Healthcare Industry News: Capsule Endoscopy
News Release - October 25, 2012
Given Imaging Announces Podium Presentation at ACG Shows Economic Value of SmartPill(R)Study Concludes SmartPill Is a More Cost-Effective Test for Patients With Upper and Lower Functional GI Symptoms Than Current Standard of Care
LAS VEGAS, NV--(Healthcare Sales & Marketing Network) - Given Imaging Ltd. ( NASDAQ : GIVN ), a world leader in GI medical devices and pioneer of Capsule Endoscopy, today announced new data that was presented at the American College of Gastroenterology 2012 annual meeting that highlighted the economic value of using its newly acquired SmartPill GI monitoring system in evaluating patients with both upper and lower functional gastrointestinal symptoms.
Traditionally, patients with symptoms of upper or lower gastromotility disorders undergo gastric emptying scintigraphy and colonic sitzmarker testing. Due to the expense of conducting these types of evaluations, SmartPill is being studied as a cost-effective, radiation-free alternative for measuring gastric emptying and total GI transit times along with pH, pressure and temperature of the GI tract.
In the podium presentation, Cost-Effectiveness Analysis of Wireless Capsule Motility (WCM) Compared to Traditional Testing for Patients with Functional Gastrointestinal Disorders (#62), Lauren Gerson, MD, MSc, FACG, Stanford University, presented findings from a five year Markov analysis comparing the SmartPill GI monitoring system with traditional testing, including gastric emptying scintigraphy and colonic sitzmarker testing, of upper or lower GI motility disorders. Using costs based on 2011 Medicare rates, the study used a 45-year-old female patient with both upper and lower GI functional symptoms as the base case to analyze cost and quality-adjusted life years. The study found that the incremental cost-effectiveness ratio for wireless capsule motility testing was $18.437 and concluded that SmartPill was the more cost-effective approach in patients with both upper and lower GI symptoms compared with traditional testing. The study also concluded that for patients with isolated upper GI or lower GI symptoms, traditional testing is preferred.
"The economic indicators presented in this study, along with the proven benefits of SmartPill as a patient-friendly tool for evaluating motility disorders like gastroparesis and constipation, make SmartPill an exciting addition to our portfolio of innovative GI solutions," said Homi Shamir, President and CEO, Given Imaging. "We look forward to leveraging Given Imaging's substantial technological, clinical, marketing and sales resources to help realize SmartPill's full potential."
The American College of Gastroenterology is a recognized leader in educating GI professionals and the general public about digestive disorders. Their mission is to serve the evolving needs of physicians in the delivery of high quality scientific, humanistic and cost-effective health care to gastroenterology patients. For more information, visit http://gi.org.
About SmartPill® GI Monitoring System
SmartPill is an ingestible medical capsule device that provides data that can assist physicians in the evaluation of gastroparesis and chronic constipation. The SmartPill GI Monitoring System was granted initial 510(k) release from the U.S. Food and Drug Administration (FDA) in July 2006.
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 impedance, 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.
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, 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 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.
Source: Given Imaging
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