July 14, 2008
Given Imaging Announces PillCam(R) Capsule Endoscopy of the Small Bowel Recognized As Primary Evaluation Tool By Largest Payer in Ohio
Given Imaging Ltd. (NASDAQ: GIVN) (TELAVIV: GIVN), the global leader in capsule endoscopy, today announced that Medical Mutual of Ohio, the state's oldest and largest health insurance company serving more than 3.9 million individuals in Ohio and South Carolina, has updated its capsule endoscopy policy effective May 9, 2008. Under the new guidelines, Medical Mutual will allow physicians to use PillCam SB as a primary test (standard endoscopic procedures and or SBFT are not required) for symptoms indicative of small bowel tumors or Crohn's disease. Another change is that Medical Mutual will now allow the use of PillCam ESO in the evaluation of esophageal varices in patients who have esophageal varices or portal hypertension and when esophagogastroduodenoscopy (EGD) is contraindicated. The company also announced Medical Mutual's further policy expansions to include the use of the Agile patency capsule used to verify adequate patency of the gastrointestinal tract in patients with known or suspected strictures prior to the administration of the PillCam video capsule.
Prior to this update, PillCam capsule endoscopy of the small bowel under the Medical Mutual of Ohio policy could be used only after a negative upper and/or lower endoscopy to diagnose disorders such as Crohn's disease, celiac disease, benign and cancerous tumors, ulcerative colitis as well as other disorders.
"We are pleased that Medical Mutual of Ohio has recognized the value of PillCam capsule endoscopy to both patients and physicians," said Homi Shamir, president and CEO of Given Imaging. "Today, more than 210 million Americans have reimbursed access to PillCam SB including 34 million Americans with access as a primary diagnostic tool. In addition, approximately 35 million Americans have reimbursed access to PillCam ESO. We anticipate additional coverage decisions like this in the future."
Physicians seeking additional information can access the updated policy at http://www.medmutual.com or can contact Given Imaging's Reimbursement Help Line at 1-888-389-5200.
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(R) 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 RAPID(R) software. Given Imaging has a number of 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; the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 700,000 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 operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). 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) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) 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, 2007. 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.
For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR Email ContactEmail Contact
SOURCE: Given Imaging