Insulet Receives CE Mark for the OmniPod(R) Insulin Management System

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Tue Apr 28, 2009 7:01am EDT

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

Stephanie Marks for Insulet Corporation, 1-877-PODD-IR1 (877-763-3471),
ir@insulet.com
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