Given Imaging Announces Data Confirming PillCam(R) SB Can Improve Management And Outcomes In Patients With Crohn's Disease

SAN DIEGO, Oct. 15, 2013 (GLOBE NEWSWIRE) -- Given Imaging (Nasdaq:GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced new studies validating PillCam SB's role in improving care, management and outcomes for patients with known or suspected Crohn's disease. The studies were presented at the American College of Gastroenterology's Annual Scientific Meeting and Postgraduate Course (ACG), taking place October 11-16, 2013, at the San Diego Convention Center, San Diego, CA, where Given Imaging is exhibiting at booth #1200 throughout the conference.

"PillCam SB is one of the most important tools we have for detecting and monitoring small bowel diseases, such as Crohn's disease. Due to the evolving nature of Crohn's disease, it's crucial that we monitor mucosal healing, as well as disease progression, so that we are able to continually improve the targeting of our treatment regimens," said Neel K. Mann, M.D., Associate Director, Small Bowel Enteroscopy, Cedars-Sinai Medical Center. "The compelling new data being presented at this year's ACG meeting shows that PillCam SB can help us reclassify disease phenotype to create a more tailored and effective management plan for each patient."

Several ACG poster presentations highlighted the clinical benefit of PillCam SB in Crohn's patients as a safe and valuable tool in disease evaluation and management, including:
  • "Capsule Endoscopy (CE) Can Improve Outcomes in Crohn's Disease: An Evaluation of Pre- and Post-treatment CE," poster 426, presented by Neel K. Mann, M.D. and Simon K. Lo, M.D., Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, Calif. The aim of this retrospective study was to assess small bowel mucosal healing based on the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI, Dig Dis Sci (2008) 53:1933-27) after initiation or escalation of therapy. CE results led to an escalation of therapy or switching of biologic agents in 53.6% of patients. There was a statistically significant difference in the CECDAI between the pre- and post-treatment CE (p=0.0250.) The study's authors concluded that PillCam SB helped to re-classify disease phenotype in more than 60% of patients with suspected Crohn's disease or unclassified Inflammatory Bowel Disease, thereby potentially changing the management as well as the natural outcomes of small bowel Crohn's disease. More importantly, capsule endoscopy demonstrated mucosal healing in 70% patients, after assessment of therapy, positively changing disease outcome and achieving therapeutic goals in patients with non-stricturing phenotype Crohn's disease.  
  • "Clinical Impact of Capsule Endoscopy in Patients with Established Crohn's Disease," poster 1720, presented by researchers at McGill University Health Center, Montreal, QC, Canada, examined the impact of PillCam SB on the management of patients with established Crohn's disease. The results of this retrospective cross-sectional study of patients with established Crohn's disease showed that as a result of PillCam SB findings, 67% of patients had a change in management, including escalation in therapy, referral for surgery, de-escalation of anti-inflammatory therapy or initiation of therapy for concomitant IBS.  Investigators concluded that PillCam SB, a safe and valuable tool in disease evaluation and management, had a significant impact on managing treatment options for patients with established Crohn's disease.  
  • To help assess the value of monitoring in therapeutic management for Crohn's disease, Given Imaging supported researchers from the University of Chicago, Chicago Ill. and Cedars Sinai Medical Center, Los Angeles, Calf. in a national survey of gastroenterologists.  An analysis of this survey was presented by Adam C. Stein, M.D. in poster 420, "Mucosal Healing in Inflammatory Bowel Disease: A Nationwide Survey of Gastroenterologists' Current Practice Patterns".  The survey was conducted among community and academic gastroenterologists to determine current practice patterns for both achieving and maintaining mucosal healing in Crohn's and Ulcerative Colitis.  Results showed that the majority of surveyed gastroenterologists agreed that mucosal healing is the primary management goal in patients with both Crohn's and Ulcerative Colitis, and 57.1% indicated they would perform periodic endoscopy for disease monitoring even after mucosal healing was achieved and the patient was asymptomatic, or to assess for post-operative recurrence in Crohn's disease after ileocectomy with primary anastomosis.

About Crohn's Disease

Crohn's disease is a chronic condition that causes inflammation in the lining of the small intestine wall and can affect any part of the digestive tract. Symptoms can include diarrhea, abdominal pain, weight loss and rectal bleeding. Other cases of Crohn's may affect one or more of the following: the colon only, the small bowel only (duodenum, jejunum and/or ileum), the stomach or esophagus. 1 Roughly 500,000 Americans suffer from Crohn's disease, and about 20% have a direct relative with some form of inflammatory bowel disease (IBD). 2 Crohn's disease affects men and women equally. The cause is unknown; but, the most popular theory is that the immune system is reacting to a virus or bacterium that causes inflammation. 3 Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease. 4

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 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 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.

(1) http://www.ccfa.org/info/about/crohns Inflammatory Bowel Disease Frequently Asked Questions.

(2) Crohn's and Colitis Foundation of America (ccfa.org)

(3) National Institute of Diabetes and Digestive and Kidney Diseases (niddk.nih.gov)

(4) http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html
CONTACT: For further information contact:         Chantal Beaudry/Martyna Gawrych         Lazar Partners Ltd.         cbeaudry@lazarpartners.com         mgawrych@lazarpartners.com         212-867-1762                  Investor Contact:         David Carey         Lazar Partners Ltd.         dcarey@lazarpartners.com         212-867-1762                  Israel Investor Contact:         Nava Ladin         Gelbart Kahana Investor Relations         +972-3-6074717         nava@gk-biz.com

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