Full Press Release Details
CorMedix Provides an Update on CE Marking
Process for Neutrolin in the EU
Commercial Launch Targeted for 4Q2012/1Q2013
Bridgewater, New Jersey, June 14, 2012
(Business Wire) - CorMedix Inc. ("CorMedix") (NYSE Amex: CRMD), a pharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, announces the receipt of a request
for additional information and data, including six month stability data on the third and final test batch from TUV-SUD (the Testing
and Certification Group) and MEB-Netherlands (the Competent Authority) on the CE Mark application for Neutrolin
in the EU. Upon delivery of the requested information, the Company believes that Neutrolin will enter a third and
final round of review to finalize the CE Mark. CorMedix anticipates providing such additional information and data in late
3Q or early 4Q 2012. As a result, CorMedix now anticipates a final review and determination regarding its CE Mark application
by the end of 4Q 2012.
CorMedix is currently in the final stages
of completing its commercialization plan and is in discussions with several potential partners regarding the launch of Neutrolin
in Europe. Based on the status of such discussions CorMedix continues to target a commercial launch for 4Q 2012 / 1Q 2013.
CorMedix will host a conference call with
Richard M. Cohen and Randy Milby, the CEO and COO of the Company and Matthew P. Duffy, a member of CorMedix's Board who is leading
the company's commercial planning. The call will be held at 9:00AM, US EST June 15, 2012. The Dial-In number is 866-866-1333 or
CorMedix Inc. is a pharmaceutical company
that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac and renal
dysfunction, also known as cardiorenal disease. CorMedix most advanced product candidate: CRMD003 (Neutrolin ) for
the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous
catheters used for vascular access in hemodialysis patients. Please see www.cormedix.com for additional information.
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than
statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial
position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may
differ materially from projections or estimates due to a variety of important factors, including the outcome of clinical trials
of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; the risks and uncertainties
associated with: CorMedix's ability to manage its limited cash resources, obtaining additional financing to support CorMedix's
research and development and clinical activities and operations; obtaining regulatory approvals to conduct clinical trials and
to commercialize CorMedix's product candidates, including CE Marking for Neutrolin in Europe; CorMedix's ability
to enter into and maintain collaborations with third parties for its development programs; CorMedix's dependence on its collaborations
and its license relationships; achieving milestones under CorMedix's collaborations; CorMedix's' dependence on preclinical and
clinical investigators, preclinical and clinical research organizations, manufacturers and consultants; protecting the intellectual
property developed by or licensed to CorMedix; and CorMedix's ability to maintain listing on NYSE Amex. These and other risks are
described in greater detail in CorMedix's filings with the Securities and Exchange Commission. CorMedix may not actually achieve
the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements.
CorMedix disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after
the date of this press release.
Chief Operating Officer