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CRMD > SEC Filings for CRMD > Form 8-K on 10-Jun-2013All Recent SEC Filings

Show all filings for CORMEDIX INC. | Request a Trial to NEW EDGAR Online Pro

Form 8-K for CORMEDIX INC.


Other Events

Item 8.01. Other Events.

CorMedix Inc. announces the following business developments:

· We have spoken to our lead regulator at TUV-SUD, the European Notified Body which is part of the regulatory CE Marking approval process in Europe, who informed us that our design dossier is complete. The committee that reviews the file for CE Mark approval is scheduled to review our file during the week of June 17, 2013 and is expected to render its decision before the end of June 2013. If granted, the CE Mark will enable us to commercialize Neutrolin® in the European Union (EU).

· Assuming receipt of the CE Mark, we plan to initiate a Neutrolin Use Monitoring Program. This monitoring program is designed to allow us to track relevant clinical and economic data in selected hospitals and clinics.

· The CorMedix Europe GmbH team is completing the Neutrolin commercialization plans for the EU which includes developing and testing of marketing materials, and preparations for attending a number of Congresses.

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