– Investigators use PillCam SB to determine link between Proton Pump Inhibitor therapy use and Iron Deficiency Anemia – – Additional study reports PillCam SB better than EGD or colonoscopy at identifying bleeding source in patients with diverticular disease – SAN DIEGO, Oct. 15, 2013 (GLOBE NEWSWIRE) -- Given Imaging (Nasdaq:GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced numerous studies underscoring the value of PillCam SB in helping physicians diagnose, identify and treat sources of gastrointestinal bleeding in patients. The studies are being presented at the American College of Gastroenterology's Annual Scientific Meeting and Postgraduate Course (ACG ®), taking place October 11-16, 2013, at the San Diego Convention Center, San Diego, CA, where Given Imaging is exhibiting at Booth #1200 throughout the conference. "Capsule endoscopy has proved beneficial in the detection of a large number of conditions within the gastrointestinal system, including gastrointestinal bleeding," said Neal Patel M.D., Georgia Regents University, Augusta, GA. "Several studies presented at this meeting show that PillCam SB is a useful tool to diagnose and locate the source of gastrointestinal bleeding when other methods have failed, and can guide further therapeutic intervention as an initial diagnostic tool." Key poster presentations being presented at ACG include:
"Is There Still a Need to Perform Video Capsule Endoscopy for GI Bleeding When Colonoscopy Has Already Found Diverticulosis?," poster P1728 : presented by Neal Patel M.D., and colleagues, Georgia Regents University, Augusta, GA, and Jessica McGann, M.D., Medical College of Georgia, Augusta, GA. The investigators sought to determine the diagnostic yield of PillCam SB for the localization of a GI bleed when colonic diverticular disease is present, but not bleeding at the time of an endoscopy. The review of medical records of patients with diverticular disease showed that the diagnostic yield for PillCam SB for patients with diverticular disease and a GI bleed that was not identified on EGD or with colonoscopy was 44%. The yield was even higher in patients 65 years or older (50%) than patients younger than 65 (33%). The study suggests that PillCam SB should be used to identify the source of a GI bleed not identified during EGD or colonoscopy in patients with diverticular disease.
"Diagnostic Yield of Capsule Enteroscopy (CE) for GI Bleeding: Is Balloon Enteroscopy (DBE) Yield Maximized by a Top-down or Bottoms-up Approach?," poster P1368: presented by Wiley Truss M.D., and colleagues, University of Alabama, Birmingham, AL. The investigators examined the most common locations for small bowel mucosal abnormalities detected by Capsule Endoscopy (CE) in order to better direct the route of deep enteroscopic procedures. In the 220 capsule studies that were performed for obscure GI bleeds, 85% revealed some type of mucosal abnormality, but only 58% showed a clinically significant finding, defined as any mucosal abnormality that could explain the patient's clinical presentation. Results showed that the PillCam SB procedure led to further diagnostic and therapeutic intervention in 39% of cases. The diagnostic yield for PillCam SB in obscure GI bleeding is highest in the proximal small bowel and therefore amenable to anterograde deep enteroscopy. PillCam SB offers a valuable initial diagnostic tool for guiding the route of approach for further therapeutic intervention.
"Using Capsule Enteroscopy Imaging to Analyze the Effects of Proton Pump Inhibitor Therapy and Its Association to Iron Deficiency Anemia," poster P524 : presented by Rezwan Ahmed M.D., and colleagues, Marshall University, Barboursville, WV, and John Davitt, M.D., Boston University, Boston, MA. The investigators evaluated PillCam SB as an imaging modality to analyze the link between Proton Pump Inhibitor (PPI) therapy use and Iron Deficiency Anemia (IDA). A retrospective chart review of 200 patients found that the majority of patients had a capsule endoscopy procedure after having a small bowel follow through, upper endoscopy, and colonoscopy. Previous studies have shown that combining camera-based scoping techniques and x-rays with radiopaque contrast serves as a model to detect a large number of pathologies within the gastrointestinal system. The authors concluded that based on present findings and prior negative studies, there is an important association between PPI use and IDA. Healthcare providers should become aware of this link and be judicious with prescribing PPIs to their patients.
An additional study, "Characterizing the Learning Curve and Accuracy of Wireless Capsule Endoscopy Interpretation Amongst Digestive Healthcare Practitioners," poster P1713: presented by researchers at University of Pennsylvania Perelman School of Medicine, PA, Johns Hopkins Hospital, MD, and University of Texas Medical School, TX, evaluated the accuracy and learning curve of wireless capsule endoscopy (WCE) trainees without prior WCE experience including GI fellows, CRNP fellows and senior GI nurses. Results suggest that a minimum of 25 WCE studies, with each study read in its entirety, appear to be sufficient for trainees enrolled in a GI fellowship program where they are actively performing endoscopy. Physician extenders and nurses appear to require interpretation of more than 25 WCE studies before adequate proficiency is achieved.About PillCam® SB The PillCam SB capsule is a minimally invasive procedure to visualize and monitor small bowel abnormalities associated with Crohn's disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its third generation, PillCam SB 3 contains an imaging device and light source and transmits images at a rate between two and six images per second. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB 3 builds on Given Imaging's unique expertise and collaborative efforts as an industry leader that includes more than 2 million uses of PillCam capsules in patients worldwide and more than 1,900 clinical studies.
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 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 monitoring, and SmartPill ® motility 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 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 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.
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