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.
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|
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