SOURCE: Given Imaging

Given Imaging

October 31, 2011 07:00 ET

Given Imaging Announces New Studies Validate Use of PillCam SB® to Detect and Monitor Crohn's Disease

Studies Clarify Best Candidates for PillCam Endoscopy in Confirming Crohn's Disease; Study Highlights Value of Capsule Endoscopy for Monitoring Mucosal Healing

NATIONAL HARBOR, MD--(Marketwire - Oct 31, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced new data that underscore the value of using PillCam SB for detecting and monitoring Crohn's disease. Studies confirmed the high diagnostic yield of PillCam SB for Crohn's disease in patients with specific inflammatory markers and other symptoms. Such concordance may help doctors identify which patients are most appropriate for undergoing PillCam capsule endoscopy to help improve the detection of Crohn's disease.

An additional study established the value of using PillCam endoscopy in combination with the Lewis Score to assess mucosal healing in patients with small bowel Crohn's disease who are undergoing therapy. One study was published in the European Journal of Medicine earlier this month while the other abstract was presented at the American College of Gastroenterology 2011 Annual Scientific Meeting, taking place from October 28th through November 2nd at the Gaylord National Harbor Hotel & Conference Center in National Harbor, Maryland. Given Imaging is exhibiting at booth #1601 throughout the conference.

"Many patients with Crohn's disease undergo multiple tests over an extended period of time before they are given a definitive diagnosis. This results in delayed treatment, additional expense and unnecessary suffering. Now we know that the presence of specific inflammatory blood markers coupled with other symptoms indicate which patients may be appropriate to undergo PillCam capsule endoscopy. This will result in the earlier diagnosis of Crohn's disease. Treatment will begin earlier, as a result," said Doug Wolf, M.D., Atlanta Gastroenterology Associates. "The use of PillCam will have a beneficial impact on the care of Crohn's disease patients."

Use of PillCam SB to Detect Crohn's Disease

Earlier this month, a new open-label prospective study to evaluate the efficacy and clinical outcomes of capsule endoscopy in patients with chronic abdominal pain was published in the European Journal of Medicine. Seventy-two patients with abdominal pain for longer than three months and for whom previous diagnostic tests were inconclusive were enrolled in the study. The overall diagnostic yield for capsule endoscopy was 44.4%. The capsule endoscopy findings increased significantly in patients with similar symptoms and abnormal inflammatory markers -- ESR (erythrocyte sedimentation rate) and CRP (c-reactive protein) to 66.7% and 90.1%, respectively. The researchers concluded that the diagnostic yield of capsule endoscopy in patients with chronic abdominal pain and abnormal inflammatory markers is high and the results can have an impact on clinical practice. In addition, the findings from capsule endoscopy in conjunction with inflammatory markers are useful to assess the activity and predict the relapse of disease, thus impacting clinical management.

These findings were further supported by a poster presentation, abstract P1120, entitled, "Are Inflammatory Markers Abnormal in Patients with Suspected Crohn's Disease Undergoing Video Capsule Endoscopy?" presented during the Annual Scientific Meeting. Researchers from the University of Pennsylvania, Philadelphia, PA, and Montefiore Medical Center, New York, NY, evaluated whether the inflammatory markers (ESR and CRP) were abnormal in 56 patients undergoing capsule endoscopy screening for suspected Crohn's disease. The study authors concluded inflammatory markers can be abnormal in patients undergoing capsule endoscopy and that the majority of patients who were not found to have Crohn's disease using capsule endoscopy did not have inflammatory markers present.

Additional data from a multi-center study, abstract P707*, entitled, "Predictive Factors That May Differentiate 'Suspected' Crohn's Disease from 'Definitive' Crohn's Disease - A Prospective Cohort Study," highlighted the need for specific factors to help definitively diagnose small bowel Crohn's disease. The study enrolled 80 patients with suspected Crohn's disease, defined as a change in bowel habits, abdominal pain, and/or elevated inflammatory markers, as well as additional symptoms of weight loss, anemia, etc. All patients underwent a capsule endoscopy and ileocolonoscopy procedure to evaluate the presence of Crohn's disease. Overall, 20 patients were definitively diagnosed with Crohn's disease. The study authors concluded that in their patient population, those diagnosed with Crohn's disease by capsule endoscopy and/or ileocolonoscopy, weight loss combined with abdominal pain and anemia appear to be predictive of a definitive diagnosis of Crohn's disease.

Use of PillCam SB in Monitoring Mucosal Healing

Poster presentation, abstract P721**, entitled, "Open Label Investigation of Mucosal Healing in Patients with Small Bowel Crohn's Disease Treated with Certolizumab Pegol Assessed by Wireless Capsule Endoscopy," highlighted the utilization of PillCam capsule endoscopy for monitoring the efficacy of certolizumab pegol (CZP) in patients with moderate-to-severe Crohn's disease. The study included five patients who on average had Crohn's disease for 16.6 years. CZP was administered every two weeks for the first month and then once per month for the following five; capsule endoscopy using the Lewis score was performed at baseline showing a mean score of 1,976 and again at weeks 16 and 26. At the conclusion of the study, the Lewis score fell to a mean of 639 and four of the five patients had significant mucosal healing as demonstrated by PillCam capsule endoscopy. The study authors concluded that capsule endoscopy along with the Lewis Score is a valuable diagnostic test to assess mucosal healing in patients with small bowel Crohn's disease treated with CZP.

An additional study, abstract P344, entitled, "Prospective Evaluation of the Usefulness of Patency Capsule in Crohn's Disease," reaffirmed the value of the PillCam® patency capsule to appropriately select patients for PillCam SB capsule endoscopy. Researchers from Hospital São in Porto, Portugal analyzed the results of 150 PillCam patency capsule procedures in patients with known or suspected Crohn's disease, and concluded that the patency capsule is effective in identifying which patients can undergo PillCam capsule endoscopy without risk of retention.

*This research was supported by an industry grant from Given Imaging. Dr. Jonathan Leighton, Dr. Stanley Cohen, Dr. Ervin Toth, Dr. David Cave, Dr. Ernest G. Seidman, Dr. Rami Eliakim, and Dr. Ian Gralnek are paid consultants for Given Imaging Ltd.
**This research was supported by an industry grant from UCB

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.(4)

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 1,500 peer-reviewed studies. It is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB is the gold standard in small bowel evaluation.

The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the Agile™ GI patency test include capsule retention and aspiration. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

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 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 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, (18) 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) qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease Frequently Asked Questions.
(2) Crohn's and Colitis Foundation of America (ccfa.org)
(3) National Institute of Diabetes and Digestive and Kidney Diseases (niddk.nih.gov)
(4) http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html

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