GIVN Seeks Japanese Approval - Analyst Blog
September 19 2012 - 11:45AM
Zacks
Specialist manufacturer of
gastrointestinal products, Given Imaging Ltd
(GIVN), recently filed for the regulatory approval of its second
generation visual capsule PillCam Colon 2 in Japan. The submission
to the Japanese Pharmaceutical and Medical Devices Agency (PMDA) is
supported by clinical trial data.
The trial evaluated the performance
of PillCam Colon 2 to observe the mucosal layer of the colon to
detect pathologies including colorectal cancer. Clinical studies
validated the improved efficiency of using PillCam Colon 2 over
standard colonoscopy, as the use of Given Imaging’s PillCam Colon 2
enabled clinicians to identify 94% polyps of at least 6mm in
size.
PillCam Colon 2 will be cleared for
commercialization in the U.S. only after the FDA approval and Given
Imaging expects to submit the clinical trials for FDA clearance in
the fourth quarter. However, the video capsule received the
European CE Mark in September 2009. It is also available in Latin
America, Canada and some parts of Asia.
Given Imaging expects to serve a
market of roughly one million annual procedures in Japan. Given the
significant addressable opportunity in the second largest market
for medical devices, management believes that PillCam Colon 2 may
help accelerate revenues.
Statistics suggest that about 88
million of the U.S. population over the age of 50 have a
probability of suffering from colon cancer. The annual compliance
rate is estimated to be in the band of 50% and 60% while the
compliance rate in the European and Japanese markets are
comprehensively lower. Based on these figures, Given Imaging sees a
$4 billion potential market for its PillCam Colon offering.
The company remains committed to
expand its geographic footprint. Revenues from the outside-U.S.
market represented 41% of its total revenues in 2011. However, the
company’s overseas operations make it susceptible to currency and
macroeconomic headwinds.
Given Imaging dominates the capsule
endoscopy market. With supportive market statistics and clinical
data, the company expects this second generation video capsule to
emerge as a major commercial opportunity. PillCam Colon 2 is also
expected to catalyze growth in the years ahead.
Given Imaging’s competitors
providing medical imaging solutions include Olympus
Corporations (OCPNY), GE Healthcare, a division of
General Electric (GE), and the privately-owned
FUJIFILM Holdings Corporation.
Given Imaging currently retains a
Zacks #3 Rank, which translates into a short-term Hold rating.
GENL ELECTRIC (GE): Free Stock Analysis Report
GIVEN IMAGING (GIVN): Free Stock Analysis Report
(OCPNY): ETF Research Reports
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