Healthcare Industry News: Given Imaging
News Release - October 20, 2006
Given Imaging's PillCam(TM) COLON Receives CE Mark in European UnionNew Video Capsule to Visualize the Colon to Be Unveiled at United European Gastroenterology Week
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Oct 20, 2006 -- Given Imaging Ltd. (NASDAQ:GIVN ) today announced that it received the CE Mark to market PillCam(TM) COLON throughout the European Union. PillCam COLON was developed as a diagnostic test to visualize the colon. To be unveiled to physicians at the United European Gastroenterology Week (UEGW) in Berlin, Germany from October 21-25, PillCam COLON can be used with The PillCam® Platform. The Company will release the PillCam COLON to the market gradually following the completion of additional clinical trials.
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.
"Today begins a new chapter for our Company and confirms our leadership in the field of capsule endoscopy. Our ultimate goal is to deliver innovative, patient-friendly products that improve how G.I. disorders are diagnosed and treated," said Homi Shamir, president and CEO of Given Imaging. "To this end, the initial PillCam COLON data is encouraging and we believe it will be an effective tool for physicians to visualize the colon."
Data from the first European clinical trial for PillCam COLON will be presented at UEGW. A single-center prospective pilot study conducted by investigators at Erasme University Hospital in Belgium compared PillCam COLON with colonoscopy. Thirty-six (n=36) of the 41 patients enrolled in the study 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 more than three 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%. 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.
How PillCam COLON Works
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 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 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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