-- Adaptive Frame Rate adjusts the image capture rate from four
frames per second to 35 frames per second, enabling creation of a
smooth, continuous video.
-- Polyp Size Estimation is a new research tool that allows
clinicians to estimate the size of polyps.
Superior Imaging Compared to COLON 1
-- Advanced optics for enhanced image quality and polyp detection.
-- 172° field of view from each imager offers a near 360° view of the
colon.
Additionally, Given Imaging has incorporated other features into the
RAPID® software to further streamline office workflow.
"PillCam COLON 2 incorporates the cumulative expertise gained from the
first PillCam COLON as well as more than 1,000,000 PillCam® capsule
ingestions worldwide," said Homi Shamir, president and CEO of Given
Imaging. "Despite the small size of this initial study and the relatively
low prevalence of polyps, we are very encouraged by this data and look
forward to working with leading gastroenterologists in Europe, the United
States and other markets to initiate additional clinical trials."
PillCam COLON 2 will be supported by the PillCam Platform with RAPID C2,
based upon RAPID 6 software.
Conference Call and Webcast Details
Given Imaging will host a conference call and meeting today with members of
the financial community to discuss new features of the company's
second-generation PillCam COLON and review results from the recently
completed Israeli feasibility study. The meeting will take place at the
Novotel London ExCel Hotel, Western Gateway, Royal Victoria Dock, E16 1AA,
London, UK and will begin at 9:00 am New York Time, 2:00 pm London Time.
The meeting will take place in the King George V Room.
To participate in the teleconference, please dial one of the following
numbers ten minutes before the conference is scheduled to begin:
-- U.S. participants: 1-888-219-1217
-- U.K. participants: 08081017548
-- All other international callers please dial +913-312-1463 and include
appropriate codes for dialing the U.S.
This meeting will also be webcast live at www.givenimaging.com. A replay
of the call will be available for two weeks on the company's website, or
until December 7, 2009, by dialing 888-203-1112. Callers outside of the
U.S. should dial 719-457-0820. The replay participant code is 8784603.
About Colon Cancer
Colorectal cancer remains a lethal disease that can be prevented through
early detection. Colon cancer occurs in the large intestine (colon), the
lower part of the digestive system while rectal cancer occurs in the last
15-20 centimeters of the colon. Together, they're often referred to as
colorectal cancers.
Colon and rectal cancers begin in the digestive system and develop when
cells that line the colon or the rectum become abnormal and grow out of
control. Most cases of colon cancer begin as small, non-cancerous (benign)
clumps of cells called adenomatous polyps. Only certain kinds of polyps
have the potential to become cancerous, and in most people, colorectal
cancers develop slowly over a period of several years. More than 50,000
people in the U.S., 40,000 in Japan and 200,000 in Europe die each year
from colorectal cancer.
About PillCam COLON 2
PillCam COLON 2 is equipped with two miniature color video cameras (one on
each end), a battery and an LED light source; it measures 11 mm X 31 mm.
Employing intelligent functionality, PillCam COLON 2 transmits up to 35
frames per second for approximately 10 hours to a recording device worn by
the patient. Data are transferred from the device to a computer that uses
RAPID software to compile the video data and enable the physician to review
and report the results of the PillCam study. PillCam COLON 2 received a CE
Mark in 2009 and will be commercially available in Europe in January 2010.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal diagnosis by
developing innovative, patient-friendly tools based on its PillCam®
Platform. PillCam capsule endoscopy provides physicians with natural images
of the small intestine via PillCam SB, the esophagus through PillCam ESO
and the colon with PillCam COLON [PillCam COLON is not cleared for use in
the USA]. The PillCam capsules are miniature video cameras that patients
ingest. Given Imaging's other capsule products include Agile™ patency
capsule, to verify intestinal patency, and Bravo®, 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 better diagnose diseases of the esophagus, small
bowel and colon and more accurately treat patients. All Given Imaging
products allow patients to maintain normal activities. 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 and Singapore. 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,
and (16) 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, 2008. 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.
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 646-239-6231
