), a leading tubeless insulin pump maker, has won 510(k) Food and
Drug Administration (FDA) approval for its next-generation
OmniPod Insulin Management System. Management is currently
preparing to launch the product in the U.S. sometime in late
first quarter of 2013.
The OmniPod Insulin Management System is a revolutionary,
discreet and easy-to-use insulin infusion system that features
two easy-to-use components with no tubing and a fully-automated
cannula insertion. The latest pump is more than one-third smaller
in size and one-quarter lighter in weight than the original
version introduced in 2005. It also incorporates an updated
Personal Diabetes Manager (PDM).
The FDA approval is likely to boost the company's core Omnipod
business in the U.S. Insulet is already generating strong
results, on the back of higher Omnipod sales, with revenues
increasing 23% in the last reported third quarter of
The company had been incurring incremental costs related to
the development and regulatory approval of the next generation
OmniPod insulin pump. Following the launch of this technically
advanced and user-friendly pump, we are optimistic that it will
generate revenue opportunity from the second quarter of 2013.
However, the device is likely to face strong competition from
larger players developing similar insulin delivery devices such
as Medtronic MiniMed, a division of
) and Animas Corporation, a division of
Johnson & Johnson
The company is heavily investing in training healthcare
professionals as well as patients regarding the new product,
which is likely to be a drag on the bottom line. Since its
inception, Insulet has incurred significant net loss and as of
December 2011, it had an accumulated deficit of $441.0
Massachusetts-based Insulet is an innovative medical device
company dedicated to improving the lives of people with diabetes.
Through the OmniPod System, Insulet seeks to expand the use of
continuous subcutaneous insulin infusion (CSII) therapy among
people with insulin-dependent diabetes.
We have a long-term Neutral recommendation on Insulet. The
stock currently retains a short-term Zacks #3 Rank (Hold
JOHNSON & JOHNS (JNJ): Free Stock Analysis
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INSULET CORP (PODD): Free Stock Analysis
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