Given Imaging's PillCam(R) COLON Cleared in Japan, World's Second Largest
Broad Indication Could Benefit Over One Million Patients Per Year in Japan
Significantly Broadens Given Imaging's Potential Capsule Endoscopy System
YOQNEAM, Israel, July 15, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd,
(Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer
of capsule endoscopy, today announced that PillCam® COLON has been cleared by
Japan's Pharmaceuticals & Medical Devices Agency (PMDA) for diagnosis of
colonic disease when colonoscopy is required but difficult to conduct,
including patients unwilling or unable to undergo colonoscopy.
A photo accompanying this release is available at
"We thank the PMDA for its very efficient review process and for granting a
broad indication for PillCam COLON," said Homi Shamir, President and CEO,
Given Imaging. "The clearance of PillCam COLON in Japan, the world's second
largest healthcare market, represents an important accomplishment for Given
Imaging. The decision could expand our potential customer base in Japan from
approximately 1,000 today to potentially 10,000 and will help in enhancing
adherence to screening guidelines for over 1,000,000 potential patients."
Screening guidelines in Japan call for everyone over 40 to undergo a fecal
occult blood test (FOBT). Compliance with screening remains low and only
approximately 25% of the population actually get tested.^1 After a physician
identifies blood in a patient's feces (which can be a strong indication of
colon cancer or other diseases), only 54.7% of these patients^2proceed to
have a recommended colonoscopy to confirm the diagnosis due to a variety of
reasons.PillCam COLON's ease of use and minimally-invasive profile could
appeal to those patients.
"The number of deaths due to colorectal cancer in Japan continues to increase
at an alarming rate," said Akira Terano, MD, PhD, Emeritus president, Dokkyo
Medical University, president, Japanese Association for Capsule Endoscopy
(JACE). "Colorectal cancer is now the leading cause of cancer death in women
in Japan and the incidence rate for colorectal cancer in men and women is
expected to be at the top of the list in the population of Japan by 2020.
PillCam® COLON is a less invasive medical device which would be able to drive
higher compliance. I believe that PillCam® COLON would make a huge
contribution for early detection and treatment of colon cancer by applying it
in the clinical setting. JACE would undertake the central role in research,
education and the upgrading of the medical system for the capsule endoscopy of
the colon. I believe PillCam COLON will be widely accepted into the clinical
practice for patients who are not able or unwilling to undergo a colonoscopy
due to physical or psychological reasons or who do not have a convenient
access to a medical (colonoscopy) facility near their place of residence."
"Our top priority is to provide physicians and patients with an alternative
colorectal exam option to ensure every patient, including those who are unable
or unwilling to get a colonoscopy, has the opportunity to undergo a colorectal
exam," Shamir said."Meaningful sales of PillCam COLON capsule will commence
immediately after obtaining reimbursement."
Reimbursement in Japan is expected to become effective during the first half
of 2014, subject to government discretion. PillCam COLON received the CE Mark
in September 2009 and is commercially available throughout Europe, Latin
America, Canada, and parts of Asia. PillCamCOLON is pendingU.S. Food and
Drug Administration (FDA)clearance and is not cleared for marketing or
available for commercial distribution in theU.S.and certain other countries.
^1 Ministry of Health, Labor and Welfare, 2007 Health Review of Japanese
^2 "Nationwide Survey Committee of Mass Screening for Digestive Organs of the
Japanese Society of Gastroenterological Cancer Screening: annual report of
2008 of the nationwide survey of mass screening for digestive organs," Journal
of Gastroenterol Cancer Screening, vol. 49, pp. 73-112, 2011.
About PillCam® COLON
The PillCam COLON 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 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
and skin irritation. The risks associated with colon preparation are allergies
or other known contraindication to any preparation agents or medications used
for the PillCam COLON regimen, according to laxative medication labeling and
per physician discretion. After ingesting the PillCam capsule and until it is
excreted, patients should not be near any source of powerful electromagnetic
fields, such as one created by an MRI device. Medical, endoscopic or surgical
intervention may be necessary to address these complications, should they
occur. A normal or negative capsule endoscopy examination does not exclude the
possibility of colon polyps or colon cancer.
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, 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.
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.
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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