Specialist manufacturer of gastrointestinal products,
Given Imaging Ltd
), 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
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
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
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
), GE Healthcare, a division of
), 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
(OCPNY): ETF Research Reports
To read this article on Zacks.com click here.