Latest-Version Reading Software Offers Physicians Improved Workflow and Technological Compatibility; New 12-Hour Small Bowel Capsule and PillCam Delivery Device Provide Targeted Tools for Specialized Patient Populations
SAN ANTONIO, TX, Oct 18, 2010 (MARKETWIRE via COMTEX) --
Given Imaging Ltd. (NASDAQ: GIVN), the world leader in specialty GI
products and pioneer of capsule endoscopy, today unveiled two new
products: PillCam Express, a video capsule delivery device for
patients who are unable to ingest the capsule or who have slow
gastric emptying times, and PillCam SB 2-EX, a small bowel capsule
which extends capsule operating time to a minimum of 12 hours for
patients who are confirmed or believed to have slow motility. The
company also launched an updated version of its proprietary software
program, RAPID(R) 6.3, designed to work with all versions of Windows
7, improve the user experience and reduce potential for data errors.
PillCam Express, PillCam SB 2-EX and RAPID 6.3 can be seen, along
with Given Imaging's entire line of products, at the Company's booth
#715 at the American College of Gastroenterology (ACG) Annual
Scientific Meeting and Postgraduate Course taking place in San
Antonio, Texas, from October 15 through October 20, 2010.
"Given Imaging's commitment to innovation is evidenced by our
continuous introduction of new products and upgrades aimed at meeting
the real-life needs of patients and the health care providers who
care for them," said Homi Shamir, President and CEO, Given Imaging.
"PillCam Express, PillCam SB 2-EX and RAPID 6.3 demonstrate that
commitment to innovation, to patients and to serving the GI
community."
PillCam(R) Express(TM)
The PillCam Express video capsule delivery
device enables capsule placement in patients who are unable to ingest
the capsule or who have slow gastric emptying times and was designed
to work specifically with the PillCam SB 2 family of video capsules.
PillCam Express includes the following features:
-- Clear design enables visualization of capsule deployment through the
endoscope
-- Single-use, quick-locking mechanism that safely secures the capsule
holder to the catheter
-- Proprietary balloon deployment mechanism specifically designed to work
with the current generation of PillCam SB 2 video capsules, ensuring
that the capsule will not be scratched or damaged
-- Smooth catheter design to ensure no damage to the working channel of
the endoscope
PillCam SB 2-EX
PillCam SB 2-EX offers a 12-hour extended procedure
for patients with known or suspected slow motility. Physicians may
consider using PillCam SB 2-EX for hospital inpatients or other
patients who are immobile, taking pain medication or have undergone
recent sedation. PillCam SB 2-EX:
-- Collects data for a minimum of 12 hours and can be used with RAPID
Real-Time handheld viewer to confirm capsule progress.
-- Is FDA-cleared for use in children two years and older.
-- Can be used independently or in conjunction with the PillCam Express
placement device.
Next-Generation Software
The latest version of the RAPID(R) Software
Suite, which includes RAPID v6.3, RAPID(R) Access and RAPID(R)
Reader, incorporates the following new features:
-- Compatibility with Windows 7, Windows Vista, Windows XP in 32- and
64-bit versions, with support for widescreen and different screen
resolutions
-- Spell-check capabilities in eight languages, including English.
-- Smart Check-in with pull-down menu options and built-in safety
measures to prevent incompatible check-in data combinations
-- Enhanced Study Manager, which enables multi-study operations and
allows users to define portions of the data display
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced
gastrointestinal visualization by developing innovative,
patient-friendly tools based on its PillCam(R) Platform. PillCam(R)
capsule endoscopy provides physicians with natural images of the
small intestine via PillCam(R) SB, the esophagus through PillCam(R)
ESO and the colon with PillCam(R) COLON [PillCam COLON is not cleared
for use in the USA]. The PillCam(R) capsules are miniature video
cameras that patients ingest. Given Imaging's other capsule products
include Agile(TM) patency capsule, to verify intestinal patency, and
Bravo(R), the only wireless, catheter-free, 48-hour pH test
commercially available for pH testing to assess gastroesophageal
reflux disease (GERD). Given Imaging's products use cutting-edge,
wireless technology and advanced software to enable
gastroenterologists to visualize diseases of the esophagus, small
bowel and colon. All Given Imaging products allow patients to
maintain normal activities. In April 2010 Given Imaging acquired
Sierra Scientific Instruments, a leading provider of specialty GI
diagnostic solutions and pioneer of high-resolution manometry for
assessing gastrointestinal motility. Sierra Scientific is now a
wholly-owned subsidiary of Given Imaging. Given Imaging's
headquarters, manufacturing and R&D facilities are located in
Yoqneam, Israel, with operating subsidiaries in the United States,
Germany, France, Japan, Australia, Singapore 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 payors,
(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 and (18) 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, 2009. 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.
1-(866) GIVEN-IR
Email Contact/
Email Contact
SOURCE: Given Imaging
http://www2.marketwire.com/mw/emailprcntct?id=7675646CF6B0A77D
http://www2.marketwire.com/mw/emailprcntct?id=0A390EF7FAB8FC8F