SOURCE: Given Imaging

Given Imaging

May 09, 2011 07:00 ET

Given Imaging Announces New Data on the Benefits of Using Bravo® Wireless pH Monitoring to Manage GERD

Additional Study Examines the Value of Proton Pump Inhibitor Therapy Following Negative pH-Impedance Test Results

CHICAGO, IL--(Marketwire - May 9, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the results of two new studies indicating that physicians should analyze pH levels of patients with gastroesophageal reflux disease (GERD) for periods of 48 hours or longer to strengthen symptom correlation and improve diagnostic accuracy. The Company also announced the results of a study highlighting the unnecessary continued use of proton pump inhibitors (PPIs) after negative pH-impedance testing with Given Imaging's Digitrapper® pH-Z Monitoring System. All four studies were presented at Digestive Disease Week (DDW) 2011, in Chicago, McCormick Place, May 7-10.

"Reflux events and symptoms vary day-to-day and are greatly affected by patient behavior, such as exercise and eating. Therefore, it is often advisable to monitor GERD patients for at least 48 hours to have an accurate understanding of the severity of disease and the cause of their symptoms," said Mark Fox, Clinical Associate Professor at the Nottingham Digestive Diseases Centre, United Kingdom. "The longer we study these patients, the more reliable and consistent data we are able to gather, enhancing our ability to diagnose and manage their condition."

In Dr. Mark Fox's study, abstract Sa1181, 163 patients underwent a 96-hour Bravo recording, followed by an evaluation of the measured acid exposure time, symptom index and symptom association probability, at 24-hour intervals to determine the measurement consistency of 96-hour ambulatory reflux monitoring. The study authors concluded that increasing the duration of reflux studies greatly improved the consistency of GERD diagnosis based on pH monitoring. Dr. Fox also led a podium presentation, abstract #499, on "Symptom Association in Ambulatory Gastro-Esophageal Reflux Monitoring: A Systematic Review". Researchers analyzed data recordings from the Bravo pH Monitoring System and corresponding symptom diaries of the 163 patients using the authors' custom written software. Their systematic analysis demonstrated that a threshold for reflux detection of pH4.5 and a time window of 1 minute were optimal for reflux-symptom association. Another study, abstract Sa1199, compared 48-hour Bravo recordings with 24-hour catheter-based recordings and scores at day one vs. day two vs. total in a retrospective chart review of 124 patients. The researchers concluded that 48-hour pH monitoring strengthens symptom correlation as compared to 24-hour results. Further, they suggested that 48-hour Bravo studies should be performed as standard of practice.

Separately, an additional study, abstract #497, looked at the correlation of pH-impedance (MII-pH) results using Given Imaging's Digitrapper® pH-Z Monitoring System and patient use of PPIs to manage their symptoms.

Jami Rothe, of the University of Chicago, led a podium presentation on the results of abstract #497. The study analyzed the results of a phone survey of 87 patients whose MII-pH tests had ruled out GERD, and found that many had continued PPI therapy. The researchers highlighted a correlation between patients who continue PPI therapy without a definitive GERD diagnosis and an increase in the likelihood to have symptoms of anxiety or pain. The study authors emphasized the need for improved strategies to better identify the cause of patient symptoms as well as alternative treatment options for patients who do not experience symptom relief from PPIs.

About GERD
Gastroesophageal reflux (also known as heartburn) occurs when contents from the stomach flow back up into the esophagus. Occasional heartburn related to these events is normal, but chronic heartburn caused by GERD can affect daily activities and damage the esophagus. Left untreated, GERD may also lead to more serious medical problems:

  • Difficulty swallowing (dysphagia)
  • Painful swallowing (odynophagia)
  • Narrowing of the esophagus (strictures)
  • Barrett's esophagus (pre-cancerous lesion)
  • Chronic hoarseness or laryngitis
  • Respiratory problems (coughing, asthma)

Symptoms of GERD can be seen in two to eight percent of children aged three to nine years and in five percent of adolescents1. GERD symptoms in children are similar to those experienced by adults, such as heartburn, acid regurgitation, excessive belching, and dysphagia; however presentation may be less obvious with abdominal pain and failure to thrive as the only sign of disease. Gastroesophageal reflux disease in children and adolescents is often managed through lifestyle changes, the introduction of medications which decrease gastric acid, and in rare circumstances surgery is needed.

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. DDW is 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. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

About the Bravo pH Monitoring System
The Bravo® pH Monitoring System is the only catheter-free pH test. The procedure uses a capsule that collects and transmits pH data via radio frequency telemetry to a small, external, pager-sized receiver worn by the patient. 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 Bravo system allows patients to maintain their regular diet and activities. The Bravo system also minimizes throat and nasal discomfort associated with conventional catheter-based pH systems. With little visible indication that a pH test is taking place, Bravo pH monitoring eliminates the social embarrassment that accompanies traditional pH testing. The Bravo pH Monitoring System extends pH data collection to 48 hours or more than twice the recording capability of conventional catheter systems. Bravo provides physicians with additional data needed for an accurate GERD assessment. Current studies show that Bravo increases the likelihood of GERD diagnosis based on acid exposure and confirms that prolonged 48-hour monitoring facilitates the documentation of relationships between symptoms and reflux events, as reported first in a 2003 study published in The American Journal of Gastroenterology2. The Bravo system is the subject of more than 50 peer-reviewed and industry publications.

Traditional pH testing studies, sometimes combined with impedance measurement, involve the insertion of a very small catheter into the nostril and advancing it into the esophagus, where it stays throughout the 24-hour testing period. Patients using the catheter method often do not follow their usual daily schedule so the pH measurements may not be predictive of GERD during the 24-hour testing period. Challenges to traditional catheter-based pH testing include throat irritation, difficulty sleeping and discomfort during eating and drinking.

All medical procedures carry some risks. Bravo® pH monitoring risks include: premature detachment, discomfort, failure to detach, tears in the mucosa, bleeding, and perforation. Endoscopic or transnasal placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

About the Digitrapper pH-Z Monitoring System
The Digitrapper® pH-Z Monitoring System includes AccuView™ analysis software, which presents study data in a clear, anatomically-oriented fashion and rapidly generates reports using advanced analysis methods. The Digitrapper pH-Z recorder is commonly recognized as the standard for ambulatory esophageal 24-hour pH monitoring and is used for catheter-based pH or pH-impedance monitoring.

All medical procedures carry some risks. The risks of catheter insertion into the nasal passage include: discomfort, nasal pain, minor bleeding, runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation. In rare instances, the catheter may be misdirected into the trachea causing coughing or choking, or the catheter may shift up or down causing false results. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. The system is not compatible for use in an MRI magnetic field.

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 to 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 materialsto 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) adverse events related to our products or 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 Current Treatment Options in Gastroenterology 2007; 10: 391-400
2 Am J Gastroenterol 2003;98

Contact Information