Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced that it
has filed a U.S. Food and Drug Administration (FDA) application
seeking regulatory clearance to market its PillCam® COLON 2 for
visualization of the lower gastrointestinal tract.
"Filing for FDA clearance is another important milestone for
Given Imaging in advancing our efforts to commercialize PillCam
COLON 2. We believe that PillCam COLON 2 meets a significant unmet
need for a non-invasive imaging tool for visualization of the lower
GI Tract for physicians and their patients who are unable to
undergo colonoscopy or in cases of an incomplete colonoscopy," said
Homi Shamir, president and CEO, Given Imaging.
The PillCam COLON 2 capsule endoscopy system is complementary to
colonoscopy and the proposed indication for use meets an unmet need
and makes it an attractive imaging tool for patients who are at a
higher risk for complications from colonoscopy as well as for
patients who received an incomplete optical colonoscopy. The
diagnostic use of PillCam COLON 2 may improve the standard of care
for patients who are currently unable to undergo an exam, while
minimizing potential adverse events, and reducing the risks
associated with radiation-based alternative procedures such as CT
colonography or double-contrast barium enema.
Based on guidance provided by the FDA, Given Imaging has
submitted its PillCam COLON 2 application through a direct de novo
pathway. Under new guidelines specified by the FDA Safety and
Innovation Act (FDASIA) of 2012, the Company believes that the
direct de novo pathway may expedite the regulatory approval process
by a few months.
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 PillCam COLON 2 The PillCam COLON 2
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.
The risks of PillCam capsule endoscopy include capsule
retention, aspiration, or skin irritation. PillCam COLON capsule
endoscopy presents additional risks, including risks associated
with drug products used to prepare the patient for the procedure,
which are currently used for colonoscopy, including allergies or
other known contraindications to any preparation agents or
medications used for the PillCam COLON regimen, according to
laxative medication labeling and per physician discretion. 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, and Digitrapper®
pH-Z impedance, and the SmartPill GI 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 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. 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 ability of the Company to
reach agreement on any strategic alternative and/or to complete any
such alternative, as well as 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, 2011. 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)
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. 1-212-867-1762 flazar@lazarpartners.com
dcarey@lazarpartners.com Israel Investor Contact: Nava Ladin
Gelbart Kahana Investor Relations +972-3-6074717
nava@gk-biz.com
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