Healthcare Industry News: Capsule Endoscopy
News Release - October 23, 2006
Given Imaging Announces Data Presented at American College of Gastroenterology Annual MeetingFirst U.S. PillCam(TM) COLON Study Results Revealed
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Oct 23, 2006 -- Given Imaging Ltd. (NASDAQ:GIVN ) today announced highlights of clinical data presented on PillCam(TM) Capsule Endoscopy at the Annual Scientific Meeting of the American College of Gastroenterology which takes place in Las Vegas, Nevada from October 20 to 25. Noteworthy presentations include data from the first U.S. trial studying PillCam(TM) COLON as well as a study validating a new index to measure small bowel mucosal activity.
"Capsule Colonoscopy - An Interim Report of a Pilot Three Arm, Blinded Trial of Capsule Colonoscopy, Virtual Colonoscopy and Colonoscopy" - (Poster #784) Press Conference - Monday, October 23rd, 2006 at 12:30pm PDT
Led by Blair Lewis, M.D., Mount Sinai Medical Center, Douglas Rex, M.D., Indiana University Hospital, and David Lieberman, M.D., Oregon Health and Science University, the study evaluated 25 patients over the age of 50 who had not had a colonoscopy within the past five years or a family history of colon cancer. The patients underwent PillCam COLON followed by virtual colonoscopy and standard colonoscopy three weeks later. Investigators were blinded to the results. Of the 25 patients, 44% (n=11) had significant findings defined as at least one polyp measuring 6 mm or more than three polyps of any size, confirmed by standard colonoscopy (blinded or unblinded). PillCam COLON identified 64% or (n=7) of the significant polyps, virtual colonoscopy identified 55% (n=6) and blinded standard colonoscopy 82% (n=9). The investigators concluded that PillCam COLON is a promising new technology for visualizing the colon for polyps.
"PillCam COLON in Comparison with Standard Colonoscopy in the Detection of Polyps-Results from the First Prospective Multi-Center Study" - (Presentation #52) Press Conference - Monday, October 23rd, 2006 at 12:30pm PDT; Podium Presentation - Wednesday, October 25th at 8:30am PDT
A total of 91 individuals were enrolled in three Israeli centers, Rambam Medical Center, Hillel-Yaffe Medical Center and Bikur Holim Hospital; the results were evaluable in 84 cases. The patients all underwent capsule colonoscopy with the PillCam COLON and 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 traditional 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.
Capsule Endoscopy in Patients with Known IBD: Frequency of Findings, and Influence on Medical and Surgical Management are based on the indication for CE" (Poster #1085) - Tuesday, October 24th 12:15pm - 2:15pm PDT
Researchers at Mount Sinai Medical Center led by Stephanie Santos, M.D., conducted a study to determine how often PillCam SB identifies significant findings in inflammatory bowel disease (IBD) patients and whether those findings impacted the management of these patients. Sixty-nine (69) patients were grouped into one of three categories based on their indication for Capsule Endoscopy: Indeterminate colitis to rule out small bowel disease (IC), known Crohn's disease with unexplained symptoms (CD-Sx) or known Crohn's disease with obscure bleeding (CD-OB). The investigators concluded that PillCam SB findings and the associated changes in management were significantly more common in patients with known Crohn's disease with unexplained symptoms, or obscure bleeding, than in patients with indeterminate colitis. Overall PillCam SB led to a change in management in the majority of patients 59% (n=41), supporting its use in patients with IBD.
"Development and Validation of a Capsule Endoscopy Scoring Index for Small Bowel Mucosal Disease Activity: The Lewis Score" (Poster #689) - Monday, October 23rd 12:15pm - 2:15pm PDT
A team of seven investigators sought to develop and validate a simple, user-friendly PillCam Capsule Endoscopy scoring index to measure small bowel mucosal disease activity. Over a two year period, seven endoscopic variables were developed and evaluated including erythema; edema; nodularity, villous appearance; denuded mucosa, ulceration and stenosis. Additional index parameters measured include the number of lesions, the longitudinal extent of the disease, and ulcer shape and size. Based on a prospective review of forty (40) full length PillCam SB videos and ten (10) thumbnailed studies, the investigators concluded that the scoring index should include three variables; villous edema, ulceration and stenosis. The study also concluded that The Lewis Capsule Endoscopy scoring index may prove useful in measuring small bowel mucosal disease activity and serve as an objective scoring metric to measure small bowel disease states.
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 PiIlCam 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. Pivotal multi-center trials are underway in Europe and the U.S.
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 multi-center clinical trials are underway in Europe and the U.S. 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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