Data From Initial PillCam COLON 2 Trial Shows Better Performance Compared to First-Generation PillCam COLON; Study to Be Published in December 2009 Endoscopy JournalYOQNEAM, ISRAEL, Nov 23, 2009 (MARKETWIRE via COMTEX) -- Given Imaging Ltd. (NASDAQ: GIVN), the global leader in capsule
endoscopy, today announced the launch of its second-generation
PillCam(R) COLON capsule at the Gastro 2009 Conference taking place
in London. Like Given Imaging's other capsule endoscopes, PillCam(R)
SB and PillCam(R) ESO, PillCam COLON could be a more patient-friendly
tool for imaging the gastrointestinal tract.
This advanced PillCam system contains proprietary, innovative
technologies, including intelligent functionality and superior
imaging, designed to provide physicians with clear and precise views
of the colon and polyps of interest. Following receipt of the CE
mark in September 2009, Given Imaging will start marketing PillCam(R)
COLON 2 in select European countries with availability throughout
Europe expected by mid-2010.
The Company also announced that independent investigators presented
results of a 98-patient feasibility study. The investigators concluded
that PillCam COLON 2 is a safe and effective method to visualize the
colon and detect colonic polyps. An article discussing the study has
been accepted for the December 2009 edition of the journal Endoscopy.
High Sensitivity and Specificity
Results of the study comparing PillCam COLON 2 to colonoscopy, showed
a sensitivity of 89 percent and a specificity of 76 percent in
detecting polyps greater than or equal to 6 mm and a sensitivity of 88
percent and a specificity of 89 percent in detecting polyps greater
than or equal to 10 mm. Conducted by clinicians at five hospitals in
Israel, the study evaluated the performance of PillCam COLON 2 in 98
patients who had risks or warning symptoms of colon pathology. Like
Given Imaging's other PillCam capsules, PillCam COLON 2 does not
require the use of sedation, intubation or air insufflation during
the procedure, offering physicians and patients a convenient way to
visualize the colon.
"The data for PillCam COLON 2 are promising and suggest it may be a
safe, minimally invasive option for visualizing the colon in patients
who are unwilling to undergo colonoscopy, have undergone an
incomplete examination, or those for whom colonoscopy is
contraindicated. We are encouraged by the data, which suggest that
PillCam COLON 2 could be a reliable alternative to conventional
colonoscopy for these types of patients," said Prof. Rami Eliakim,
Chairman of Medicine and Director of the Department of
Gastroenterology, Rambam Health Care Campus, Haifa, Israel.
New Features of PillCam COLON 2
Breakthrough technology offered in PillCam COLON 2 and the PillCam
Platform enables a more patient-friendly option for visualizing the
colon. New features include:
Bi-directional communication between PillCam Colon 2 and the
DataRecorder enables tracking of the capsule's motion in the GI tract
so that the image capture rate can be adjusted to maximize colon
-- 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 degrees field of view from each imager offers a near 360 degrees view of the
Additionally, Given Imaging has incorporated other features into the
RAPID(R) 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(R)
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
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
-- 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(R)
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(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 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.
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.
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For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
SOURCE: Given Imaging