SOURCE: Given Imaging

Given Imaging

June 03, 2009 13:33 ET

New Clinical Study Shows Over Half of Eligible OGIB Patients May Benefit From Small Bowel Capsule Endoscopy as Recommended by GI Society Guidelines

Additional Studies Provide Evidence for Broader PillCam® SB Use in IDA and Small Bowel Crohn's Disease; Given Imaging Introduces Product and Software Advances to PillCam® Platform

CHICAGO, IL--(Marketwire - June 3, 2009) - Given Imaging Ltd. (NASDAQ: GIVN) today announced a new study that shows over half of the eligible patients with occult or obscure gastrointestinal bleeding (OGIB) may benefit from the additional diagnostic information provided by small bowel capsule endoscopy in accordance with existing gastrointestinal (GI) society guidelines, which call for the patient-friendly, non-invasive procedure following a negative upper endoscopy and colonoscopy. Additional studies advocate broader utility of capsule endoscopy in iron deficiency anemia (IDA) and suspected small bowel Crohn's disease. The studies were presented at the Digestive Disease Week® (DDW) 2009 conference taking place in Chicago from May 30 - June 4, where Given Imaging also demonstrated a new, simplified procedure for performing PillCam® capsule endoscopy of the small bowel and the latest version of its RAPID® Software Suite at booth #2235 at the conference.

In presentation #299, Professor Ian M. Gralnek, of the Technion-Israel Institute of Technology and Rambam Medical Center, Haifa, Israel, concluded that based on an analysis of a US-based, multi-payer medical claims database that analyzed the records of 2.7 million adults suspected of GI bleeding, less than half of patients with OGIB and a negative endoscopic workup had received a diagnostic capsule endoscopy procedure in accordance with guidelines set by GI societies, including the American Society for Gastrointestinal Endoscopy and the American Gastroenterological Association, and the British Society of Gastroenterology. This study also found extensive use of contrast radiography, an x-ray or gamma-ray based test.

"Capsule endoscopy is recognized as the diagnostic standard of care for OGIB, but many patients are undergoing multiple tests, such as contrast radiography, that are less conclusive and expose them to additional radiation," said Professor Gralnek. "Several studies also show that PillCam SB is a clinically and economically effective tool among patients with IDA and those with suspected small bowel Crohn's disease."

Additional studies presented at DDW provide evidence for broader use of PillCam SB in IDA and suspected small bowel Crohn's disease:

--  A poster presentation (#W1082) led by Professor Gralnek that analyzed
    a US-based, multi-payer medical claims database and found a high use of
    contrast radiography studies in the evaluation of patients with unexplained
    iron deficiency anemia (IDA) despite current published data demonstrating
    the diagnostic value of capsule endoscopy. Of 37,338 patients with a
    potential need for small bowel capsule endoscopy, only 7,894 capsule
    endoscopy studies were performed (21 percent of expected) while 30,088
    received contrast radiography. Small bowel capsule endoscopy is recommended
    in males and selected females with IDA and negative upper endoscopy and
    colonoscopy.
    
--  A poster presentation (#W1084) led by Jonathan A. Leighton, of the
    Mayo College of Medicine in Scottsdale, Arizona concluded that capsule
    endoscopy is less costly than small bowel follow through (SBFT) for
    evaluating patients with suspected small bowel Crohn's disease. Using a
    decision analytic model, researchers compared estimated total costs for
    diagnosis and disease management for one year.
    
--  A poster presentation (#T1515) led by Professor Gralnek reports an
    extensive literature review utilizing the six most accepted evidence
    grading systems(1) and concluded that clinicians and policymakers have
    evidence to use capsule endoscopy for patients with suspected Crohn's
    disease.  The grading systems used in the study were developed to assist
    clinicians and policymakers in determining when sufficient evidence has
    accumulated to incorporate new technologies into clinical practice.
    

New, Simplified Procedure for PillCam® of the Small Bowel

In separate news, the company also demonstrated a simplified procedure for performing PillCam capsule endoscopy of the small bowel. First unveiled to nurses at the Society of Gastroenterology Nurses and Associates (SGNA) meeting which took place in St. Louis, from May 15 - 20, the simplified procedure that uses the new SensorBelt with the RecorderPouch and obviates the need to use the sensor array and recorder belt previously required.

