Healthcare Industry News: Capsule Endoscopy
News Release - March 12, 2007
Given Imaging Announces 500,000th PillCam(TM) SB Capsule MilestoneYOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Mar 12, 2007 -- Given Imaging (NasdaqGM:GIVN ) announced today the sale of the 500,000th PillCam(TM) SB video capsule. Launched approximately five years ago, Given Imaging is the leader in advancing Capsule Endoscopy, a safe and effective diagnostic tool for detecting disorders of the GI tract. Today, PillCam capsule endoscopes are being used in more than 60 countries around the world.
"Ten years ago, no one believed that it was possible to fit a camera within a capsule so small that it could be swallowed," said Homi Shamir, president and CEO of Given Imaging. "Today, that dream is a reality. When we started this journey, we focused our efforts on the small bowel. Today, we have expanded our product portfolio with additional capsules for the esophagus and colon. This milestone reflects the growth and value of our Company and our innovative technology and shows that patients and physicians prefer safe, patient-friendly GI diagnostic procedures. We would like to thank gastroenterologists from around the world for their support in adopting PillCam Capsule Endoscopy to improve patient care."
"Capsule Endoscopy is one of the most important innovations in the history of endoscopy and holds promise to transform diagnostic and screening endoscopy in the near future," said Christopher J Gostout, M.D., Past President of the American Society of Gastrointestinal Endoscopy. "The ongoing and accumulated clinical experience with Capsule Endoscopy of the small intestine has proven its value as a primary examination of the small intestine."
The PillCam SB video capsule is used to visualize the small bowel. Given Imaging also developed, manufactures and sells the PillCam(TM) ESO, used by physicians to visualize the esophagus and developed PillCam(TM) COLON to visualize the colon. PillCam COLON is cleared for sale in the EU and is pending FDA clearance. Instead of using traditional tube-like endoscopes, Capsule Endoscopy allows the patient to swallow a pill-sized camera that captures images of the GI tract as it travels through the body.
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 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 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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