SOURCE: Given Imaging

Given Imaging

May 22, 2012 11:00 ET

New Studies Confirm Value of Given Imaging's PillCam® SB in Managing Pediatric Patients With Inflammatory Bowel Disease

Data Show that Capsule Endoscopy Helps Improve Care for Pediatric and Adult Patients With Known and Suspected Crohn's Disease

SAN DIEGO, CA--(Marketwire - May 22, 2012) - Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that new studies confirm the value of its PillCam® SB as a tool to help monitor, diagnose and manage pediatric patients with inflammatory bowel diseases (IBD) including Crohn's disease. The results of the studies were presented at Digestive Disease Week® (DDW), being held from May 19-22, 2012, in San Diego.

"PillCam SB has long been the standard imaging tool used to help physicians detect diseases in the small bowel," said Stanley Cohen, MD, of the Children's Center for Digestive Healthcare in Atlanta, Georgia. "New studies continue to show the value of using PillCam SB to help manage pediatric patients with IBD. Evidence shows that PillCam SB is a useful tool to help physicians rule out IBD in children, and also help accurately detect Crohn's disease."

Three key poster presentations were presented on how capsule endoscopy plays an important role in helping to diagnose and monitor both pediatric and adult patients with IBD:

  • Steven B. Min, MD, Division of Pediatrics, Walter Reed National Military Medical Center, Bethesda, MD, and colleagues, presented results of a retrospective chart review (abstract Sa1995) of 66 children with IBD and 17 with suspected IBD. They found that following capsule endoscopy with PillCam SB, physicians changed treatment for 60% of the patients and were able to rule out IBD in 94% of patients with suspected IBD. PillCam SB also revealed more extensive small bowel involvement than concurrent small bowel imaging modalities in 27% of patients.
  • Stanley A. Cohen, MD, Children's Center for Digestive Health Care, Atlanta, GA, and colleagues presented abstract Sa1992, a blinded pilot study that showed that PillCam SB is a useful tool to help monitor for mucosal changes in children with Crohn's disease. The study found that the pediatric Crohn's disease patients enrolled in the study who followed a specific carbohydrate diet saw mucosal and clinical improvement, and that video capsule was an important tool to monitor the mucosal changes, even over a short interval.
  • A third study showed for the first time that the Lewis Score, a scoring index commonly used to assess PillCam SB images of inflamed small bowel tissue, strongly correlates to biomarkers associated with three different subsets of patients with Crohn's disease. Susana Rodrigues, MD, Department of Gastroenterology, Hospital S. Joao, Porto, Portugal, and colleagues presented results of the transversal and multicentric study (abstract Tu1258), that underlines the importance of capsule endoscopy in managing Crohn's disease.

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% 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 esophagus1. Roughly 500,000 Americans suffer from Crohn's disease, and about 20% have a direct relative with some form of inflammatory bowel disease (IBD)2. Crohn's disease 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 inflammation3. Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease4.

Twenty percent of all cases of Crohn's disease affect children, appearing in children as young as seven years old. Crohn's disease appears to run in families, with 20 percent of people with Crohn's having a relative with a form of IBD. In those who have a family history, Crohn's disease appears in the teens and twenties.

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 PillCam patency capsule 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, industry-leading ManoScan high-resolution manometry and Bravo® pH and Digitrapper® pH and impedance monitoring. 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, Brazil and Hong Kong. For more information, please visit www.givenimaging.com.

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 19 - 22, 2012, at the San Diego Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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) 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.ccfa.org/info/about/crohns 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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