AMSTERDAM, THE NETHERLANDS--(Marketwire - October 22, 2012) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced three new studies confirming the value of PillCam® COLON 2 in a range of clinical settings, including as an evaluation tool for triaging FIT-positive patients for subsequent colonoscopy, for patients who are unable to undergo standard colonoscopy, and to assess the extent and severity of ulcerative colitis. The studies are being presented at the United European Gastroenterology Week (UEG Week), taking place in Amsterdam from October 20 - 24, 2012. Given Imaging is exhibiting at booth #56 from Oct 22 - 24, 2012.
"These new studies underscore the value of PillCam COLON 2 and demonstrate a variety of cases in which it is useful," said Juan Manuel Herrerías Gutiérrez, MD, Universidad de Sevilla. "Capsule colonoscopy can serve as a filter for standard colonoscopy, and can also be an alternative to standard colonoscopy both in patients who have ulcerative colitis and in those who cannot or choose not to undergo colonoscopy."
Among the studies presented about PillCam COLON 2 at UEG Week were:
- Preliminary Results of Capsule Colonoscopy as a Filter Test Prior to Standard Optical Colonoscopy in a FIT Positive Screening Cohort (P0929) by Ronan Leen, MD, Tallaght Hospital Dept. of Gastroenterology, Dublin, Ireland, and colleagues. Investigators examined patients who had tested positively with Fecal Immunochemical Testing (FIT) and concluded that since PillCam COLON 2 is safe and well-tolerated with a high NPV (negative predictive value), it could serve as a filter test to determine which FIT positive patients should get standard colonoscopy. Data show that 49% of subjects who undergo standard colonoscopy after positive FIT do not have polyps or colon cancer. The authors conclude that by using PillCam COLON 2 as a filter test to select patients for OC in a screening population, physicians can avoid prescribing unnecessary colonoscopies to those without polyps after positive FIT.
- Second-Generation Colon Capsule Endoscopy for Colorectal Cancer Screening in Patients Unable or Unwilling to Perform Colonoscopy (P0103) by Lucian Negreanu, MD, PhD., Emergency University Hospital Dept. of Internal Medicine 2 Dept. of Gastroenterology, Bucharest, Romania, and colleagues. Researchers aimed to assess the feasibility, accuracy, and safety of PillCam COLON 2 in detecting lesions in patients unable or unwilling to undergo colonoscopy. The researchers included 75 patients with average or increased risk of colorectal neoplasia in their study, all of whom were unable or unwilling to have a standard colonoscopy. They found PillCam COLON 2 to be well-tolerated and to have good sensitivity for the detection of lesions, and concluded that it could be an adequate tool for colorectal examination in patients in which colonoscopy was not appropriate.
- PillCam COLON (C2) vs. Colonoscopy in the assessment of Colon Mucosa in Patients with Ulcerative Colitis (Preliminary Study) (P0104) by Mileidis Esther Sanjuan Acosta, MD, University Hospital Virgen Macare Dept. of Digestive Health, Gastroenterology and Hepatology, Seville, Spain, and colleagues. For the first time, researchers studied the correlation between PillCam COLON 2 and colonoscopy in assessing the extent and degree of disease activity in patients with ulcerative colitis. Using statistical analysis to compare both techniques, the study authors found that the match was "very good" in terms of severity and extent when the procedures achieved a complete study of the colon. Thus, the study authors concluded that PillCam COLON 2 was able to assess the severity and extent of ulcerative colitis at levels comparable to that obtained with colonoscopy.
PillCam COLON 2 is currently not cleared for marketing in the United States.
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® COLON 2
The PillCam® COLON 2 capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 mm. PillCam® COLON 2 is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID® software to compile the video data and enable the physician to review and report the results of the PillCam study.
The risks of PillCam capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON capsule endoscopy presents additional risks, including risks associated with drug products used to prepare the patient for the procedure, which are currently used for colonoscopy, including allergies or other known contraindications to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion. 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, and 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.