The new procedure has been very well received, with nurses surveyed indicating that this new procedure would save them time and be welcomed by their patients. Specifically, the nurses also indicated that, on average, they would save 15 to 30 minutes of preparation and maintenance time per procedure. Both products can be washed or disinfected using common liquid disinfectants and are priced to enable cost-effective reorder. The RecorderPouch is available now while the SensorBelt is pending 510(k) clearance.

"This new procedure makes a patient-friendly diagnostic test even easier while improving workflow productivity at the same time," said Pat Moushey, RN, CGRN, St. Luke's Hospital, St. Louis. "The SensorBelt reduces the time required to prepare the patient for a capsule endoscopy and time spent on equipment preparation and maintenance. The RecorderPouch is less visible and allows greater freedom of movement for patients."

Next-Generation Software

The latest version of RAPID® Software Suite, which includes RAPID 6, RAPID® 6 Access and RAPID® 6 Reader, incorporates the following new features:

--  Image Adjustment with FICE (Flexible spectral Imaging Color
    Enhancement), developed by FUJIFILM, a partner of Given Imaging. FICE is an
    image-enhancing technology that aids the physician in viewing surface
    tissue characteristics and blood vessels by visually enhancing potential
    areas of disease;
--  PillCam Progress Indicator, which may aid in planning therapeutic
    intervention by providing an estimation of linear distance within the small
    bowel along with information concerning rate of capsule progress through
    the small bowel;
--  Mosaic View, which allows the reader to view an array of consecutive
    images showing how the tissue changes as the PillCam video capsule
    progressed;
--  An updated Study Manager and patient management screens including user-
    customizable fields, pull-down menus for easy, error-free data entry and an
    exportable database.
    

About Occult GI Bleeding

Occult gastrointestinal bleeding (OGIB) occurs when blood is lost from the digestive tract without visible, or overt, signs of bleeding.(2) 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.(3)

About IDA

Iron deficiency anemia (IDA) is a common type of anemia in which the patient lacks adequate healthy red blood cells.(4) Lack of iron in the blood affects the body's ability to carry oxygen and results in patients feeling tired, weak, irritable and lightheaded. The causes of IDA vary but can include loss of blood, pregnancy, inadequate diet, the inability to absorb iron from food and internal bleeding due to a bleeding ulcer, a colon polyp or colon cancer.(5)

About Crohn's Disease

Crohn's disease is a chronic condition that causes inflammation in the lining of the small intestine wall. It usually occurs in the lower part of the small intestine called the ileum, but 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.(6) 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).(7) 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.(8) An upper GI endoscopy, upper GI radiography series and colonoscopy are often used to test for inflammation and intestinal abnormalities. Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease.

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 close to 1,000 peer-reviewed studies. It is the most accurate, patient-friendly diagnostic and monitoring tool for visualization of the small bowel and is used by physicians to evaluate patients with obscure GI bleeding, including iron deficiency anemia, suspected Crohn's disease, suspected small intestinal tumors and monitoring patients with polyposis syndromes and in suspected or refractory malabsorptive syndromes, such as celiac disease. The PillCam® family of products are the gold standard in capsule endoscopy.

Research for studies #299 and W1082 were assisted by Given Imaging. Professor Ian Gralnek and Jonathan Leighton, M.D., are consultants to Given Imaging. Denise Malvehy is an employee of Given Imaging.

About Digestive Disease Week

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. 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, DDW takes place May 30 - June 4, 2009, at the McCormick Place, Chicago, IL. 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 2001 Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam SB, the esophagus through PillCam ESO and the colon with PillCam COLON [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). Given Imaging's products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to better diagnose diseases of the esophagus, small bowel and colon [PillCam COLON is not cleared for use in the USA.] and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. 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 http://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 receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of significant litigation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, (11) the impact of global economic conditions, and (12) 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, 2008. 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) Evidence grading systems used in the study were: the American College of Chest Physicians (ACCP), Australian National Health and Medical Research Council (ANHMRC), Oxford Centre for Evidence-Based Medicine (OCEBM), Scottish Intercollegiate Guidelines Network (SIGN), US Task Force on Community Preventive Services (USTFCPS) and US Preventive Services Task Force (USPSTF)

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

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

(4) http://www.mayoclinic.com/health/iron-deficiency-anemia/DS00323

(5) http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html

(6) http://qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease Frequently Asked Questions

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

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

Contact Information