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Given Imaging Ltd. (GIVN) Reports New Studies Confirming Clinical Utility of Its Functional Gastrointestinal Diagnostics Products


10/22/2012 9:02:54 AM

AMSTERDAM, THE NETHERLANDS--(Marketwire - October 21, 2012) - Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced new studies confirming the clinical utility of its functional GI products including ManoScan™ and the Bravo® pH monitoring system. The data were presented at the United European Gastroenterology Week taking place in Amsterdam from October 20-24. Among the abstracts presented were those discussing an optimal technique for high resolution manometry (HRM), as well as data on Bravo® pH monitoring system showing that prolonged pH measurement helps predict treatment outcomes with confidence. Given Imaging is exhibiting at booth #56 from Oct 22-24.

"These new studies indicate that the medical community continues to find additional insights to be gained through high resolution manometry and pH monitoring that will help us improve patient care," said Sabine Roman, MD, PhD., Lyon. "Different disease states, including achalasia and diabetes, cause different problems with motility. HRM allows physicians to diagnose the cause underlying the problem, which informs treatment. In addition, a new study on Bravo pH monitoring demonstrates the value of prolonged pH measurement in predicting outcomes with confidence.

Among the studies presented about HRM at UEG Week:

  • Esophageal High Resolution Manometry (HRM) in Achalasia: Evaluation of the Classification in a French Multicentric Cohort (P1562) by Sabine Roman, MD, PhD., of the Hospices Civils de Lyon, Edouard Herriot Hospital, Digestive Physiology, (Chief of department : Pr Mion), Lyon, France, and colleagues. In this study, the researchers used HRM and the Chicago Classification to evaluate and classify patients diagnosed with achalasia. They successfully classified the patients by subtype, which assisted them in drawing conclusions about the pathophysiology of the various types of achalasia.

  • What Diagnosis Obtained in High Resolution Manometry Depending on the Body Position Correlates Better with Gastroesophageal Reflux Assessed by pH-Metry? (P1556) by Constanza Ciriza de Los Rios, MD, of the Hospital 12 de Octubre-Gastroenterology in Madrid, Spain, and colleagues. This study focused on optimal body position for esophageal motility assessment by HRM, and aimed to determine which results obtained in HRM depending on body position predict better gastroesophageal reflux. The study authors performed HRM upright and in supine on 111 patients, all of which had double channel 24 hour-pH metry. The researchers concluded that hypotensive lower esophageal sphincter and hiatus hernia were more frequently diagnosed upright in patients with abnormal pH-metry, and thus the sitting position is better at identifying predisposing pathophysiological mechanisms of gastroesophageal reflux.

In addition, the following study was presented on Bravo® pH monitoring system:

  • Reflux Associated Symptoms Per Day and Symptom Index with Confidence Intervals: New Indices of Reflux-Symptom Association For Diagnosis Of Reflux Disease That Improve Prediction of Treatment Outcome From Prolonged pH-Monitoring (P0446) by Mark Fox, MD MA MRCP, Department of Gastroenterology, Nottingham Digestive Diseases Centre, NIHR Biomedical Research Unit, Nottingham University Hospital, Queen's Medical Centre, Nottingham, United Kingdom, and colleagues. This study aimed to obtain metrics from prolonged wireless pH-studies using Bravo technology to discriminate healthy patients from those with reflux, and then predict proton-pump inhibitor (PPI) response. To accomplish this, the researchers recruited healthy volunteers and patients with reflux symptoms and assessed their symptoms with and without PPI medication. They were able to differentiate healthy volunteers from patients using Bravo pH monitoring to evaluate reflux symptoms, and concluded that prolonged pH-measurement is required to predict treatment outcomes with confidence.

About United European Gastroenterology
UEG, or United European Gastroenterology, is a professional non-profit organization combining all the leading European societies concerned with digestive disease. Together, their member societies represent over 22,000 specialists, working across medicine, surgery, pediatrics, GI oncology and endoscopy. This makes UEG the most comprehensive organisation of its kind in the world, and a unique platform for collaboration and the exchange of knowledge.

UEG's mission is continually to improve standards of care in gastroenterology, and promote ever greater understanding of digestive and liver disease -- among the public and medical experts alike. As part of that work, it runs a number of education and training courses facilitated by highly respected experts. UEG also organizes UEG Week -- the largest and most prestigious meeting of its kind in Europe. UEG Week has been running since 1992, in a variety of major cities, and now attracts more than 14,000 people from across the world. For more information, please visit www.ueg.eu.

About Digestive Motility
Motility disorders occur when the natural muscle movements of the digestive tract that help to propel food content are impaired. These disorders can impact a portion or all of the digestive tract. Examples of digestive motility diseases and disorders include chronic intestinal pseudo-obstruction (CIP), gastroparesis, dysphagia, and diffuse esophageal spasm (DES)(1). Achalasia is a motility disorder that occurs when there is a complete lack of muscle movement within the esophagus, preventing food from entering the stomach. Symptoms are difficulty swallowing liquids and solids and can also include regurgitation, vomiting, weight loss, and atypical chest discomfort.(2)

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, and Digitrapper® pH-Z impedance, and the SmartPill® GI 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 www.givenimaging.com.

About ManoScanESO
ManoScan ESO is a test used to assess esophageal motor function by providing complete physiological mapping, from the pharynx to the stomach, with a single placement of a catheter. This advanced diagnostic technology allows physicians to evaluate causes of gastric reflux, difficulty swallowing, functional chest pain and pre-operative evaluations. As the first solid-state commercially available high resolution manometry technology, ManoScan™ remains the global market leader in technologically advanced solutions for assessing gastrointestinal motility. It is the only platform validated for the Chicago Classification System, the industry's standardized categorization scheme for identification of motility disorders. All ManoScan ESO systems incorporate the new ManoView ESO v 3.0.

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.

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 payers, (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) http://www.agmd-gimotility.org/about_motility.htm

(2) http://www.iffgd.org/site/gi-disorders/adults/motility-disorders


For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-212-867-1762
flazar@lazarpartners.com
dcarey@lazarpartners.com

Israel Investor Contact:
Nava Ladin
Gelbart Kahana Investor Relations
+972-3-6074717
nava@gk-biz.com



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