-- Additional Study Highlights Improved Diagnostic Yield for New 12-Hour PillCam SB --
-- Celebrates Two Millionth PillCam Milestone --
ORLANDO, Fla., May 21, 2013 (GLOBE NEWSWIRE) -- Given Imaging (Nasdaq:GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced new studies that confirm the value of PillCam SB in diagnosing, monitoring and managing patients with known or suspected Crohn's disease and other conditions of the small bowel. The studies were presented at Digestive Disease Week® (DDW), taking place May 18-21, 2013, at the Orange County Convention Center, Orlando, FL, where Given Imaging is exhibiting at booth #1059 throughout the conference.
"PillCam SB has long been regarded as an important tool for detecting diseases in the small bowel," said Neel K. Mann, M.D., Associate Director, Small Bowel Enteroscopy, Cedars-Sinai Medical Center. "The exciting new studies being presented at this year's DDW further confirm the utility of small bowel capsule endoscopy in helping physicians monitor mucosal healing in patients with Crohn's disease, and therefore improving outcomes."
Several DDW poster presentations underscore the clinical utility of using PillCam SB in patients with Crohn's disease and PillCam SB's positive impact in improving disease management including:
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Wireless Capsule Endoscopy Improves Outcomes in Nonstricturing Crohn's Disease: An Evaluation of Pre- and Post- Treatment Capsule Endoscopy (CE), poster Sa1634, presented by Neel K. Mann, M.D., M.P.H. and Simon K. Lo, M.D. Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA. This retrospective review showed that capsule endoscopy was able to re-classify disease phenotype in >60% of patients with suspected Crohn's disease or unclassified Inflammatory Bowel Disease, thereby potentially changing the management outcome of these patients. More importantly, capsule endoscopy demonstrated mucosal healing in >70% patients, after assessment of therapy, positively changing disease outcome and achieving therapeutic goal in patients with non-stricturing phenotype.
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Small Bowel Capsule Endoscopy for Assessing Early Postoperative Recurrence of Crohn's Disease: A Prospective Longitudinal Study, poster Su1199, presented by researchers at the Università Tor Vergata, Roma, Italy, analyzed the value of small bowel capsule endoscopy in assessing early postoperative Crohn's Disease recurrence when using ileocolonoscopy (IC) as gold standard. The study concluded that early after surgery for Crohn's disease, small bowel capsule endoscopy can visualize superficial upper GI lesions in select patients that standard techniques do not detect.
- Usefulness of Lewis Score of Capsule Endoscopy in Japanese Patients with Crohn's Disease, poster Tu1350, presented by Sadaharu Nouda, M.D., Ph.D., Department of Internal Medicine, Osaka Medical College, Osaka Japan, and colleagues, analyzed the data from 46 patients with Crohn's disease who underwent capsule endoscopy (CE). The study's aim was to assess the usefulness of the Lewis Score (LS) of CE in standardizing the reporting of small bowel inflammation in Crohn's patients with small bowel lesions. The investigators examined two issues: 1.The correlation between the LS and blood data and that between the LS and Crohn's disease activity index and 2. Analysis of the LS in patients with clinical remission defined as CDA1<150. The study found that CE is useful in patients with Crohn's disease. Further results showed that since clinical remission is not always associated with endoscopic remission, the Lewis Score is also useful in patients with Crohn's disease.
An additional study, 8-Hour CE Versus 12-Hour CE in a Cohort of Hospitalized Patients Undergoing CE for Suspected Small Bowel Disorders, poster Tu1301, presented by Rafiul S. Islam, M.D., Mayo Clinic, Scottsdale, AZ, and colleagues, compared the diagnostic yield and completion rates of 8-hour capsule endoscopy (CE) and 12-hour CE in a cohort of hospitalized patients. The study sought to determine patient characteristics associated with an incomplete CE and define an association with the type of lesions found. Results show that a previous inability to reach the cecum using the 8-hour capsule was accomplished with the 12-hour capsule. Furthermore, the 12-hour capsule produced significantly higher diagnostic yields compared with the 8-hour capsule, even though there was no difference in the completion rates between the two capsules. Incomplete examinations were more common in non-obese patients, and were not influenced by diabetes, narcotic use, motility disorders, or gender.
During DDW, Given Imaging will also be celebrating that more than two million PillCam capsules have been used in patients around the world. This major company milestone underscores capsule endoscopy's profound medical impact.
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.
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 and skin irritation. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
About Digestive Disease Week
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 (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
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® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan® high-resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z, and the SmartPill® GI monitoring systems. 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, Hong Kong and Brazil. 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. Such forward-looking statements include statements relating to the Company exploring strategic alternatives and considering possible strategic transactions involving the Company. 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 ability of the Company to reach agreement on any strategic alternative and/or to complete any such alternative, as well as 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, 2012. 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 to the extent expressly required under applicable law, the Company 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