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Pioneer Medical Innovations, Inc. currently has a 510K application prepared and will be submitting it to the FDA for approval to sell IncoFree in the United States. We expect to submit the application during the first quarter of 2009.
IncoFree (Contiform) holds a US patent.
Contiform has been approved to sell in the European Union. We are submitting a name change and packaging redesign for IncoFree. We expect approval and to begin sales in Europe during the second quarter of 2009.
Once approved in the US we will also be selling in Canada, Mexico, Central and South America.
PMI is a privately held company however from time to time there will be information released to the general public about our pending application, marketing, and current and new alliances with other companies.
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