New Studies Show Patients Benefit From Given Imaging's Diagnostic and Visualization Tools for GERD and Other Esophageal Disorders

Clinical Data Validate 48-Hour Bravo(R) pH Monitoring System for Definitive Diagnosis in Suspected GERD Patients; Award-Winning Study Shows ManoScan(TM) High-Resolution Manometry Helps Patients Get Treatment for Esophageal Disorders

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SAN ANTONIO, TX--(Marketwire - 10/18/10) - Given Imaging Ltd. (NASDAQ:GIVN - News) today announced two new studies underscoring the value of Bravo® pH Monitoring in patients with gastroesophageal reflux disease (GERD). The studies re-affirm the utilization of the Bravo pH Monitoring System's 48 hours of pH data collection in patients with suspected GERD as well as those patients with severe reflux under evaluation for fundoplication. An oral presentation, which was awarded the 2010 ACG/AstraZeneca Fellow Award, showed ManoScan™ high-resolution manometry enabled physicians to improve their ability to definitively diagnose achalasia, the only esophageal motility disorder for which there is a treatment. The studies were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course taking place in San Antonio, Texas, from October 15 through October 20, 2010. Given Imaging is exhibiting at booth #715 at the meeting.Poster presentation, P15, led by Dr. John DiBaise of the Mayo Clinic in Scottsdale, AZ, concluded that collecting 48 hours of pH data compared to only 24 hours can significantly increase the likelihood of a GERD diagnosis. In a study of 964 consecutive patients, researchers analyzed patients' total acid exposure at 24 and 48 hours, observing that 27% of studies categorized as normal after 24 hours were found to be abnormal at the conclusion of 48 hours. Patients were grouped according to whether Bravo placement was performed using sedation or not, and no differences in acid exposure readings were observed based upon placement method."Gastroesophageal reflux disease is a painful disease that has a significant negative impact on the lives of millions of Americans," said Dr. John DiBaise of the Mayo Clinic in Scottsdale, AZ. "These data underscore the value of extended pH monitoring in patients with suspected gastroesophageal reflux disease. It is crucial that we monitor for the full forty-eight hours to confirm or rule out a GERD diagnosis, so we may accurately treat and improve the overall quality of our patients' lives."Other meeting highlights included:

  • Dr. Stanley Benjamin of Georgetown University, Washington, DC, presented poster, P837, analyzing the effectiveness of the Bravo pH Monitoring System compared to traditional 24-hour pH monitoring in patients with refractory GERD, undergoing evaluation for Nissen fundoplication. The retrospective chart review of 24 patients concluded pre-operative 48-hour Bravo pH monitoring testing subsequent to a negative or borderline positive 24-hour pH study is effective for patients with GERD whose symptoms have continued to progress and are undergoing evaluation for fundoplication. The small sample showed a trend in under-representation of severe, refractory GERD in this patient population. The authors recommend further large-scale studies to support these data and the role of Bravo pH monitoring in addition to 24-hour pH testing in patients under consideration for fundoplication.
  • Dr. Robert Lee, of Long Beach VA Health Care System, led oral presentation 12, which concluded that high-resolution manometry (HRM) and high-resolution manometry together with the Chicago Classification (HRM+CC) enabled physicians to improve their detection rate of achalasia. The retrospective review was performed on 101 patients with symptoms of dysphagia who underwent high-resolution manometry at two tertiary care hospitals. Patient files were de-identified and separated into three data files (standard manometry, HRM and HRM+CC), which were then randomized and analyzed by two blinded, independent reviewers who recorded the diagnosis and recommended treatment. Compared to standard manometry, HRM and HRM+CC would have led to changes in clinical management 20% and 27% of the time, respectively.
"GERD affects five to seven percent of people worldwide(1) and continues to be a burdensome illness both from a cost as well as a quality of life point of view," said Homi Shamir, President and CEO, Given Imaging. "We are pleased that our products can help doctors accurately diagnose these patients so they can be treated quickly and appropriately."About Gastroesophageal Reflux Disease
Gastroesophageal reflux (also known as heartburn) occurs when contents from the stomach flow back up into the esophagus. Occasional heartburn 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)
About Achalasia
Achalasia is a rare movement disorder of the esophagus caused when the muscles leading into the stomach are unable to relax very well, often due to nerve damage. Symptoms include: regurgitation of food, chest pain, cough, difficulty swallowing liquids and solids, heartburn and unintentional weight loss. It is treatable by reducing pressure on the muscles leading to the stomach through injections, medication or surgery(2).About the Bravo pH Monitoring System
The Bravo pH Monitoring System is the only catheter-free pH test, using 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, 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 Gastroenterology(3). 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.About ManoScan High-Resolution Manometry
Esophageal manometry is a test to measure the pressure inside the esophagus. During this procedure, a thin, pressure-sensitive tube, or "catheter," is passed through the patient's mouth or nose into the stomach. The test measures the pressure of the muscle contractions along several sections of the tube. Esophageal manometry may be combined with impedance monitoring and is often referred to as upper GI motility testing. Physicians use motility testing in patients with GERD, swallowing disorders, chronic constipation, chronic abdominal pain, intestinal pseudo-obstruction, and unexplained nausea and vomiting(4). The test evaluates how well a patient's digestive tract muscles are functioning. ManoScan high-resolution solid state manometry enables physicians to clearly visualize motility physiology through the length of the esophagus. This technology simplifies these clinical procedures and provides greater diagnostic accuracy than the conventional low resolution technology it replaces.About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal visualization by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam® capsule endoscopy provides physicians with natural images of the small intestine via PillCam® SB, the esophagus through PillCam® ESO and the colon with PillCam® COLON [PillCam COLON is not cleared for use in the USA]. The PillCam® capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). Given Imaging's products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to visualize diseases of the esophagus, small bowel and colon. All Given Imaging products allow patients to maintain normal activities. In April 2010 Given Imaging acquired Sierra Scientific Instruments, a leading provider of specialty GI diagnostic solutions and pioneer of high-resolution manometry for assessing gastrointestinal motility. Sierra Scientific is now a wholly-owned subsidiary of Given Imaging. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Singapore 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 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 and (18) 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, 2009. 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) http://www.iffgd.org/site/news-events/press-releases/2005-1125-gerd-costs
(2) http://www.nlm.nih.gov/medlineplus/ency/article/000267.htm
(3) Am J Gastroenterol 2003;98(4):740-749.
(4) http://www.mountsinai.org/Education/School%20of%20Medicine/Faculty%20Practice%20Associates/Practices/Gastroenterology%20FPA/Patient%20Services/Motility%20Testing
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