SOURCE: Given Imaging

April 12, 2006 09:38 ET

Given Imaging's PillCam SB Designated as a First Line Diagnostic Tool Under Revised South Carolina Medicare Policy

YOQNEAM, ISRAEL -- (MARKET WIRE) -- April 12, 2006 -- Given Imaging Ltd. (NASDAQ: GIVN) today announced that South Carolina Medicare, administered by Palmetto GBA with approximately 500,000 beneficiaries, updated its guidelines for capsule endoscopy of the small bowel effective April 28, 2006. Under the revised guidelines, small bowel capsule endoscopy may be reimbursed as a first line procedure to evaluate signs or symptoms that are suspected to be indicative of small bowel neoplasms and Crohn's disease. With these updated guidelines, patients will not be required to undergo any other diagnostic test or procedure prior to capsule endoscopy.

Additionally, South Carolina Medicare expanded reimbursement for the evaluation of iron deficiency anemia suspected to be due to gastrointestinal blood loss of obscure origin following an inconclusive upper and lower endoscopy.

"Today's news reflects the impact of recent clinical data showing PillCam's value as a first-line diagnostic tool to detect small bowel disorders. We are also pleased to see that the healthcare payor community is beginning to recognize the role of PillCam ESO for esophageal disease and we expect to announce additional policies throughout the year," said Nachum Shamir, president and CEO of Given Imaging.

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™ 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 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.

Contact Information

  • For further information contact:
    Mark Gilreath
    Given Imaging Ltd.

    Fern Lazar/David Carey
    Lazar Partners Ltd.
    Phone: (866) GIVEN IR
    Email Contact
    Email Contact