SOURCE: Given Imaging

Given Imaging

October 25, 2010 09:10 ET

New Data Show PillCam® SB to Be an Accurate Tool to Evaluate Patients With Crohn's Disease, Functional GI Disorders and OGIB

Data Presented at UEGW Suggest PillCam SB Shows Promise in Monitoring Mucosal Healing in Patients With Crohn's Disease

BARCELONA, SPAIN--(Marketwire - October 25, 2010) -  Given Imaging Ltd. (NASDAQ: GIVN) today announced several new studies that demonstrate PillCam® SB's clinical value in detecting and monitoring Crohn's disease and its utility in managing patients with obscure GI bleeding (OGIB). The studies were presented at the United European Gastroenterology Week (UEGW) 2010 conference taking place in Barcelona, Spain from October 23 to 27, 2010. Given Imaging is exhibiting at booth #36 at the conference. Additional studies were presented demonstrating the value of PillCam® ESO capsule endoscopy and PillCam® COLON capsule endoscopy.

A 93-patient, prospective, blinded study (OP119) compared the diagnostic sensitivity and specificity of capsule endoscopy, MRI, and CT-enterography in patients with suspected or newly diagnosed Crohn's disease. The study was led by Michael Dam Jensen, MD, Vejle Hospital part of Lillebaelt Hospital, Vejle, Denmark. Concluding that capsule endoscopy could be the new gold standard for assessing small bowel Crohn's disease, the study's authors found 100 percent sensitivity and 91 percent specificity for capsule endoscopy compared to 81 and 86 percent, respectively, for MRI and 76 and 85 percent, respectively, for CT.

A second study (P0921) utilized capsule endoscopy to evaluate mucosal lesions prior to administration and following maintenance treatment with infliximab (IFX) or adalimumab (ADA) in patients with Crohn's disease. The 42 Crohn's patients included in the study underwent capsule endoscopy prior to administration of either IFX or ADA and also after one year of maintenance treatment to evaluate the efficacy of treatment on mucosal lesions. In the IFX-treated study group (n=19), two patients showed improvement and all other patients remained the same as determined by capsule endoscopy results. In the ADA-treated group (n=23), two patients demonstrated improvement and all other patients remained without significant changes. The study authors concluded capsule endoscopy shows promise in the monitoring of mucosal lesions. The study was lead by Ladislav Kuzela, MD, Hospital and Health Center Ruzinov, Bratislava, Slovakia.

Additionally, Maria Elena Riccioni, MD, Catholic University, A. Gemelli University Hospital, Rome, Italy concluded that patients with OGIB and negative capsule endoscopy findings had very low re-bleeding rates, based upon a medical record review of 650 consecutive patients over a six-year period. Capsule endoscopy results were negative in 161/650 OGIB cases. Patients were followed up at a median interval of 19 months, with re-bleeding observed only in 19.8 percent (32/161) of cases. The sensitivity and specificity were 93.8 and 100 percent, respectively. The authors also concluded that further, invasive investigations can be deferred in the case of negative capsule findings.

Additional studies presented at the meeting included:

A poster presentation (P0830) "FICE-Enhanced Video Capsule Endoscopy in Patients with Suspected Small Bowel Bleeding: A Randomized Prospective Pilot Study," by Insa Aschmoneit, MD, HSK Wiesbaden (Teaching Hospital of the University of Mainz), Wiesbaden, Germany. The authors concluded that it may be advisable to incorporate FICE-enhanced capsule endoscopy as a red-flag technique for detection of bleeding sources within the small bowel in patients with suspected small bowel bleeding. The results of the 20 patients who had undergone capsule endoscopy with suspected mid-GI bleeding were randomly allocated to two blinded readers for evaluation with either standard imaging or FICE mode reading to determine if FICE improved detection and classification of bleeding. The sensitivity of FICE mode was significantly higher than that of standard imaging (95 v. 66 percent) in the detection of small bowel lesions.

Oral presentation #84, led by Carolina Malagelada, MD, University Hospital Vall d'Hebron, Barcelona, Spain, concluded that abnormal intestinal motility can be demonstrated using computer vision analysis of capsule endoscopy images in a significant proportion of patients with functional intestinal disorders. The authors' original method for non-invasive evaluation of small bowel motility employed computer vision and machine learning techniques to evaluate the capsule endoscopy results of patients with symptoms suggestive of severe dysmotility. Capsule images for 50 healthy subjects were used to establish a normality range and train the computer, after which findings from 20 healthy patients and 80 patients with functional intestinal disorders were tested.

In poster presentation P0832, Ian Gralnek, MD, Rambam Health Care Campus, Haifa, Israel, concluded that esophageal capsule endoscopy better identified acute upper GI hemorrhage compared to NG aspirate, facilitating earlier endoscopic intervention. Compared to EGD, esophageal capsule endoscopy was able to differentiate variceal from non-variceal bleeding and identify peptic disease. The multi-center, prospective pilot and feasibility study analyzed 33 patients referred for specific types of upper GI bleeding. Capsule endoscopy detected blood in the upper GI tract significantly more often than NG (42 percent of the time v. 18 percent) and agreed 100 percent with EGD in identifying variceal v. non-variceal bleeding sources.

In poster #1354, Nikos Viazis, MD, Evangelismos General Hospital, Athens, Greece, concluded that patients undergoing colorectal cancer screening prefer colon capsule endoscopy to colonoscopy based upon less discomfort during the test, less abdominal pain and less loss of a sense of dignity. In the study, 85 asymptomatic patients at average risk underwent both colon capsule endoscopy and colonoscopy after receiving standard bowel prep. After completing both tests, patients were asked to complete a questionnaire that assessed preparation discomfort, examination discomfort, examination-related abdominal pain, loss of sense of dignity and examination preference. Capsule endoscopy preference was significantly higher compared to colonoscopy.

About Crohn's Disease
Crohn's disease is a chronic condition that causes inflammation in the lining of the small intestine wall and can affect any part of the digestive tract. Symptoms can include diarrhea, abdominal pain, weight loss and rectal bleeding. Roughly 50 percent of all cases of Crohn's disease are diagnosed in the last part of the small intestine (the terminal ileum) and cecum. This area is also known as the ileocecal region. Other cases of Crohn's may affect one or more of the following: the colon only, the small bowel only (duodenum, jejunum and/or ileum), the stomach or esophagus.(1) Roughly 500,000 Americans suffer from Crohn's disease, and about 20 percent have a direct relative with some form of inflammatory bowel disease (IBD).(2) It affects men and women equally. The cause is unknown, but the most popular theory is that the immune system is reacting to a virus or bacterium that causes inflammation.(3) Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease.(5)

About Obscure GI Bleeding
Occult gastrointestinal bleeding (OGIB) occurs when blood is lost from the digestive tract without visible, or overt, signs of bleeding.(4) The condition is usually discovered only with positive results for a fecal occult blood test or through detection of iron deficiency anemia, and there are many potential causes. In approximately half of patients with OGIB, the source of bleeding is unexplained.(5)

About Upper GI Bleeding
Upper GI bleeding can result from a variety of causes, including peptic ulcer disease, hemorrhagic gastritis, gastroesophageal varices and Mallory-Weiss syndrome, and is defined as bleeding above the ligament of Treitz, between the duodenum and jejunum. Regardless of the cause of bleeding, a rapid clinical assessment is critical. Acute upper GI bleeding is one of the most common medical emergencies, responsible for approximately 300,000 hospitalizations each year with a mortality rate close to 10 percent.(6)

About PillCam SB
The PillCam SB video capsule measures 11 mm x 26 mm and weighs less than four grams. Now in its second generation, PillCam SB 2 contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures during the course of the procedure. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is clinically validated by more than 1,200 peer-reviewed studies. It is the most accurate, patient-friendly tool for visualization of the small bowel and is used by physicians to evaluate patients with a variety of diseases of the small bowel.

About PillCam ESO
PillCam ESO was cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way. Now in its second generation, PillCam ESO 2 contains imaging devices and light sources at both ends of the capsule that capture up to 18 images per second as it passes down the esophagus in a thirty-minute procedure.

About PillCam COLON
Second-generation PillCam COLON 2 is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 mm. Employing intelligent functionality, PillCam COLON 2 transmits up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study. PillCam COLON 2 received a CE Mark in 2009.

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 uses cutting-edge, wireless technology and advanced software to provide 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). In April, 2010, Given Imaging acquired Sierra Scientific Instruments, the 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 and Hong Kong. For more information, please visit

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) Inflammatory Bowel Disease Frequently Asked Questions.

(2) Crohn's and Colitis Foundation of America (

(3) National Institute of Diabetes and Digestive and Kidney Diseases (



(6) Krumberger, Joanne M. RN, MSN, FAAN. How to manage an acute upper GI bleed. RN/Thomson AHC Home Study Program CE CENTER. March 1, 2005.

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