Healthcare Industry News: Capsule Endoscopy
News Release - August 10, 2006
Given Imaging Announces French Health System Completes First Step in Covering PillCam(TM) SBYOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Aug 10, 2006 -- Given Imaging Ltd. (NASDAQ:GIVN ) today announced that the French National Authority for Health (HAS) has completed the first step in advancing universal reimbursement for PillCam SB Capsule Endoscopy for over 60 million French citizens. In late July, the HAS published a report that highly recommends the use of PillCam SB in patients with obscure gastro-intestinal bleeding and Crohn's disease following inconclusive first-line tests.
The HAS advises the French government on decisions related to the reimbursement of medical products and services. Its report, "Examination of the Lumen of the Digestive Tract by Ingested Video Capsule," was based on an extensive analysis of existing clinical data and opinions from leading French physicians. The report concludes that Capsule Endoscopy provides additional medical benefit and, as a result, recommends including Capsule Endoscopy in the list of reimbursable procedures, using the previously assigned code HZQE900 and CCAM classification 07.010.9.01 (CCAM = Classification Commune des Actes Médicaux). Receiving the code and recommendation for reimbursement from the HAS is regarded as the pivotal step toward achieving universal reimbursement for PillCam SB in France. The next step will be for UNCAM (Union Nationale des Caisses Assurances Maladies) to set a monetary value for the code which is expected to occur during 2007.
"We are extremely pleased with the HAS recommendation and believe that it sets the stage for universal access to PIllCam SB in France by 2007," said Homi Shamir, president and CEO of Given Imaging. "We expect other national health systems to follow France's lead and allow physicians to use PillCam Capsule Endoscopy to detect and monitor patients with small bowel illnesses."
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 Given® 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 380,000 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
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.