Given Imaging Announces Reimbursement for Capsule Endoscopy in Switzerland
Coverage for capsule endoscopy in Europe continues to grow
Yoqneam, Israel - December 1, 2003 - Given Imaging Ltd. (NASDAQ: GIVN) announced today that the Swiss Federal Department of Home Affairs (EDI) has approved reimbursement of capsule endoscopy for patients with obscure bleeding following negative upper and lower endoscopy procedures. The decision will take effect as of January 1, 2004.
The decision to provide reimbursement for Switzerland's 7.3 million citizens was made following submission of a dossier with data that related to obscure bleeding. Several clinics and hospitals already perform capsule endoscopy in Switzerland. The public healthcare systems of five European countries, including Portugal, Austria, Denmark and Sweden already offer reimbursement for capsule endoscopy bringing the total number of Europeans with access to capsule endoscopy to 36.3 million people.
“We are pleased with the growing momentum that we see in the European market as evidenced by today's news regarding Swiss coverage for capsule endoscopy,” said Gavriel D. Meron, President and CEO of Given Imaging. “As anticipated, we are seeing more and more countries include capsule endoscopy into their reimbursed basket of advanced healthcare solutions.”
About Given Imaging
Given Imaging develops, produces and markets the GivenŽ Diagnostic System featuring the M2AŽ Capsule Endoscope, the only non-invasive method for direct visualization of the entire small intestine. The system uses a disposable miniature video camera contained in a capsule which is ingested by the patient. The M2AŽ capsule passes naturally through the digestive tract, transmitting high quality color images, without interfering with the patient's normal activities. The system received clearance from the FDA in August 2001 and received permission to affix the CE mark in May 2001. Distribution channels for the system have been established in more than 50 countries worldwide. More than 65,000 capsules have been used in clinical practice. Thousands of patients around the world have benefited from the M2AŽ capsule which has been used to diagnose a range of diseases of the small intestine including Crohn's Disease, Celiac disease and other malabsorption disorders, benign and malignant tumors of the small intestine, vascular disorders, medication related small bowel injury, as well as a range of pediatric small bowel disorders. For more information, visit www.givenimaging.com.
This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues, and our future 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 possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission.