Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced the
publication of data from the largest multi-center study of PillCam®
COLON 2 conducted to date in the September print edition of
Gastrointestinal Endoscopy, the journal of the American Society for
Gastrointestinal Endoscopy. The results confirm that the
second-generation PillCam COLON capsule demonstrated a high
sensitivity for the detection of clinically relevant polypoid
lesions and, thus, could be an appropriate tool for visualizing the
colon.
"Colon capsule endoscopy is a patient-friendly, minimally
invasive technology that enables visualization of the colon without
sedation or air insufflation," said Cristiano Spada*, MD, Catholic
University, Rome, Italy. "The high sensitivity for clinically
relevant lesions shown in this study demonstrates the value of this
tool to complement colonoscopy, which may ultimately result in
improved patient compliance with colorectal screening
guidelines."
The prospective, blinded study conducted at eight European sites
compared colon capsule endoscopy with conventional colonoscopy for
the detection of colorectal polyps or masses greater than or equal
to 6 mm or 10 mm in size in a cohort of patients at average or
increased risk of colorectal neoplasia. Colonoscopy was
independently performed within 10 hours after capsule ingestion or
the next day. Colon capsule endoscopy sensitivity and specificity
for detecting patients with polyps greater than or equal to 6 mm
and greater than or equal to 10 mm in size were assessed. Data from
109 out of 117 patients with a mean age of 60 years were analyzed.
Per-patient colon capsule endoscopy sensitivity for polyps 6 mm and
over and those 10 mm and over was 84% and 88%, with specificities
of 64% and 95%, respectively. Capsule-positive but
colonoscopy-negative cases were counted as "false-positive",
resulting in a lower rate of specificity. In addition, colon
capsule endoscopy detected all three invasive carcinomas.
"We are very encouraged by the positive study results that
underscore the high diagnostic sensitivity PillCam COLON 2
demonstrates in detecting polyps of clinically meaningful size. We
believe that this product will ultimately benefit the significant
number of individuals who should be getting screened for colon
cancer but who are unwilling or unable to undergo routine
colonoscopy," said Homi Shamir, president and CEO of Given Imaging
Ltd. "We are excited by the momentum of our ongoing multi-center
PillCam COLON 2 pivotal study, which is currently underway in the
United States and Israel. We look forward to generating additional
clinical evidence to support the role of PillCam COLON 2 in
potentially improving colon cancer detection rates."
In June, Given Imaging announced the initiation of a
multi-center, pivotal study for PillCam COLON 2, which will support
the company's planned 510(k) submission to the U.S. Food and Drug
Administration (FDA). Seventeen sites will enroll approximately 800
patients, aged 50-75 years, who are at average risk for colonic
polyps and comprise the normal screening population.
*Dr. Cristiano Spada is a paid consultant of Given Imaging.
About Colorectal Polyps There are two
common types of colorectal polyps: adenomatous, which can develop
into cancer, and hyperplastic, which are rarely more than 5 mm in
size and are infrequently cancerous(1). For adenomas, the potential
for malignancy is related to polyp size(2). Larger polyps are more
likely to develop into cancer, and polyps that are over 2 cm in
size may potentially contain cancer(3).
About Colon Cancer Colon cancer involves
the large intestine (colon), the lower part of the digestive tract,
while rectal cancer specifically involves the last 6 inches of the
colon. Together, they're often referred to as colorectal cancers.
Colon and rectal cancers begin in the digestive tract and occur
when cells that line the colon or the rectum become abnormal and
grow uncontrollably. Despite widespread public education efforts,
colorectal cancer screening compliance rates remain low, with just
50% of the eligible US population undergoing a colonoscopy(4).
About 147,000 people in the U.S. are diagnosed with colorectal
cancer annually, according to the National Cancer Institute(5).
Worldwide, the disease causes 1 million cases and 600,000 deaths
every year, with lower CRC screening compliance in Europe and
Japan.
About Gastrointestinal
Endoscopy Gastrointestinal Endoscopy publishes original,
peer-reviewed articles on endoscopic procedures used in the study,
diagnosis, and treatment of digestive diseases. Articles report on
outcomes research, prospective studies, and controlled trials of
new endoscopic instruments and treatment methods. Gastrointestinal
Endoscopy has become the international forum for the newest
developments in the specialty, bringing readers challenging reports
from leading authorities throughout the world. The journal
regularly publishes abstracts of important articles from other
leading clinical publications, complete with commentaries from a
panel of experts.
About PillCam COLON 2 The PillCam® COLON 2
video capsule 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. PillCam COLON 2 is designed to be ingested by the
patient and transmit 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.
All medical procedures carry some risk. The risks of PillCam®
capsule endoscopy include capsule retention, aspiration, or skin
irritation. PillCam COLON capsule endoscopy presents additional
risks, including risks associated with the drug products used to
prepare the patient for the procedure, which are currently used for
colonoscopy, and to move the capsule through the patient's
digestive tract faster. It may also present other risks that are
unknown, but which the clinical studies are designed to detect.
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® video capsules for the small bowel,
esophagus and colon [PillCam® COLON not approved for use in the
United States.], industry-leading ManoScan™ high-resolution
manometry and Bravo® wireless and Digitrapper® pH and impedance
products. 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 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, (18) adverse
events or product quality issues that could require us to recall
products and impact our sales, 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, 2010. 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.
(1)
http://www.mayoclinic.com/health/colon-polyps/DS00511/DSECTION=causes
(2) http://emedicine.medscape.com/article/367452-overview (3)
http://www.asge.org/PatientInfoIndex.aspx?id=396 (4)
http://www.cdc.gov/cancer/colorectal/statistics/screening_rates.htm
(5) http://seer.cancer.gov/statfacts/html/colorect.html
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 1-212-867-1768 flazar@lazarpartners.com/
dcarey@lazarpartners.com
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