SOURCE: Given Imaging

Given Imaging

May 22, 2012 11:00 ET

Given Imaging Announces Significant New Data on PillCam® SB at DDW

Studies Investigate Use in Targeted Patient Populations; Data Also Confirm Clinical Benefits of Key Technological Advances including QuickView + Suspected Bleeding Indicator, Motility Algorithm and the Extended Operating Time Capsule for Select Patient Groups

SAN DIEGO, CA--(Marketwire - May 22, 2012) - Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced new data on recommendations for early use of PillCam SB, as well as new technological advances. Given Imaging also announced new studies confirming PillCam® SB's benefits in several specialized patient populations, including octogenarians and those with neutropenic cancer, for whom the minimally-invasive procedure might be a safer alternative to other diagnostic methods. The studies are being presented at the American Society for Gastrointestinal Endoscopy (ASGE) Research Forum at Digestive Disease Week® (DDW), taking place May 19 - 22 in San Diego.

Data on Earlier Use of PillCam SB

  • "Improved Diagnostic Yield With Early Video Capsule Endoscopy After Diagnosis of Obscure Gastrointestinal Bleeding" (216)

    Investigators led by Dhavan A. Parikh, Department of Internal Medicine, UC Davis, Sacramento, CA conducted a retrospective analysis of 410 consecutive VCE studies from a single reader to determine the optimal timing of capsule endoscopy for the evaluation of OGIB. Based on their findings, they concluded that VCE should ideally be performed within one week of OGIB diagnosis to maximize diagnostic yield. Video capsule endoscopy within 48 hours is preferable to prevent a delay in diagnosis.

  • "Immediate Capsule Endoscopy or Angiogram in Patients With Acute Obscure Gastrointestinal Bleeding: a Prospective Randomized Study With Long Term Follow up" (150)

    Wai Keung Leung, M.D., of the Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong led a prospective randomized study that compared capsule endoscopy with angiogram in patients with acute overt OGIB to compare the diagnostic yield and long term outcome of patients of each method. Investigators concluded that capsule endoscopy has a higher diagnostic yield than angiogram in patients with acute overt OGIB, supporting the early use of CE as the first line investigation for patients with active OGIB.

Data on Specialized Patient Populations

  • "Capsule Endoscopy in Octogenarians: Analysis of a Large Prospectively Collected Database" (Sa1742)

    Investigators led by Victoria Gomez, M.D., Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL studied PillCam SB in 188 patients over 80 years old to evaluate its safety and efficacy in this distinct patient group who often present with iron deficiency anemia (IDA), overt and occult obscure gastrointestinal bleeding (OGIB). There is limited published data on the outcomes and findings of CE in patients, particularly over the age of 80. The authors concluded that capsule endoscopy is safe to use in the older patient population, with very low capsule retention rate and a very good diagnostic yield.

  • "Safety and Efficacy of Wireless Capsule Endoscopy in Cancer Patients With Low Neutrophil Counts and Obscure Gastrointestinal Bleeding: a Case Controlled Study" (Sa1745)

    Nirav Thosani, M.D., of the Department of Gastroenterology, Hepatology and Nutrition, The University of Texas, Houston Medical School, Houston, studied the safety and diagnostic yield of wireless capsule endoscopy (WCE) in neutropenic cancer patients with obscure gastrointestinal bleeding (OGIB) through a retrospective review of 426 cancer patients who underwent WCE at the M.D. Anderson Cancer Center from July 2005 to September 2011. Their results showed that WCE is a safe and effective tool in cancer patients with low neutrophil counts and OGIB, with an overall diagnostic yield of 72%.

New Technological Advances

  • "Evaluation of the QuickView and Suspected Blood Indicator Modes for Primary Capsule Endoscopy Reading in Active Small Bowel Bleeding" (217)

    Led by Anoop Appannagar, M.D., Department of Medicine, University of Chicago Medical Center, Chicago, IL, investigators studied the performance of PillCam SB's QuickView (QV) plus Suspected Blood Indicator (SBI) features compared to the standard view software to determine sensitivity of the new features. The group reviewed all WCE studies performed for suspected small bowel bleeding from 4/2007 to 3/2011 and concluded that in patients with active small bowel bleeding, the QV+SBI reading format of WCE is highly sensitive with a 100% NPV and can be performed in a short amount of time. QV+SBI also provided excellent inter-observer agreement in novice readers with minimal training. These findings may justify a clinical algorithm for evaluating suspected small bowel bleeding that utilizes WCE and immediate QV+SBI. A positive finding directs immediate therapy, while a negative study may require re-review with SV or additional testing.

  • "The Twelve-Hour Battery Given Wireless PillCam SB2ex Improves Overall Cecal Intubation Rate and Increases the Positive Yield" (153)

    Neel K. Mann presented a single center study evaluated the 12-hour Given WCE PillCam SB2EX in cecal intubation rates in both inpatients and outpatients to see if the longer battery time could improve cecal intubation rates (currently averaging 80% with the 8-hour Given wireless PillcamSB2). Investigators completed a retrospective review of a total of 108 patients who received a 12-hour capsule and 147 patients who received an 8-hour capsule between November 2010 - November 2011 and determined that a 12-hour battery capsule may improve cecal intubation rate and cecal transit time, especially in the inpatient setting. Investigators also reported a higher yield of clinically relevant findings.

About PillCam® SB
The PillCam® SB video capsule 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 Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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® video capsules for the small bowel, esophagus and colon [PillCam® COLON not approved for use in the United States.], industry-leading ManoScan™ high-resolution manometry and Bravo® pH and Digitrapper® pH and impedance monitoring. 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 and Hong Kong. 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. 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, 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 for the Company's ongoing obligations to disclose material information under the applicable securities laws, it 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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