LONDON--(Marketwire - 11/24/09) - Given Imaging Ltd. (NASDAQ:GIVN - News), the global leader in patient-friendly GI diagnostic and monitoring solutions, today announced three new studies that demonstrate the clinical utility of PillCam SB capsule endoscopy in providing physicians with critical information on how they manage and/or diagnose intestinal disorders. These novel studies were carried out in pediatric patients with gastrointestinal symptoms, including children with known or suspected Crohn’s disease. The three studies were presented at the Gastro 2009 conference taking place in London from November 21 to 25. Given Imaging is exhibiting at booth #83 at the conference.
In presentation # OP182, Professor Annette Fritscher-Ravens, Department of Interdisciplinary Endoscopy, University Hospital Kiel, Germany, concluded that physicians should consider wireless capsule endoscopy exams for children under eight years of age when other diagnostic methods failed to identify the cause of their GI symptoms. Physicians participating in this study changed the clinical management 100 percent of the time when capsule endoscopy studies revealed pathology. The study also concluded that negative findings may be as useful as positive findings in influencing the patient management plan.
“Capsule endoscopy is a powerful, non-invasive imaging modality that can impact pediatric patient outcomes,” said Dr. Fritscher-Ravens. “If no cause for symptoms can be determined, capsule endoscopy should always be considered, as both positive and negative findings from CE exams have led us to change how we manage pediatric patients, which often improves their quality of life.”
The second, a poster presentation (P1369) led by Dr. Ernest G. Seidman, Professor of Medicine and Chair of IBD at McGill University Health Center, Montreal, Canada, concluded that capsule endoscopy is clinically useful in symptomatic pediatric patients with known Crohn’s disease when endoscopic and barium studies are negative. As a result of the CE findings, study investigators changed how they clinically managed more than half of the patients in the study.
“For those children with Crohn’s disease who still experience symptoms, we have learned capsule endoscopy findings can alter the way we manage their disease,” said Dr. Seidman. He went on to state, “This included important management decisions, such as using anti-TNF monoclonal antibody therapy rather than proceeding with surgery.”
A third poster presentation (P0195) led by Salvatore Cucchiara, MD, PhD, Pediatric Gastroenterology Unit, Sapienza University of Rome, concluded that information from PillCam SB procedures can help classify IBD as either Crohn’s disease, ulcerative colitis or unclassified IBD among children. These results were determined to have important clinical and therapeutic implications.
“Children remain an important patient group for whom accurate diagnosis and treatment can significantly impact their lives, and we are pleased that these studies validate PillCam SB’s broader role in their diagnosis and management,” said Homi Shamir, President and Chief Executive Officer, Given Imaging.
About Crohn’s Disease
Crohn’s disease is a chronic condition that causes inflammation in the lining of the small intestine wall. It usually occurs in the lower part of the small intestine called the ileum, but 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 theory most widely held is that the immune system is over-reacting to a virus or bacterium that causes inflammation.(3) An upper GI endoscopy, upper GI radiography series and colonoscopy are often used to test for inflammation and intestinal abnormalities. Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease.(5)
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 1,100 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.
The PillCam SB 2 video capsule, when used with the PillCam Platform, is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age and up. The PillCam SB 2 capsule and the PillCam Platform are not cleared for children younger than two years old and should not be used outside of the context of approved clinical trials with such patients.
Study # OP182 was partly supported by Given Imaging.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam? Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam SB, the esophagus through PillCam ESO and the colon with PillCam COLON [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(TM) 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). Given Imaging’s products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to better diagnose diseases of the esophagus, small bowel and colon [PillCam COLON is not cleared for use in the USA.] and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. 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 Singapore. For more information, please visit http://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, and (16) 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, 2008. 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://qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease Frequently Asked Questions
(2) Crohn’s and Colitis Foundation of America (www.ccfa.org)
(3) National Institute of Diabetes and Digestive and Kidney Diseases (www.niddk.nih.gov) Contact:
For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-866-GIVEN-IR
