CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced today that it submitted its design dossier to a prominent European notified body as part of the CE Marking approval process for Neutrolin in the prevention of Catheter Related Bloodstream Infections (“CRBI”) and maintenance of catheter patency in hemodialysis catheters.
The receipt of CE Marking approval will enable the company to market and sell Neutrolin in countries that accept CE Marking which include the 27 countries of the European Union.
CorMedix’s design dossier submission is a compilation of technical documents required as part of the CE Marking approval process. The design dossier will undergo review and audit by the European notified body. A Quality Management System (“QMS”) is currently being implemented by CorMedix and this will subsequently be audited by the notified body. A notified body is a European Union (“EU”) accredited third party authorized to conduct reviews and audits of medical device companies and their devices. Once the design dossier and QMS have been audited and approved by the notified body, a CE certificate will be issued. Further to the CE certificate issuance, a declaration of conformity, which is a legally binding document, must be prepared by the manufacturer stating that the device is in compliance with the applicable Medical Devices Directive in order to affix the CE Marking to the product.
“We are very pleased to have submitted the necessary documents to the notified body in order to continue to advance our CE Marking approval process for Neutrolin. Upon the successful audit and approval of the design dossier and the implementation and successful audit of the QMS, we would anticipate being in a position to obtain CE Marking approval in the first half of 2012,” stated President and Chief Executive Officer, John Houghton.