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Public Companies : Healthcare/BioTech


Given Imaging Announces PillCam(R) Capsule Endoscopy of the Small Bowel Recognized as Primary Evaluation Tool by Largest Payer in Ohio

Jul 13, 2008 - 11:36:01 PM

News Source MARKET WIRE

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YOQNEAM, ISRAEL -- (MARKET WIRE) -- 07/14/08 -- Given Imaging Ltd. (NASDAQ: GIVN) (TELAVIV: GIVN), the global leader in capsule endoscopy, today announced that MedicalMutual of Ohio, the state's oldest and largest health insurance companyserving more than 3.9 million individuals in Ohio and South Carolina, hasupdated its capsule endoscopy policy effective May 9, 2008. Under the newguidelines, Medical Mutual will allow physicians to use PillCam SB as aprimary test (standard endoscopic procedures and or SBFT are not required)for symptoms indicative of small bowel tumors or Crohn's disease. Anotherchange is that Medical Mutual will now allow the use of PillCam ESO in theevaluation of esophageal varices in patients who have esophageal varices orportal hypertension and when esophagogastroduodenoscopy (EGD) iscontraindicated. The company also announced Medical Mutual's further policyexpansions to include the use of the Agile patency capsule used to verifyadequate patency of the gastrointestinal tract in patients with known orsuspected strictures prior to the administration of the PillCam videocapsule.

Prior to this update, PillCam capsule endoscopy of the small bowel underthe Medical Mutual of Ohio policy could be used only after a negative upperand/or lower endoscopy to diagnose disorders such as Crohn's disease,celiac disease, benign and cancerous tumors, ulcerative colitis as well asother disorders.

"We are pleased that Medical Mutual of Ohio has recognized the value ofPillCam capsule endoscopy to both patients and physicians," said HomiShamir, president and CEO of Given Imaging. "Today, more than 210 millionAmericans have reimbursed access to PillCam SB including 34 millionAmericans 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 athttp://www.medmutual.com or can contact Given Imaging's Reimbursement HelpLine 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 detectinggastrointestinal disorders. The company's technology platform is thePillCam® Platform, featuring the PillCam video capsule, a disposable,miniature video camera contained in a capsule, which is ingested by thepatient, a sensor array, data recorder and RAPID® software. Given Imaginghas a number of available capsules: the PillCam SB video capsule tovisualize the entire small intestine which is currently marketed in theUnited States and in more than 60 other countries; the PillCam ESO videocapsule to visualize the esophagus; the Agile(TM) patency capsule todetermine the free passage of the PillCam capsule in the GI tract and thePillCam COLON video capsule to visualize the colon that has been clearedfor marketing in the European Union. PillCam COLON has received a CE Mark,but is not cleared for marketing or available for commercial distributionin the USA. More than 700,000 patients worldwide have benefited from thePillCam capsule endoscopy procedure. Given Imaging's headquarters,manufacturing and R&D facilities are located in Yoqneam, Israel. It hasoperating subsidiary companies in the United States, Germany, France,Japan, Australia and Singapore. Given Imaging's largest shareholdersinclude Elron Electronic Industries (NASDAQ & TASE: ELRN). For moreinformation, visit http://www.givenimaging.com.

This press release contains forward-looking statements within the meaningof the "safe harbor" provisions of the U.S. Private Securities LitigationReform Act of 1995. These forward-looking statements include, but are notlimited to, projections about our business and our future revenues,expenses and profitability. Forward-looking statements may be, but are notnecessarily, 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-lookingstatements involve known and unknown risks, uncertainties and other factorswhich may cause the actual events, results, performance, circumstances orachievements of the Company to be materially different from any futureevents, results, performance, circumstances or achievements expressed orimplied by such forward-looking statements. Factors that could cause actualevents, results, performance, circumstances or achievements to differ fromsuch forward-looking statements include, but are not limited to, thefollowing: (1) satisfactory results of clinical trials with PillCam COLON(2) our ability to receive regulatory clearance or approval to market ourproducts or changes in regulatory environment, (3) our success inimplementing our sales, marketing and manufacturing plans, (4) protectionand validity of patents and other intellectual property rights, (5) theimpact of currency exchange rates, (6) the effect of competition by othercompanies, (7) the outcome of future litigation, including patentlitigation with Olympus Corporation, (8) our ability to obtainreimbursement for our product from government and commercial payors, (9)quarterly variations in operating results, (10) the possibility of armedconflict or civil or military unrest in Israel, and (11) other risks andfactors disclosed in our filings with the U.S. Securities and ExchangeCommission, including, but not limited to, risks and factors identifiedunder such headings as "Risk Factors," "Cautionary Language RegardingForward-Looking Statements" and "Operating Results and Financial Review andProspects" in the Company's Annual Report on Form 20-F for the year endedDecember 31, 2007. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date of this pressrelease. Except for the Company's ongoing obligations to disclose materialinformation under the applicable securities laws, it undertakes noobligation to release publicly any revisions to any forward-lookingstatements, to report events or to report the occurrence of unanticipatedevents.

For further information contact:

Fern Lazar/David Carey
Lazar Partners Ltd.
1-(866) GIVEN-IR
Email Contact
Email Contact



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