- Cost analysis shows PillCam ESO saves more than $10,000 versus a scoring-based risk stratification strategy for patients at low risk - - PillCam ESO is significantly more effective than nasogastric tubes in detecting upper GI bleeding and comparable to EGD in identifying upper GI ulcerations - SEATTLE, Oct. 21, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results from two studies highlighting the clinical and economic benefits of PillCam ESO in the evaluation of patients with acute upper gastrointestinal (GI) bleeding in the emergency department setting. Both studies were presented during the American College of Emergency Physicians (ACEP) Scientific Assembly, the largest annual international emergency medicine conference, which took place in Seattle, Washington, October 14-17, 2013. "The Cost-Effectiveness Analysis of Video Capsule Endoscopy Compared to Other Strategies to Manage Acute Upper Gastrointestinal Hemorrhage in the Emergency Department " (poster 65), presented by Andrew Meltzer, M.D., George Washington University Medical Center, Washington, DC and colleagues, analyzed the cost variances among diagnostic strategies including PillCam capsule endoscopy, risk stratification using the Glasgow-Blatchford score, nasogastric tube placement and an admit-all strategy. They found that, for patients at low risk of requiring endoscopic hemostatic intervention, capsule endoscopy was the dominant strategy with a cost of $5,691. These metrics were significantly stronger than all of the remaining strategies including the nasogastric tube strategy with added incremental cost of $2,469, the risk stratification strategy with an incremental cost of $10,695 and the admit-all strategy with an incremental cost of $17,076 versus capsule endoscopy. For moderate risk patients, capsule dominated an admit-all strategy with a cost of $9,190 versus an added incremental admit-all cost of $13,098. Based on this analysis, researchers concluded that capsule endoscopy may be cost-effective for low and moderate risk patients presenting with upper GI bleeding to the emergency department. Although the risk stratification strategy utilizing the Glasgow-Blatchford score is recommended, neither this strategy nor the nasogastric tube are utilized by most emergency departments. A 2012 National Institute of Health funded study found that one in every five Americans has at least one visit to the emergency department per year 1 , with a large number of patients depending on the emergency department to obtain acute medical care, resulting in increased healthcare costs. "PillCam's unique ability to directly visualize the upper GI tract non-invasively to identify the presence or absence of a hemorrhage could offer a novel and cost-effective approach in the emergency department setting," said Dr. Meltzer. "The cost savings on a per-patient basis could have a positive impact on the economic outcomes health care systems are striving for today."
"Capsule Endoscopy In Acute Upper Gastrointestinal Hemorrhage: A Prospective Cohort Study" , from Ian Gralnek, M.D., Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel, and colleagues, compared PillCam ESO to nasogastric tube in determining the presence of blood in emergency department patients with suspected upper GI bleeding. PillCam ESO was also compared to esophagogastroduodenoscopy (EGD) in determining the source of bleeding and the presence of inflammatory lesions. After fully conducting all three exams, blood was detected in the upper GI tract in 83.3% of patients by PillCam ESO and in only 33.3% of patients by nasogastric tubes (p=0.035). In identifying inflammatory lesions, PillCam ESO had similar findings compared to EGD. Based on these results, the researchers concluded that PillCam ESO is a feasible and safe exam to facilitate patient triage and earlier endoscopy.About PillCam ESO The PillCam ESO video capsule was cleared by the U.S. Food and Drug Administration in patients 18 years and older to visualize the esophagus. PillCam ESO contains imaging devices and light sources at both ends of the capsule to capture 18 images per second as it passes down the esophagus in a patient-friendly thirty-minute procedure. The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. After ingesting the PillCam capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created by an MRI device. Endoscopic placement may present additional risks. Medical, endoscopic or surgical intervention may be necessary to address these complications, should they occur. Please consult the product user manual or refer to givenimaging.com for detailed information. 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.
1 National Center for Health Statistics (2006) Health: United States, 2006, With Chartbook on Trends in the Health of Americans. Hyattsville, MD: NCHS.
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