Given Imaging Announces New Studies That Affirm PillCam SB as the Gold Standard for Detecting and Diagnosing Small Bowel Diseases

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| Source: Given Imaging Ltd.

BERLIN, Oct. 15, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced results from four studies confirming PillCam SB as the gold standard for detecting diseases of the small bowel. The studies were presented at United European Gastroenterology Week (UEG Week) taking place October 12-16, 2013 in Berlin, Germany where Given Imaging will be exhibiting throughout the conference at Booth #7, located in Hall 15.1.

Key findings from PillCam SB studies presented at UEG Week included:

  • PillCam SB led to a new diagnosis in over 40% of IBD cases
     
  • PillCam SB provides relevant findings in over 50% of patients who underwent capsule endoscopy for unexplained Iron Deficiency Anemia after negative upper and lower GI endoscopy
     
  • Emergency use of PillCam SB in patients with signs of acute upper/mid gastrointestinal bleeding whose gastroscopy exams were negative detected the bleeding source and helped guide further therapy
     
  • PillCam SB is a useful and safe diagnostic modality in children with suspected small-bowel diseases in the largest cohort of pediatric patients

"In the area of small bowel evaluation, PillCam SB is widely used by the GI community and is considered a highly accurate diagnostic modality," said Fevronia Kiparissi M.D., Department of Gastroenterology, Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom. "The studies being presented at UEG Week demonstrate PillCam's potential to improve diagnostic yield and change the course of treatment in cases where other modalities failed to identify conditions of the small bowel leading to better outcomes for patients suffering from inflammatory bowel disease, gastrointestinal bleeding, or iron deficiency anemia. This is especially valuable for pediatric patients which we have been following-up for many years."

"The Diagnostic Value in Pediatric Small Bowel Assessment by Wireless Capsule Endoscopy: A Tertiary Center Experience," poster P1333: presented by Efstratios Saliakellis M.D., and colleagues, Great Ormond Street Hospital, NHS Foundation Trust, London, United Kingdom, assessed the diagnostic value, tolerance and safety of PillCam in pediatric patients. The retrospective review of PillCam capsule endoscopy (CE) in 291 children showed over 60% had positive findings and 34% were diagnostic in terms of establishing a diagnosis or altering the therapeutic approach in the patient. The results, which represent the largest cohort of pediatric patients and include the youngest child ever to undergo capsule endoscopy, demonstrated that with careful selection, CE is a useful and safe diagnostic modality in children with suspected small bowel diseases.

"Why Should We Still Use Capsule Endoscopy in Inflammatory Bowel Disease," oral presentation OP430: presented by Lucia Marquez M.D., and colleagues, Hospital del Mar, Digestive Diseases, Barcelona, Spain, analyzed the impact of PillCam capsule endoscopy (CE) on the diagnosis and management of suspected or established Inflammatory Bowel Disease (IBD). Results confirmed that CE findings led to a new diagnosis in over 40% of cases and that CE is a useful tool for diagnosis of new IBD as well as for guiding treatment.

"Findings and Long Term Outcomes for Patients Following Video Capsule Endoscopy to Investigate Iron Deficiency Anemia," poster P1336: presented by Janisha Patel M.D., and colleagues, Kings College Hospital, Dept. of Hepatology, London, United Kingdom, observed long term outcomes in patients who have undergone capsule endoscopy to investigate iron deficiency anemia (IDA). The results of this retrospective study analyzing long term outcomes of 115 patients who had a negative upper and lower GI endoscopy, showed capsule endoscopy (CE) presented relevant findings in over 50% of patients who underwent CE to investigate unexplained IDA and a significant number of these patients were then actively treated.

"Emergency Video Capsule Endoscopy in Patients with Acute Gastrointestinal Bleeding, poster," poster P1332:presented by Christoph Schlag M.D., and colleagues, Technical University Munich, Munich, Germany, analyzed the use of PillCam capsule endoscopy (CE) for acute gastrointestinal bleeding in the emergency setting. Of the patients who failed to have their source of bleeding identified with gastroscopy, 93% showed complete examination using emergency CE and 73% had the bleeding source identified with CE.  Results confirm that for patients with signs of acute upper/mid gastrointestinal bleeding who have had a negative gastroscopy, emergency CE can be used to immediately detect the bleeding source and to guide therapy.

About UEG Week

UEG Week is the largest and most prestigious gastroenterology meeting in Europe and has developed into a global congress. It attracts over 14,000 participants each year, from more than 120 countries, and numbers are steadily rising. UEG Week provides a forum for basic and clinical scientists from across the globe to present their latest research in digestive and liver diseases, and also features a two-day postgraduate course that brings together top lecturers in their fields for a weekend of interactive learning.

About PillCam® SB

The PillCam SB capsule is a minimally invasive procedure to visualize and monitor small bowel abnormalities associated with Crohn's disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its third generation, PillCam SB 3 contains an imaging device and light source and transmits images at a rate between two and six images per second. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB 3 builds on Given Imaging's unique expertise and collaborative efforts as an industry leader that includes more than 2 million uses of PillCam capsules in patients worldwide and more than 1,900 clinical studies.

The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. 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

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.

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