SOURCE: Given Imaging

Given Imaging

September 14, 2010 16:05 ET

New Studies From the Inaugural International Conference on Small Bowel Capsule Endoscopy and Double Balloon Endoscopy Emphasize the Value of the PillCam® Platform

More Than 600 International Thought Leaders in Gastroenterology Meet in Paris to Discuss Capsule Endoscopy

Feasibility Study Confirms Emergency Room Use of PillCam® ESO for Acute Upper GI Hemorrhage

YOQNEAM, ISRAEL--(Marketwire - September 14, 2010) -  Given Imaging (NASDAQ: GIVN) today announced highlights from the inaugural International Conference on Capsule Endoscopy and Double Balloon Endoscopy (ICCD) which took place in Paris, France, on August 27 and 28, 2010. The scientific conference was co-sponsored by Given Imaging and Fujinon GmbH (Europe) and was attended by more than 600 international thought leaders in the field of gastroenterology -- the largest meeting ever to focus on these growing market segments. The scientific sessions focused on novel capsule endoscopic approaches to clinical problems from the esophagus through the colon and provided physicians with the opportunity to discuss current research, best practices and future indications of small bowel diagnostics and therapeutics. One hundred twenty-three scientific abstracts were presented, including 24 oral presentations, 61 poster presentations and five video forums.

"The inaugural International Conference on Capsule Endoscopy and Double Balloon Endoscopy underscores the clinical impact capsule endoscopy and double balloon endoscopy have made in helping physicians diagnose and treat patients suffering from gastrointestinal diseases," said ICCD conference Chairman, Professor Gérard Gay of Central University Hospital Nancy in France. "As leading GI physicians continue to advance these technologies, patients and their families will ultimately benefit."

"We have been honored by the positive support for our PillCam Platform from the physician community throughout the past ten years," said Homi Shamir, President and CEO of Given Imaging Ltd. "The gathering of more than 600 leading gastroenterologists at this international forum to discuss our technology provides us with the opportunity to advance the science to ensure we continue to provide physicians and patients with innovative, patient-friendly and clinically significant tools to visualize the gastrointestinal tract." 

Key highlights from the conference include:

PillCam® SB

Obscure Gastrointestinal Bleeding -- PillCam Results Predict Patient Outcomes

In a study entitled, "Negative Capsule Endoscopy Predicts Low Re-bleeding Rate and Mortality in Obscure Gastrointestinal Bleeding (OGIB): Results from Long-term Follow-up," (COCS No. 35), researchers from The Chinese University of Hong Kong investigated the performance of capsule endoscopy in predicting the long-term outcome of OGIB patients. One hundred and three OGIB patients were followed for a median of 50 months after their capsule endoscopy procedure to determine the likelihood of re-bleeding and mortality, the overall rates of which were higher in capsule-positive patients. The study authors concluded that PillCam endoscopy could also identify patients with low likelihood of re-bleeding and with a low mortality rate. Patients under age 65 with a hemoglobin level above 8 g/dL and negative CE were in this category, while elderly patients and those with low hemoglobin levels had a significant incidence of recurrent bleeding and death. These results support the utility of PillCam in managing patient outcomes. 

Researchers from The Jikei University School of Medicine in Tokyo, Japan, presented a poster entitled, "Optimal Time Frame for Performing Capsule Endoscopy in the Investigation of Overt Obscure Gastrointestinal Bleeding," (COCS No. 43). One hundred and fifty seven patients underwent capsule endoscopy to determine the optimal reading time frame for performing capsule endoscopy in patients with small bowel bleeding. The study authors concluded capsule endoscopy should be performed within six days after an episode of small bowel bleeding to significantly increase the likelihood of detecting the bleeding focus.

Crohn's Disease -- PillCam Endoscopy Improves Diagnosis and Patient Management Strategies

Researchers from the Skane University Hospital in Malmo, Sweden, presented a study entitled, "Clinical Value of Video Capsule Endoscopy in Patients with Perianal Crohn's Disease," (COCS No. 72). The study examined the role of capsule endoscopy in determining disease extent, as well as the impact of capsule endoscopy on the clinical management of patients with primary perianal Crohn's disease in 41 patients. The investigators found substantial evidence of disease outside the anal area, including within the small bowel. They concluded that capsule endoscopy was not only useful, but that it may have a significant impact on the diagnosis and management of patients with perianal Crohn's disease.

In a study entitled, "Detection of Crohn's Disease in Spondyloarthropathy (SpA) by Capsule Endoscopy Compared to Colonoscopy: Preliminary Results of the Space Study," (COCS No. 79), Dr. F. Costea, Dr. Michael Starr and Dr. Ernest Seidman, from McGill University in Canada determined the prevalence of Inflammatory Bowel Disease in SpA patients, comparing capsule endoscopy to ileocolonoscopy. Spondyloarthropathy is an inflammatory joint disease similar to rheumatoid arthritis. Coexistent Crohn's disease may occur in up to 40 percent of patients with SpA. Preliminary results from 15 of the 80 projected SpA patients concluded that capsule endoscopy of the small bowel is superior to colonoscopy in detecting Crohn's disease in patients with known SpA. These findings are important because they assist in choosing the appropriate drugs to treat the SpA in patients with underlying IBD.

PillCam® COLON

Physicians presented two encouraging case studies for PillCam COLON 2, and ongoing European studies were referenced. Data from these ongoing trials should be discussed at future gastroenterology meetings. Doctors also presented results from a number of studies that used the first-generation PillCam COLON, including one that validated PillCam COLON's use in diagnosing colon pathology and another that determined its value in managing patients with inflammatory bowel disease.

