 8 percent of the total patient population had lesions that PillCam ESO detected that gastroscopy missed.

  • Gabriela I. Escobar, MD, Northwestern University, and colleagues, presented results of a study (abstract Su1100) of 100 GERD patients who continued to suffer symptoms despite taking proton pump inhibitor (PPI) drugs to inhibit acid reflux. The patients underwent a four day Bravo pH monitoring study. The Bravo pH studies were successfully extended to four days in 84 percent of instances, and extending the duration of the studies allowed doctors to stratify GERD based on frequency of positive days, which may help physicians more accurately identify the patients who could benefit from chronic PPI therapy or anti-reflux surgery.

  • Yinglian Xiao, MD, Gastroenterology, Northwestern University, and colleagues, presented results of a study (abstract Sa1352) comparing high resolution manometry (HRM) (manometry assesses motor function in the esophagus) variables in 4 phenotypes of 192 PPI non-responders (PPINR). The study concluded that PPINR phenotypes defined by pH-impedance were not associated with significant differences in motor function on HRM, suggesting that categorization of PPINR phenotypes should include measures beyond reflux parameters and motor function.

Additional studies were presented that used Given Imaging's manometry and reflux products:

  • Abhinav Sankineni, Gastroenterology, Temple University Hospital, Philadelphia, PA, and colleagues, presented a study (abstract Sa1196) that aimed to describe the characteristics of patients with slow propagation velocity (SPV) on high resolution esophageal manometry (HREM). A retrospective review of a prospectively obtained database of patients undergoing HREM (ManoScan, Given Imaging, Ltd.) between November 15, 2010 and November 15, 2011 was conducted at Temple University Hospital. The study concluded that patients with slow esophageal propagation velocity have a higher prevalence of dysphagia for solids and nausea when compared to normal propagation velocity (NPV). Thus, both slow and rapid esophageal propagation velocity are associated with dysphagia.

  • Junichi Akiyama, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, and colleagues, presented a study (abstract Sa1199) which aimed to evaluate the impact of EGJ and/or peristaltic dysfunction on symptoms and transit as measured by radionuclide esophageal transit scintigraphy (RETS). The investigators conducted a retrospective study of three hundred forty one patients who underwent HRM (ManoScan, Given Imaging, Ltd.) between Jan 2010 to Sep 2011. The study concluded that impaired EGJ relaxation or esophageal peristaltic dysfunction determined by HRM correlate with impaired bolus transit as measured by RETS.

  • Mark R. Fox, NIHR BRU, Nottingham Digestive Disease Centre, University of Nottingham, Nottingham, United Kingdom, and colleagues presented a study (abstract 1137a) reporting inter-observer agreement for classification of individual HRM/EPT water swallows (study A) and diagnoses based on 10 swallows (study B) using the HRM Working Group's new classification system for esophageal motility disorders using HRM / EPT (Pandolfino, NGM 2009). The on-line study, the largest assessment of inter-observer agreement performed for manometric studies, found that overall inter-observer agreement for HRM/EPT of individual swallows and diagnostic studies was fair to moderate, increasing with experience of this technology and the classification system. Analysis of swallows with low agreement indicates that "pattern recognition" of HRM/EPT data was not adequate and highlighted the value of objective metrics in the diagnosis of esophageal dysmotility.

About the Bravo® pH Monitoring System
The Bravo® pH monitoring system 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 PillCam® ESO
The PillCam® ESO video capsule was cleared by the U.S. Food and Drug Administration in patients eighteen years and older to visualize the esophagus. Now in its third generation, PillCam ESO 3 contains imaging devices and light sources at both ends of the capsule to capture 35 images per second as it passes down the esophagus in a patient-friendly thirty-minute procedure.

All medical procedures carry some risks. The risks of PillCam capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the PillCam patency capsule include capsule retention and aspiration. After ingesting the PillCam capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created by an MRI device. Endoscopic placement may present additional risks. 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® pH and Digitrapper® pH and impedance monitoring. 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.

About 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, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19 - 22, 2012, at the San Diego Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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) 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, 2011. 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) National Institute of Diabetes and Digestive and Kidney Diseases (niddk.nih.gov)

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