CE Mark Enables Insulet to Begin Marketing In Europe
BEDFORD, Mass., April 28 /PRNewswire-FirstCall/ -- Insulet Corporation
(Nasdaq: PODD), the leader in tubing-free insulin pump technology, announced
today that the Company has received the CE Mark approval for its OmniPod(R)
Insulin Management System. The CE Mark gives Insulet authorization to
distribute the OmniPod System throughout the European Union and in other
countries that recognize the CE Mark.
"We are very pleased to have received the CE Mark for the OmniPod System,"
said Carsten Boess, Vice President of International at Insulet Corporation.
"The easy-to-use, tubing-free OmniPod System eliminates the obstacles that
often prevent people with diabetes from choosing the best treatment option,
insulin pump therapy. We are eager to be able to offer our innovative product
in Europe, where we have already received tremendously positive feedback from
key opinion leaders."
Insulet is in discussions regarding international distribution options for
the OmniPod System. The Company anticipates that the product will be
available to a limited extent in selected markets in 2009 with broader
availability in 2010.
The OmniPod Insulin Management System is the first and only continuous
insulin delivery system of its kind on the market. The OmniPod System offers
people living with insulin-dependent diabetes all the benefits of insulin pump
therapy, with unprecedented freedom, comfort and ease in managing their
diabetes. Unlike conventional insulin pumps, the OmniPod System has no tubing
and features automated, virtually pain-free insertion. It has just two,
wireless components: the Pod - a compact, lightweight, self-adhesive insulin
delivery device that is worn discreetly on the skin beneath clothing; and the
Personal Diabetes Manager - a wireless, menu-driven, hand-held device that
programs the Pod.
About Insulet Corporation
Insulet Corporation is an innovative medical device company dedicated to
improving the lives of people with diabetes. The Company's OmniPod Insulin
Management System is a revolutionary, discreet and easy-to-use insulin
infusion system that features two easy-to-use parts with no tubing and
fully-automated cannula insertion. Through the OmniPod System, Insulet seeks
to expand the use of insulin pump therapy among people with insulin-dependent
diabetes. Founded in 2000, Insulet is based in Bedford, MA.
Forward-Looking Statement
This press release contains forward-looking statements concerning
Insulet's expectations, anticipations, intentions, beliefs or strategies
regarding the future, including those related to Insulet's international
marketing efforts. These forward-looking statements are based on its current
expectations and beliefs concerning future developments and their potential
effects on it. There can be no assurance that future developments affecting it
will be those that it has anticipated. These forward-looking statements
involve a number of risks, uncertainties (some of which are beyond its
control) or other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include, but are not
limited to: risks associated with the Company's dependence on the OmniPod
System; Insulet's ability to increase customer orders and manufacturing
volumes; adverse changes in general economic conditions; potential supply
problems or price fluctuations with sole source or other third-party suppliers
on which Insulet is dependent; international business risks; Insulet's
inability to obtain adequate coverage or reimbursement from third-party payors
for the OmniPod System; potential adverse effects resulting from competition
with competitors; technological innovations adversely affecting the Company's
business; potential termination of Insulet's license to incorporate a blood
glucose meter into the OmniPod System; Insulet's ability to protect its
intellectual property and other proprietary rights; conflicts with the
intellectual property of third parties, including claims that Insulet's
current or future products infringe the proprietary rights of others; adverse
regulatory or legal actions relating to the OmniPod System;; unfavorable
results of clinical studies relating to the OmniPod System or the products of
Insulet's competitors; potential future publication of articles or
announcement of positions by physician associations or other organizations
that are unfavorable to Insulet's products; the expansion, or attempted
expansion, into foreign markets; the expansion of Insulet's distribution
network; Insulet's ability to successfully maintain effective internal
controls; and other risks and uncertainties described in its Annual Report on
Form 10-K, which was filed with the Securities and Exchange Commission on
March 16, 2009 in the section entitled "Risk Factors," and in its other
filings from time to time with the Securities and Exchange Commission. Should
one or more of these risks or uncertainties materialize, or should any of its
assumptions prove incorrect, actual results may vary in material respects from
those projected in these forward-looking statements. Insulet undertakes no
obligation to publicly update or revise any forward-looking statements.
SOURCE Insulet Corporation
CONTACT: Stephanie Marks for Insulet Corporation, 1-877-PODD-IR1
(877-763-3471), ir@insulet.com
(PODD)