Given Imaging Announces PillCam(R) Capsule Endoscopy of the Small Bowel Recognized as Primary Evaluation Tool by Largest Payer in Ohio
New Coverage for PillCam(R) Capsule Endoscopy of the Esophagus and Agile(TM) Patency Capsule
YOQNEAM, ISRAEL--(Marketwire - July 14, 2008) - 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® 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® 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™ 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.
Contact Information: For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-(866) GIVEN-IR