PillCam ESO

Upper Gastrointestinal Bleeding -- Improved Outcomes with UGI Bleeding and Varices

Dr. Ian Gralnek of the Rambam Medical Center, presented a study entitled, "A Feasibility Study Evaluating Capsule Endoscopy (CE) in Persons Presenting with Acute Upper Gastrointestinal Hemorrhage (UGIH)" (COCS No. 54). The preliminary data from 33 patients presenting in an emergency setting with Acute Upper Gastrointestinal Hemorrhage demonstrated that PillCam ESO is a safe and feasible test in this patient population. Traditional evaluation of bleeding by insertion of a nasogastric tube appeared to be of little value. Additionally, PillCam ESO appears to differentiate variceal and non-variceal bleeding as compared to EGD. These results are similar to previous positive results in similar patient populations.

In study COCS No. 103, entitled, "Diagnostic Accuracy of PillCam ESO 2 in Patients with Known or Suspected Esophageal Varices: Preliminary Data," researchers from the Virgen Macarena University Hospital in Spain presented preliminary data investigating the utility of PillCam ESO in the diagnosis and grading of esophageal varices. In the sixteen patients included to date, the diagnostic yield of PillCam ESO for detecting and grading esophageal varices is comparable to upper gastrointestinal endoscopy. PillCam ESO correctly indicated a need for primary prophylaxis in 100 percent of cases.

About Obscure GI Bleeding
Occult gastrointestinal bleeding (OGIB) occurs when blood is lost from the digestive tract without visible, or overt, signs of bleeding.(1) The condition is usually discovered only with positive results for a fecal occult blood test or through detection of iron deficiency anemia, and there are many potential causes. In approximately half of patients with OGIB, the source of bleeding is unexplained.(2)

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. Roughly 50 percent of all cases of Crohn's disease are diagnosed in the last part of the small intestine (the terminal ileum) and cecum. This area is also known as the ileocecal region. 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.(3) Roughly 500,000 Americans suffer from Crohn's disease, and about 20 percent have a direct relative with some form of inflammatory bowel disease (IBD).(4) It 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.(5) Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease.(5)

About Upper GI Bleeding
Upper GI bleeding can result from a variety of causes, including peptic ulcer disease, hemorrhagic gastritis, gastroesophageal varices and Mallory-Weiss syndrome, and is defined as bleeding above the ligament of Treitz, between the duodenum and jejunum. Regardless of the cause of bleeding, a rapid clinical assessment is critical. Acute upper GI bleeding is one of the most common medical emergencies, responsible for approximately 300,000 hospitalizations each year with a mortality rate close to 10 percent.(6)

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 1,200 peer-reviewed studies. It is the most accurate, patient-friendly tool for visualization of the small bowel in patients two years and older and is used by physicians to evaluate patients with obscure GI bleeding, including iron deficiency anemia, suspected Crohn's disease, suspected small intestinal tumors, monitoring patients with polyposis syndromes and in suspected or refractory malabsorptive syndromes, such as celiac disease. PillCam® SB is the gold standard in small bowel evaluation.

About PillCam COLON
PillCam COLON 2 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. Employing intelligent functionality, PillCam COLON 2 transmits 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. PillCam COLON 2 received a CE Mark in 2009 and became commercially available in Europe in January 2010.

About PillCam ESO
PillCam ESO was cleared by the U.S. Food and Drug Administration in November, 2004, to visualize the esophagus in adult patients in a patient-friendly way. Now, in its second generation, PillCam ESO 2 contains imaging devices and light sources at both ends of the capsule that capture up to 18 images per second as it passes down the esophagus in a thirty-minute procedure.

About ICCD
The inaugural International Conference on Capsule Endoscopy and Double Balloon Endoscopy joined two meetings held in previous years focused on capsule endoscopy and double balloon endoscopy. The ICCD meeting combines state-of-the-art lectures and original studies to provide a forum for international thought leaders in the field of gastroenterology to discuss current research, best practices and future indications of capsule endoscopy and double balloon endoscopy. The inaugural event was held in Paris, France in August, 2010, and was sponsored by Given Imaging Ltd and Fujinon (Europe) GmbH. For more information please visit, www.iccd2010.com.

About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal visualization by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam® capsule endoscopy uses cutting-edge, wireless technology and advanced software to provide physicians with natural images of the small intestine via PillCam® SB, the esophagus through PillCam® ESO and the colon with PillCam® COLON [PillCam® COLON is not cleared for use in the USA]. The PillCam® capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). In April, 2010, Given Imaging acquired Sierra Scientific Instruments, the leading provider of specialty GI diagnostic solutions and pioneer of high-resolution manometry for assessing gastrointestinal motility. Sierra Scientific is now a wholly-owned subsidiary of Given Imaging. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia and Singapore. 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. 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 and (18) 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, 2009. 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.

(1) http://www3.utsouthwestern.edu/endocrine/Rockey.htm

(2) http://www.aafp.org/afp/20040215/875.html

(3) qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease Frequently Asked Questions.

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

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

(6) Krumberger, Joanne M. RN, MSN, FAAN. How to manage an acute upper GI bleed. RN/Thomson AHC Home Study Program CE CENTER. March 1, 2005. http://rn.modernmedicine.com/rnweb/article/articleDetail.jsp?id=150046

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