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FWD: Given Imaging Receives Permanent Medicare Funding for PillCam(R   Message List  
Reply | Forward Message #50 of 57 |
<http://money.cnn.com/news/newsfeeds/articles/marketwire/0397376.htm>

Given Imaging Receives Permanent Medicare Funding for PillCam(R) SB in
Australia

Funding Application Supported by Largest Body of Clinical Data on PillCam
Capsule Endoscopy
May 15, 2008: 12:00 AM EST

Given Imaging Ltd. (NASDAQ: GIVN) today announced that the Australian
Government Department of Health and Ageing has approved permanent Medicare
funding for capsule endoscopy of the small bowel. Capsule endoscopy has
been interim Medicare funded in Australia subject to data collection since
May 2004. Medicare is the scheme that gives all Australian residents
access to subsidized health care.

The Australian PillCam database was developed and supported by members of
the Gastroenterological Society of Australia (GESA) in collaboration with
Given Imaging and resulted in a database of 2,949 patients. This data set
is the largest body of data ever accumulated on PillCam SB® and the
largest data set ever submitted to the Medical Services Advisory Committee
(MSAC). MSAC is the committee that advises the Australian Federal Minister
for Health and Ageing on the safety, efficacy and cost-effectiveness of
new medical procedures and technologies.

"We are pleased to receive permanent Medicare funding for PillCam SB in
Australia, which is an important milestone for Given Imaging," said Homi
Shamir, president and CEO of Given Imaging. "Importantly, it reflects the
successful collaboration between our company, the GI community and the
Australian Government to ensure that such decisions are based on clinical
evidence that demonstrated PillCam's safety, efficacy and
cost-effectiveness. We thank the Australian Gastroenterological Society
for their leadership in this process and look forward to working with them
in order to obtain reimbursement for additional indications for PillCam SB
in the future."

Some of the key findings from the database include:

1. A finding of GI abnormalities in 71.1% of patients (compared to the
59.9% assumed in MSAC Assessment Report #1057, based on clinical trial
data);
2. An estimated average cost reduction of AUD 2,667 per patient in other
investigational procedures including colonoscopy, enteroscopy and
small bowel follow through in the 12 months following PillCam capsule
endoscopy;
3. Cost savings, based on a reduction in hospitalisation rates from 44.6%
in the year prior to PillCam capsule endoscopy to 11.6% in the year
post PillCam capsule endoscopy.


The company intends to work with the GI community to continue to analyze
the database and submit studies for presentation at future medical society
conferences.

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(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
Email Contact
David Carey
Email Contact
Lazar Partners Ltd.
212 867 1768



Fri May 16, 2008 5:24 am

daleroose
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<http://money.cnn.com/news/newsfeeds/articles/marketwire/0397376.htm> Given Imaging Receives Permanent Medicare Funding for PillCam(R) SB in Australia Funding...
Dale Roose
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May 16, 2008
5:24 am
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