Given Imaging Announces Reimbursement in Japan for Expanded PillCam SB(R) Indications
July 11 2012 - 7:00AM
Marketwired
Given Imaging (NASDAQ: GIVN), a world leader in specialty GI
products and pioneer of capsule endoscopy, today announced that
Japan's Ministry of Health, Labor and Welfare (MHLW) has issued
reimbursement codes for the PillCam Patency Capsule for use with
PillCam SB® and for the PillCam SB video capsule for expanded
indications for patients with known or suspected small bowel
disease, including the visualization and diagnosis of Crohn's
disease. PillCam SB may now be used as a first line tool without
the need for upper or lower endoscopy.
Reimbursement for both the PillCam Patency Capsule and for
expanded indications for PillCam SB in Japan is effective for the
entire 105-million adult population as of July 1, 2012. Given
Imaging is the only company offering the PillCam Patency Capsule to
gastroenterologists in Japan.
"Most of our patients prefer PillCam SB as it is less invasive
than other diagnostic methods and allows them to continue their
normal daily activities," said Dr. Akira Terano, M.D., Ph.D.,
Emeritus President, Dokkyo Medical University, Tochigi, Japan and
Chairman, Japan Association for Capsule Endoscopy. "We thank the
Ministry of Health, Labor and Welfare for making it easier for
people suffering from GI disorders of the small bowel to undergo
this valuable procedure so that we can detect and treat their
conditions."
"Reimbursement for expanded PillCam SB indications in Japan
represents one of the broadest PillCam SB coverage policies in the
world," said Homi Shamir, president and CEO, Given Imaging Ltd.
"Our team in Japan will be working diligently to ensure that the
medical community is aware of these new codes, which mean better
access to PillCam SB for patients."
About Given Imaging Ltd. Since pioneering
the field of capsule endoscopy in 2001, Given Imaging has become a
world leader in GI medical devices, offering health care providers
a range of innovative options for visualizing, diagnosing and
monitoring the digestive system. The company offers a broad product
portfolio including PillCam® video capsules for the small bowel,
esophagus and colon [PillCam® COLON not approved for use in the
United States.], industry-leading ManoScan™ high-resolution
manometry and Bravo® pH and Digitrapper® pH and impedance
monitoring. Given Imaging is committed to delivering breakthrough
innovations to the GI community and supporting its ongoing clinical
needs. Given Imaging's headquarters are located in Yoqneam, Israel,
with operating subsidiaries in the United States, Germany, France,
Japan, Australia, Vietnam and Hong Kong. For more information,
please visit www.givenimaging.com.
Forward-Looking Statements 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) our ability to
develop and bring to market new products, (2) our ability to
successfully complete any necessary or required clinical studies
with our products, (3) our ability to receive regulatory clearance
or approval to market our products or changes in regulatory
environment, (4) our success in implementing our sales, marketing
and manufacturing plans, (5) the level of adoption of our products
by medical practitioners, (6) the emergence of other products that
may make our products obsolete, (7) lack of an appropriate bowel
preparation materials to be used with our PillCam COLON capsule,
(8) protection and validity of patents and other intellectual
property rights, (9) the impact of currency exchange rates, (10)
the effect of competition by other companies, (11) the outcome of
significant litigation, (12) our ability to obtain reimbursement
for our product from government and commercial payers, (13)
quarterly variations in operating results, (14) the possibility of
armed conflict or civil or military unrest in Israel, (15) the
impact of global economic conditions, (16) our ability to
successfully integrate acquired businesses, (17) changes and
reforms in applicable healthcare laws and regulations, (18) quality
issues and adverse events related to our products, such as capsule
retention, aspiration and failure to attach or detach, bleeding or
perforation that could require us to recall products and impact our
sales and net income, and (19) 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, 2011. 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. 212 867 1768 flazar@lazarpartners.com
dcarey@lazarpartners.com Israel Investor Contact: Nava Ladin
Gelbart Kahana Investor Relations +972-3-6074717
nava@gk-biz.com
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