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Given Imaging Ltd. (GIVN) Announces Data at UEG Week Confirms PillCam® SB's Role as the Diagnostic Gold-Standard for Small Bowel Diseases


10/22/2012 9:04:13 AM

AMSTERDAM, THE NETHERLANDS--(Marketwire - October 21, 2012) - Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the presentation of new data underscoring PillCam® SB's role as the gold standard for diagnosing small bowel diseases. Particularly noteworthy were studies on its use in the diagnosis of Iron Deficiency Anaemia (IDA) and celiac disease, as well as how it can optimize healthcare system resources. The studies were presented at the United European Gastroenterology Week, taking place in Amsterdam from October 20-24, 2012. Given Imaging is exhibiting at booth #56 from Oct 22-24.

"PillCam SB capsule endoscopy is well accepted as the most patient-friendly way to visualize and monitor diseases affecting the small bowel mucosa," said Christophe Cellier, MD, Hôpital Européen Georges Pompidou, Dept. de Gastroentérologie, Paris, France. "The data presented this year at UEG Week expands upon our existing knowledge by showing its value in the diagnosis and monitoring of additional conditions including IDA and celiac disease."

Key data showing the long-term value of PillCam SB in GI bleeding, Iron Deficiency Anaemia (IDA) and refractory celiac disease include:

  • What is the Importance of Capsule Endoscopy in Obscure Gastrointestinal Bleeding and Its Value in Predicting Bleeding in the Long-Term? (P1453). Asli Ormeci, MD, Istanbul University Istanbul Medical Faculty-Gastroenterohepatology, Istanbul, Turkey, and colleagues presented data from a 36-month study showing that the sensitivity and specificity of capsule endoscopy in predicting re-bleeding was 100% and 93% respectively. The authors concluded that the data show PillCam SB's long-term value in OGIB.

  • Diagnostic Yield of Small Bowel Capsule Endoscopy in Iron Deficiency Anaemia Compared to Obscure Bleeding (P1550). Based on a retrospective analysis of more than 800 patients who had prior inconclusive upper and lower GI endoscopy, Myriam Knieper, MD, Hanseklinikum Gastroenterology, Stralsund, Germany, and colleagues found that capsule endoscopy had a relevant diagnostic yield when used for IDA. The investigators concluded that small bowel capsule endoscopy could be helpful in diagnosing unexplained IDA.

  • Diagnostic Yield of Capsule Endoscopy in Refractory Celiac Disease (P0530). Maximilien Barret, MD, Christophe Cellier, MD, Hôpital Européen Georges Pompidou, Dept. de Gastroentérologie, Paris, France, and colleagues found concordance of capsule endoscopy with histology which could help to predict refractory celiac disease (CD). They concluded that capsule endoscopy may play a key role in the diagnostic work-up of patients with symptomatic CD and follow-up of non-responsive CD.

Additional data showing PillCam SB's economic value in an outpatient setting, as well as the benefit that standardized training has on increasing diagnostic skills include:

  • Diagnostic Yield and Safety of Small Bowel Capsule Endoscopy in Clinical Practice: Prospective Data from a Regional Registry (P206). Marco Soncini, MD, Sofar Ao San Carlo Borromeo, Milan, Italy, and colleagues presented data from a regional registry from 32 centers. The study found that, through shifting from an inpatient to an outpatient procedure, which provided comparable clinical results in both settings, the use of small bowel capsule endoscopy helped shorten the waiting list and thus ensured a substantial sparing of resources.

  • Small Bowel Capsule Endoscopy: Improvement of Diagnostic Skills After Basic Hands-On Training Courses (P769). Since capsule endoscopy is the gold-standard in the evaluation of the small bowel, Olaf Humbla, MD, Bethesda Krankenhaus Bergedorf Klinik für Innere Medizin, Hamburg, Germany, and colleagues evaluated the need and impact of formal basic courses, and found that training with hands-on demonstrations significantly improves diagnostic skills related to correct diagnosis, thus further enhancing the relevance of small bowel capsule endoscopy.

About United European Gastroenterology
UEG, or United European Gastroenterology, is a professional non-profit organization combining all the leading European societies concerned with digestive disease. Together, their member societies represent over 22,000 specialists, working across medicine, surgery, pediatrics, GI oncology and endoscopy. This makes UEG the most comprehensive organisation of its kind in the world, and a unique platform for collaboration and the exchange of knowledge.

UEG's mission is continually to improve standards of care in gastroenterology, and promote ever greater understanding of digestive and liver disease -- among the public and medical experts alike. As part of that work, it runs a number of education and training courses facilitated by highly respected experts. UEG also organizes UEG Week -- the largest and most prestigious meeting of its kind in Europe. UEG Week has been running since 1992, in a variety of major cities, and now attracts more than 14,000 people from across the world. For more information, please visit www.ueg.eu.

About PillCam® SB
The PillCam® SB video capsule is a minimally invasive procedure to visualize and monitor lesions associated with inflammatory bowel disease (IBD), Crohn's disease and obscure GI bleeding (OGIB). The PillCam 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, or skin irritation. The risks of the PillCam patency capsule include capsule retention and aspiration. 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 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.

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, 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.


For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-212-867-1762
flazar@lazarpartners.com
dcarey@lazarpartners.com

Israel Investor Contact:
Nava Ladin
Gelbart Kahana Investor Relations
+972-3-6074717
nava@gk-biz.com



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