Given Imaging Receives Clearance for the Third Generation PillCam(R) SB System
News Continues Given Imaging's Series of Regulatory Successes During 2013
YOQNEAM, Israel, Sept. 23, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd,
(Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer
of capsule endoscopy, today announced that Japan's Pharmaceuticals and Medical
Devices Agency (PMDA) has granted approval for the PillCam SB 3 system. The
innovative technology in this third-generation system will provide physicians
throughout Japan, the world's second largest healthcare market, with the most
advanced PillCam capsule endoscopy technology to detect and monitor small
bowel diseases, such as Crohn's disease.
PillCam SB 3
Videos accompanying this release are available at
A photo accompanying this release is available at
"Approval of the PillCam SB 3 system in Japan underscores our global
commitment to providing physicians with innovative tools to detect and monitor
abnormalities of the gastrointestinal tract," said Homi Shamir, President and
CEO, Given Imaging. "The approval of the PillCam SB 3 system in Japan builds
upon our recent regulatory momentum that includes PillCam COLON in Japan and
PillCam SB 3 in the U.S. Japan is a critically important healthcare market and
we look forward to working with physicians there to integrate PillCam SB 3's
benefits into clinical practice."
Each component of the PillCam SB 3 system, including the capsule, recorder,
sensor belt, and software, has been enhanced to work together to improve image
quality, tissue coverage and efficiency. New adaptive frame rate technology
also allows the capsule to automatically increase the rate at which images are
taken when it senses it is moving more quickly through the digestive tract.
Improvements in the new system's RAPID^® for PillCam software enable even
smarter video compilation which is 40% more efficient than with PillCam SB
2^1. The company expects to begin recognizing sales of PillCam SB 3 in Japan
"With its higher resolution and improvement in capturing images of the small
bowel mucosa, the new PillCam SB 3 capsule endoscopy system provides us with
enhanced performance and efficiency," said Tetsuya Nakamura, M.D.,
Ph.D.,Professor and Director,Department of Medical informatics, Dokkyo
Medical University."With these improvements, along with recently receiving
an expanded indication, PillCam SB will continue to play an important role in
the diagnosis and treatment of small bowel diseases in Japan."
Given Imaging will be participating in the upcoming Japan Digestive Disease
Week (JDDW) conference taking place between October 9th -12th, 2013 in
Tokyo.Company representatives will be available to share information about
the newest features and capabilities of the PillCam SB 3 system along with
Given Imaging's entire portfolio of gastrointestinal screening, diagnostic and
About PillCam^® SB 3
The PillCam SB 3 capsule is a minimally invasive procedure to visualize and
monitor small bowel abnormalities associated with Crohn's disease, iron
deficiency anemia (IDA) and obscure GI bleeding (OGIB). The PillCam measures
11 mm x 26 mm and weighs less than four grams. Now in its third generation,
PillCam SB 3 contains an imaging device and light source and transmits images
at a rate between two and six images per second.Initially cleared by theU.S.
Food and Drug Administrationin 2001, PillCam SB is an accurate,
patient-friendly tool used in patients two years and older by physicians to
visualize the small bowel. PillCam SB 3 builds on Given Imaging's unique
expertise and collaborative efforts as an industry leader that includes more
than 2 million uses of PillCam capsules in patients worldwide and more than
1,900 clinical studies.
The risks of PillCam capsule endoscopy include capsule retention, aspiration
and skin irritation. Endoscopic placement may present additional risks.
Medical, endoscopic, or surgical intervention may be necessary to address any
of these complications, should they occur.
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® capsule endoscope for the small bowel, esophagus and colon. The
company also offers industry-leading GI functional diagnostic solutions
including ManoScan® high resolution manometry, Bravo® capsule-based pH
monitoring, Digitrapper® pH-Z monitoring, and SmartPill® motility monitoring
systems. 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, Hong Kong and
Brazil. For more information, please visit 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. Such forward-looking statements include statements relating to the
Company exploring strategic alternatives and considering possible strategic
transactions involving the Company. 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, (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, 2012. 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 to the extent expressly
required under applicable law, the Company undertakes no obligation to release
publicly any revisions to any forward-looking statements, to report events or
to report the occurrence of unanticipated events.
^1 Given Imaging, comparative study, data on file 2012.
The photo is also available via AP PhotoExpress.
CONTACT: Chantal Beaudry/Martyna Gawrych
Lazar Partners Ltd.
Lazar Partners Ltd.
Israel Investor Contact:
Gelbart Kahana Investor Relations
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