Healthcare Industry News: Capsule Endoscopy
News Release - April 24, 2007
Given Imaging Receives Clearance to Sell and Market PillCam(TM) SB in JapanCompany to Host Conference Call Today at 12 pm ET
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Apr 24, 2007 -- Given Imaging Ltd. (NasdaqGM:GIVN ), the global leader in Capsule Endoscopy, today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted a regulatory approval number for the company's PillCam(TM) SB capsule endoscope. With this decision, Given Imaging will begin selling and marketing PillCam SB in Japan.
"This is a major milestone for our company as it means that we will now be able to sell our flagship PillCam SB in the second largest healthcare market in the world," said Homi Shamir, president and CEO of Given Imaging. "Working closely with our partners, we plan to increase awareness of PillCam SB among Japanese gastroenterologists and build a strong installed base of Given workstations. Concurrently, we will work towards obtaining national reimbursement for Capsule Endoscopy. We expect this process to take between nine to twelve months."
"Over the past thirty years we made significant progress in the detection and treatment of gastrointestinal disorders as a result of the endoscope. However the endoscope's inability to visualize the entire length of the small intestine has continued to pose challenges for physicians in detecting diseases that directly impact the small intestine. The approval of Capsule Endoscopy is a win-win for both physicians and patients as we will now be able to fully visualize and better detect small bowel disorders," said Professor Terano, President of Dokkyo Medical University.
In 2002, Given Imaging established a Japanese subsidiary with its partners, Suzuken Co. Ltd., Japan's largest medical device and pharmaceutical distributor, and Marubeni Corporation, one of Japan's largest trading companies. Suzuken will serve as the exclusive distributor of PillCam SB in Japan. Given Imaging maintains a 51% controlling interest in the unit, responsible for commercializing the PillCam line of products in Japan.
The company will host a conference call today at 12:00 pm ET, 7:00 pm Israel time, to discuss Japan approval. To participate in the teleconference, please dial (866) 288-0542 fifteen minutes before the conference begins. International callers should dial (913) 312-6669. The call will also be webcast live at www.givenimaging.com. A replay of the call will be available for thirty days on the company's website, or until May 8, 2007 by dialing (888) 203-1112. International callers should dial (719) 457-0820. The replay participant code is 8574882.
The company will also host a conference call in Hebrew on Wednesday, April 25 at 2:30pm Israel time. For additional information, please contact Shirlee Lev of Given Imaging at +972 4 909 7791.
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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