SOURCE: Given Imaging

May 20, 2008 12:06 ET

Three Clinical Studies Confirm PillCam® ESO's Promise as a Screening Tool for Esophageal Varices in Cirrhotic Patients

SAN DIEGO, CA--(Marketwire - May 20, 2008) - Given Imaging Ltd. (NASDAQ: GIVN) today announced that data from three new studies underscore the value of PillCam® ESO capsule endoscopy as a valuable, patient-friendly tool for screening cirrhotic patients for esophageal varices. One study will publish in the June 2008 issue of Hepatology and two other abstracts were presented during the annual Digestive Disease Week® (DDW) 2008 conference taking place in San Diego from May 17-22.

The current "gold standard" screening method, esophagogastroduodenoscopy (also known as EGD or upper endoscopy), is uncomfortable, invasive, costly and requires sedation, which may limit adherence to screening programs, according to the study in Hepatology. Fifty percent of cirrhosis patients develop varices within 10 years(1). Twenty percent of patients who develop large varices die within six weeks(2).

Led by Roberto de Franchis, M.D., Head, Gastroenterology and GI endoscopy Unit, Ospedale Policlinico, Mangiagalli and Regina Elena Foundation, Milano at the Department of Medical Sciences, University of Milan, the Hepatology study assessed the diagnostic performance of PillCam ESO using EGD as the gold standard. While agreement between the two methods was 86%, the study did not meet its primary endpoint of demonstrating equivalence to EGD within 10%. There was significant agreement (91%) between the two methods with respect to specificity in determining those patients who had large varices and those with small varices, although sensitivity was lower at 78%. Overall, patients significantly preferred PillCam ESO to EGD. The results of the study also confirmed the utility of a standard scoring system to grade images of varices captured with PillCam ESO, and the authors did note that in some instances, grading by the capsule was thought to be more precise than EGD.

"Since patients rate capsule endoscopy as more comfortable and convenient, broader use of this tool may lead to better adherence to guidelines and ultimately improve the outcomes if more patients undergo screening," said Dr. de Franchis.

A second study presented as a poster at DDW 2008, "Screening for Esophageal Varices in End-Stage Liver Disease: Utility of Esophageal Capsule Endoscopy," (Abstract #M1370) and led by Ayodele T Osowo, MD, and colleagues found that PillCam Esophageal capsule endoscopy identified varices in 38% (83) of the 217 patients in a prospective study. PillCam also helped physicians diagnose gastric varices in 1.3% (3) of the patients and portal hypertensive gastropathy in 11% (24).

"Our study shows that capsule endoscopy is a valuable screening tool for esophageal varices in cirrhotic patients," said Dr. Osowo, fellow at the Mayo Clinic in Scottsdale, Arizona. "Other findings in this study suggest it may also be useful for diagnosis of other co-existent esophageal and gastric pathologies. Relative ease of ingestion and convenience may make this a more attractive alternative for patients." Dr. Osowo presented the poster on Monday, May 19 at DDW.

A third study presented at the DDW podium, "Randomized Controlled Trial of Esophageal Capsule Endoscopy Versus Standard Endoscopy for Screening in Patients Pre-Liver Transplantation. Assessment of Inter-Observer Variability and Patient Preferences," (Abstract #472), presented by lead author Lauren B. Gerson MD, MSc from Stanford Unversity School of Medicine, compared PillCam ESO's diagnostic results to EGD in 24 patients awaiting liver transplants. An expert hepatologist performed the EGDs. Two blinded independent faculty experts interpreted ECE images.

EGD detected varices in 12 (50%) of the patients and PillCam ESO found varices in 11 (46%) of them. Varices were graded as F1=small straight varices; F2=enlarged tortuous varices < 1/3 of the lumen; and F3=large coil-shaped varices greater than or equal to 1/3 lumen. Both methods detected significant (grade F2-F3) varices in 8 patients. The EGD and PillCam ESO readers demonstrated 100% agreement for small varices (Grades F0/F1) and agreed 88% of the time for the higher grade (F2/F3) varices. A majority of the patients (61%) preferred PillCam endoscopy over EGD (9%), and patients reported less discomfort (p=0.03), greater satisfaction (p=0.03) and less fatigue (p < 0.001) associated with the ECE examination compared to standard EGD.

"In patients awaiting a liver transplantation who are undergoing screening for the presence of esophageal varices, PillCam capsule endoscopy was sensitive, specific, and preferred by patients compared to standard sedated endoscopy," said Dr. Gerson, Associate Professor of Medicine at Stanford University. "There was also good agreement between capsule endoscopy experts regarding the grading of varices. If the goal of endoscopic screening is to identify patients with large varices who can undergo subsequent endoscopic or medical therapy, our study demonstrated that all of the patients at high risk of bleeding from esophageal varices would have been identified accurately by esophageal capsule endoscopy. By using PillCam ESO to screen for varices, the majority of patients with advanced liver disease can be spared the discomfort and time associated with standard upper endoscopy, and potentially the risk of exacerbation of underlying encephalopathy associated with the usage of conscious sedation."

"We are encouraged by the growing body of data supporting PillCam ESO," said Homi Shamir, president and CEO, Given Imaging. "Since our inception, Given Imaging has sought to redefine gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. Studies such as these confirm the value of PillCam products."

About Esophageal Varices

Chronic liver disease affects 360 out of every 100,000 people in the U.S., results in 300,000 hospitalizations annually and costs over $2 billion a year according to National Institutes of Health. The two most common diseases leading to varices are cirrhosis and fibrosis of the liver. In cirrhosis of the liver, scar tissue replaces normal, healthy tissue, blocking the flow of blood through the organ and preventing it from working as it should. Portal hypertension and esophageal varices (enlarged veins) are two of the main complications of the disease.

In advanced cases of liver cirrhosis, scar tissue spreads and restricts the blood from flowing through the liver. This can cause the veins in the esophagus to enlarge. It's vital to monitor for the appearance of these enlarged veins, or varices, and to keep track of their size. Roughly one-fourth of these varices eventually start to bleed and 10% to 20% of patients die within six weeks of the bleeding episode.

About PillCam ESO

Cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way, physicians can use PillCam ESO to aid in the detection of disorders such as Barrett's esophagus, a potential precursor for esophageal cancer and esophageal varices, which if left untreated, can result in fatal bleeding. PillCam ESO contains imaging devices and light sources at both ends of the capsule that capture up to 14 images per second, a total of 2,600 color images, as it passes down the esophagus in a twenty minute procedure.

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 17-22, 2008, at the San Diego Convention Center, San Diego, CA. 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 Given Imaging Ltd.

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has a number of available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 700,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). For more information, visit http://www.givenimaging.com.

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) satisfactory results of clinical trials with PillCam COLON (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) 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, 2007. 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) D'Amico G, Pasta L, Madonia S, et al. The incidence of esophageal
varices in cirrhosis. Gastroenterology 2001;120:A2.
(2) D'Amico G, de Franchis R, and the Cooperative Study Group. Upper
digestive bleeding in cirrhosis: post-therapeutic outcomes and prognostic
indicators. Hepatology 2003;38:599-612

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