July 9, 2008
Study Shows That PillCam(R) SB Helps Doctors Treat Children With Crohn’s Disease More Effectively
Given Imaging Ltd. (NASDAQ: GIVN) (TELAVIV: GIVN) today announced a study published in the July issue of the Journal of Pediatric Gastroenterology and Nutrition found PillCam capsule endoscopy of the small bowel may enable more targeted and effective therapies for children with Crohn's disease. According to the study, the opportunities for improved treatment regimens were a direct result of reclassifying inflammatory bowel disease (IBD) from ulcerative or indeterminate colitis to definitive Crohn's disease and from uncovering a more significant burden of small bowel disease for those children already diagnosed with Crohn's disease.
The retrospective cohort analysis was conducted by Stanley Cohen, M.D., of the Children's Center for Digestive Healthcare in Atlanta, Georgia.
"PillCam SB is a valuable tool that allows gastroenterologists to make better medical decisions and tailor pharmacological management, resulting in improved patient outcomes for those who suffer from IBD," said Dr. Cohen. "Information obtained through PillCam SB capsule endoscopy can enable us to reclassify disease or understand the full extent to which the disease is affecting patients, thus facilitating more targeted and effective treatment regimens."
The retrospective cohort analysis examined the medical records of patients from ages two to 18 years of age who had been previously diagnosed with Crohn's disease, ulcerative colitis or indeterminate colitis and whose disease had flared within the previous three years, leading to capsule endoscopy. Twenty-eight (28) patients met the criteria for inclusion in the study. Key findings include:
-- 71% (5/7) of patients with ulcerative or indeterminate colitis had small bowel CE findings that led to reclassification of disease (from ulcerative or indeterminate colitis to Crohn's disease), resulting in a change in medical management. -- 62% (13/21) of patients with Crohn's disease were found to have more extensive (more proximal) small bowel disease than previously identified, 92% of which occurred in the jejunum, suggesting that pediatric Crohn's disease may involve the proximal small bowel more than previously reported. -- Of those with previously unrecognized jejunal disease, 92% (11/12) of treatment regimens were altered based upon the new CE findings.
The study authors also noted an additional benefit of CE was to help patients and their parents better understand the disease process and rationale for therapeutic recommendations.
The PillCam SB 2 video capsule, when used with the PillCam Platform, is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up. The PillCam SB 2 video capsule and PillCam Platform are not cleared for use in children under 10 years of age and should not be used outside of the context of approved clinical trials with such patients.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam(R) Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID(R) software. Given Imaging has a number of available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 700,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ: ELRN) (TELAVIV: ELRN). For more information, visit http://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) satisfactory results of clinical trials with PillCam COLON (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 future litigation, including patent litigation with Olympus Corporation, (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, and (11) 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, 2007. 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.
For further information contact: Fern Lazar Email Contact David Carey Email Contact Lazar Partners Ltd. 1-866-GIVEN-IR
SOURCE: Given Imaging