Healthcare Industry News: colonoscopy
News Release - October 20, 2006
Results of First PillCam(TM) COLON Studies Published in EndoscopyYOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Oct 20, 2006 -- Given Imaging Ltd. (NASDAQ:GIVN ) today announced that the results of the first PillCam(TM) COLON clinical studies were published in the October Issue of Endoscopy, the official journal of The European Society of Gastrointestinal Endoscopy. Conducted independently by the Rambam Medical Center, Hillel-Yaffe Medical Center and Bikur Holim Hospital in Israel and Erasme University Hospital in Belgium, both studies determined PillCam COLON to be a promising new modality for colonic evaluation.
Jacques Devičre M.D., investigator on the COLON pilot study, professor of medicine at Brussels Erasme University Hospital and president elect of the European Society of Gastrointestinal Endoscopy, said, "While still early, these data provide compelling evidence that PillCam COLON could be used as one of the diagnostic tests used by doctors to visualize abnormalities of the colon."
"The ideal method to visualize the colon should be noninvasive, convenient, safe, well accepted by the target population, show high diagnostic accuracy and be cost-effective," said Rami Eliakim M.D., lead investigator of the Israeli multi-center study and chief of gastroenterology at Rambam Medical Center in Haifa, Israel. "If further study results confirm the recent data, PillCam COLON could represent a patient-friendly method for physicians to visualize the colon that could potentially lead to significantly wider patient compliance with guidelines."
About the Studies
Evaluation of the PillCam COLON capsule in the detection of colonic pathology; results of the first multi-center, prospective, comparative study
A total of 91 individuals were enrolled in three Israeli centers; the results were evaluable in 84 cases. The patients were all scheduled for traditional colonoscopies later in the day.
Polyps of any size were found in 45 patients by either of the screening methods. PillCam COLON identified 76% (n=34) compared to 80% (n=36) by colonoscopy. Out of the 84 patients, approximately 24% (n=20) had significant findings, defined as at least one polyp measuring 6 mm or three or more polyps of any size. Of these, PillCam COLON identified 14 (70%) and colonoscopy 16 (80%). There were no adverse events reported except in one patient who had severe abdominal pain immediately following colonoscopy. The colonic preparation was well tolerated in all cases.
The initial 44 subjects enrolled in the study received a single oral "booster" dose of sodium phosphate. The PillCam COLON capsule was excreted within 10 hours in 70% of the patients and reached various parts of colon in the other 30%. An additional dose of oral sodium phosphate was added to the regimen of the final 46 subjects to improve the capsule excretion rate. The PillCam COLON capsule in these patients was excreted within 10 hours in 78% of the patients and reached the rectosigmoid colon in the other 22%. Study investigators concluded that further improvements in the procedure will probably increase capsule examination completion and polyp detection rates.
PillCam COLON capsule compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study
Conducted by investigators at Erasme University Hospital in Belgium, this single-center prospective pilot study compared PillCam COLON with colonoscopy for colorectal tumor diagnosis. Of the 41 patients enrolled in the study, 36 were analyzed.
PillCam COLON identified polyps of any size in 19 of 25 patients or 76% and significant polyps, defined as at least one polyp measuring 6 mm or three or more polyps of any size, in 10 out of 13 patients or 77%. Seven polyps not captured during colonoscopy were also identified by PillCam COLON.
The overall sensitivity of PillCam COLON to detect polyps was 77% and specificity was 70%. PillCam COLON was excreted within 10 hours in 84% of the patients and reached various parts of colon in the other 16%. The investigators concluded that PillCam COLON visualized the entire colon in the majority of cases and provides encouraging sensitivity and negative predictive values for the detection of significant lesions.
About PillCam COLON
PillCam COLON is the third video capsule to be developed and manufactured by Given Imaging Ltd. The Company expects to file for clearance of PillCam COLON with the U.S. Food and Drug Administration by the end of 2006. The capsule measures 11 mm by 31 mm -- roughly the size of a large vitamin pill. Since the lumen of the colon is wider than the small bowel and it is highly compartmentalized, the Company has integrated new features into PillCam COLON. The capsule has tiny cameras at each end which capture 4 images a second for up to 10 hours. Each camera contains automatic lighting control and captures more than twice the coverage area and depth of field of the PillCam(TM) SB capsule that is used to diagnose diseases in the small intestine. Multi-center trials are underway in Europe and the U.S.
A patient swallows the PillCam COLON capsule with a glass of water. A prep, as well as additional prokinetic agents to enhance capsule propulsion, are also part of the PillCam COLON capsule procedure. The platform for PillCam COLON includes the same components as PillCam SB and ESO including a sensor array and data recorder. Upon completion of the procedure, the physician downloads the recorded data to a RAPID workstation to review the images.
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(TM) 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 RAPIDŽ 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 50 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 clinical trials are underway in the United States to support submission for marketing clearance from the FDA. A capsule to visualize the stomach is under development. More than 400,000 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) 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 impact of the newly adopted SFAS 123R for expensing option-based payments, (11) the possibility of armed conflict or civil or military unrest in Israel, 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, 2005. 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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