Healthcare Industry News: Capsule Endoscopy
News Release - April 26, 2006
American Society for Gastrointestinal Endoscopy Updates Technology Review on Capsule EndoscopyDesignates PillCam(TM) SB as First Line Diagnostic Tool
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Apr 26, 2006 -- Given Imaging Ltd. (NasdaqNM:GIVN ) today announced that the American Society for Gastrointestinal Endoscopy (ASGE) has published an updated technology review on Capsule Endoscopy in the April issue of Gastrointestinal Endoscopy. The ASGE conducts Technology Reviews on endoscopic technologies to reflect the most recent clinical data and provides recommendations on the appropriate use of these technologies to physicians. The first Capsule Endoscopy review was published in 2002.
The updated technology review evaluated published clinical data on Capsule Endoscopy through November 2005. Highlights include:
-- PillCam SB: This review cites a number of expanded indications for the procedure based on recently published consensus statements that define guidelines and algorithms for both PillCam SB and PillCam ESO in several disease states. In addition to obscure GI bleeding, the review acknowledged iron deficiency anemia, suspected Crohn's disease, small bowel tumors, and celiac disease as indications for the procedure. The review concluded that PillCam SB has quickly become the first-line tool for imaging small bowel mucosa.
-- PillCam ESO: Barrett's esophagus, esophagitis, and esophageal varices were all cited as common indications for this procedure that images the esophagus. The review concluded that preliminary data for the device showed an excellent diagnostic yield.
Mark Gilreath, SVP, Global Marketing at Given Imaging said, "We are pleased that the ASGE has updated its Technology Review on Capsule Endoscopy and believe this will influence payers to cover the procedure as a first line tool. The updated report reflects advances made to the GivenŽ Diagnostic System since we first introduced the PillCam capsule in 2001, as well as the clinical evidence demonstrated in more than 400 peer-reviewed publications."
The American Society for Gastrointestinal Endoscopy (ASGE), founded in 1941, with more than 9,000 physician members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to Endoscopy, and is the foremost resource for endoscopic education. To view a copy of the report visit www.giejournal.org.
About Given Imaging
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the GivenŽ Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam SB capsule is a naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 300,000 patients worldwide. The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. 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 about Given Imaging, including projections about our business and our future revenues, expenses and profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission.
Source: Given Imaging
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