U.K. National Health Service Approves PillCam(R) SB
December 16 2004 - 12:01AM
PR Newswire (US)
U.K. National Health Service Approves PillCam(R) SB YOQNEAM,
Israel, Dec. 16 /PRNewswire-FirstCall/ -- Given Imaging (NASDAQ:
GIVN), the global leader in capsule endoscopy, today announced that
the United Kingdom National Health Service (NHS) has issued
guidance on the use of capsule endoscopy for detecting small bowel
disorders. According to the guidance issued by the National
Institute for Clinical Excellence (NICE), all U.K. residents now
have access to capsule endoscopy for obscure GI bleeding, the
investigation and diagnosis of Crohn's disease, and other
indications. "We applaud the U.K. government's decision to enable
its residents to benefit from the newest and most effective
diagnostic tool for detecting disorders of the small bowel," said
Gavriel D. Meron, president and CEO of Given Imaging. "Approval in
the United Kingdom means that 58 million U.K. residents now have
free access to capsule endoscopy under the NHS' public health
system." About Given Imaging Given Imaging is redefining
gastrointestinal diagnosis by developing, producing and marketing
innovative, patient-friendly products for detecting
gastrointestinal disorders. The company is developing a complete
line of PillCam video capsules for detecting disorders throughout
the gastrointestinal tract. The company's technology platform is
the Given(R) Diagnostic System, featuring the PillCam(TM) video
capsule, a disposable, miniature video camera contained in a
capsule, which is ingested by the patient. The PillCam(TM) SB video
capsule is the only naturally ingested method for direct
visualization of the entire small intestine. It is currently
marketed in the United States and in more than 60 other countries
and has benefited more than 145,000 patients worldwide. The
PillCam(TM) ESO video capsule, which provides visual examination of
the esophagus, has been cleared for marketing by the FDA.
Additional capsules for visualization of the stomach and colon are
under development. Given Imaging's headquarters, manufacturing and
R&D facilities are located in Yoqneam, Israel; it has direct
sales and marketing operations in the United States, Germany and
France, and local offices in Tokyo, Madrid and Sydney. For more
information, visit http://www.givenimaging.com/ . This press
release contains forward-looking statements about Given Imaging,
including projections about our business, our future revenues and
our future profitability, within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. For example, statements in the future tense, words
such as "anticipates," "estimates," "expects," "intends," "plans,"
"believes," and words and terms of similar substance used in
connection with any discussion of future operating or financial
performance identify such forward-looking statements. Those
forward- looking statements are not guarantees of future
performance and actual results could differ materially from our
current expectations as a result of numerous factors, including but
not limited to the following: changes in regulatory environment,
our success in implementing our sales, marketing and manufacturing
plan, protection and validity of patents and other intellectual
property rights, the impact of currency exchange rates, the effect
of competition by other companies, the outcome of future
litigation, the reimbursement policies for our product from
healthcare payors, quarterly variations in operating results, the
possibility of armed conflict or civil or military unrest in Israel
and other risks disclosed in our filings with the U.S. Securities
Exchange Commission. DATASOURCE: Given Imaging CONTACT: Yoram
Ashery of Given Imaging Inc.; Fern Lazar, , David Carey, ,
1-866-GIVEN-IR, of Lazar Partners Ltd. for Given Imaging Web site:
http://www.givenimaging.com/
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