Healthcare Industry News: Olympus
News Release - June 12, 2007
Given Imaging Announces Highlights of Sixth International Conference on Capsule Endoscopy(TM)YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Jun 12, 2007 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced highlights from the 6th International Conference on Capsule Endoscopy(TM) (ICCE(TM)), which took place in Madrid, Spain, June 8 - 9, 2007. Jacques Devière, M.D., ULB Hôpital Erasme, Brussels, Belgium and Juan A. Ramirez-Armengol, M.D., Hospital Clínico San Carlos, Madrid, Spain co-chaired the meeting that included more than 80 abstracts, posters and case studies presented by gastroenterologists from 34 countries on capsule endoscopy in the small bowel, colon and esophagus.
"ICCE Madrid is an opportunity for physicians to share the latest scientific and clinical data, as well as practical information about new applications of capsule endoscopy," said Roberto de Franchis, Professor of Medicine at the University of Milan, Italy and Honorary President of ICCE. "Among the most interesting presentations were those that validated capsule endoscopy's ability to change patient management and, subsequently, clinical outcomes through earlier detection and definitive diagnosis of gastrointestinal cancers, Crohn's disease and life-threatening sources of bleeding."
Among the highlights at this year's ICCE were studies presented on:
Colon capsule endoscopy
In a session entitled "Scientific Evidence of PillCam Colon CE," co-chair Jacques Devière, presented the interim results of a European multi-center clinical trial of 329 patients to assess the yield of PillCam Colon capsule endoscopy (Colon CE) in detecting polyps and other pathologies compared to traditional colonoscopy. Patients included in this study were known to have or suspected of having colonic disease and were referred for colonoscopy. Patients went through a traditional PEG colon prep and ingested the capsule in the morning. The procedure included prokinetic agents and additional small doses of laxatives. Independent physicians performed capsule imaging analysis and traditional colonoscopy ("gold standard") after excretion. Significant findings were defined as at least one polyp greater than or equal to 6 mm or greater than or equal to 3 polyps of any size. Based on an interim analysis of results in 84 patients, the study's authors concluded that Colon CE showed encouraging sensitivity and negative predictive values for detection of significant findings compared to colonoscopy, and if these data are further validated at the conclusion of this study, this new non-invasive technology might challenge colonoscopy for CRC screening and polyps detection.
Researchers at the CHU de Nancy, Internal Medicine and Digestive Pathology, France led by Michel Delvaux M.D., conducted a study to compare the clinical characteristics of patients with chronic iron-deficiency anemia (CIDA) and patients with occult gastrointestinal bleeding (OGB) and to evaluate the diagnostic yield of capsule endoscopy (CE) in patients with CIDA. Two groups of patients were selected from a cohort of 604 consecutive patients investigated with CE between 01/2002 and 12/2006. Based on the results of the study, the study authors concluded that while CE has a high diagnostic yield in patients with CIDA, it has a higher yield in patients with OGB suggesting that CE should be performed early in the work of patients with CIDA to help to direct further investigations.
Inflammatory Bowel Disease
An interim analysis of a multi-center Australian study of CE in suspected small bowel Crohn's Disease (SB CD) led by Warwick Selby, M.D. of Royal Prince Alfred Hospital Sydney, sought to determine the diagnostic ability and clinical impact of CE for suspected SB CD in symptomatic patients with a non-diagnostic standard work-up including colonoscopy and SB follow-through within 6 months of enrollment. Of the 51 patients who had completed the study to date, a preliminary analysis of entry criteria showed that CE was able to diagnose SB CD in 22% of subjects. Raised inflammatory markets or anemia made a diagnosis of CD more likely. These results need to be confirmed by analysis of the full cohort.
Fifty-three Australian physicians participated in a national registry established by the Gastroenterological Society of Australia and the Australian Capsule Endoscopy Interest Group to determine the long-term diagnostic benefit, safety and cost-effectiveness of capsule endoscopy in patients with obscure GI bleeding (OGIB). The participating physicians performed 2,949 CE procedures on patients who had previously undergone upper endoscopy and colonoscopy. Prior to undergoing the CE procedure, the patients had undergone an average of 3.6 diagnostic procedures, including 1.6 endoscopies and 1.5 colonoscopies. The average cost of these procedures was A$3,282. In addition, 37% of patients were admitted to the hospital in the 12 months before capsule endoscopy. During the study period, the cost-per-patient decreased 21%. In a follow up of 420 studies, the cost of investigation decreased to A$324, and only 11% of patients required hospital admission. The study confirmed the high diagnostic yield of CE for OGIB in a large patient population and confirmed safety and cost effectiveness.
Victor Fox, M.D. of Children's Hospital in Boston, Massachusetts conducted a 27-patient study to determine the feasibility of using PillCam ESO in children and young adults with esophageal varices, a dangerous complication of liver cirrhosis and portal hypertension that can lead to life-threatening bleeding. The study concluded that PillCam ESO is a feasible alternative to conventional endoscopy for screening and surveillance of esophageal varices.
Physicians at the Mayo Clinic College of Medicine, department of Gastroenterology and Hepatology, Scottsdale, Arizona conducted a meta-analysis of eleven studies including approximately 749 patients comparing the diagnostic yield of capsule endoscopy and double-balloon enteroscopy (DBE) in patients with suspected small bowel disease. Physicians concluded that capsule endoscopy and DBE had a comparable diagnostic yield, and that capsule endoscopy should be the diagnostic test of choice due to its non-invasive nature.
Started in 2002, the International Conference on Capsule Endoscopy(TM) is the main forum for leading gastroenterologists and key opinion leaders to exchange scientific, clinical and practical information about capsule endoscopy. For more information visit www.icce.info
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® 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® software. Given Imaging has three commercially 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; and the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. More than 500,000 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 direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. 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) the reimbursement policies for our product from healthcare 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, 2006. 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.
Source: Given Imaging
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