BRIDGEWATER, N.J.--(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, 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.
Mr. Houghton added “the company is in discussion with several companies for potential strategic alliances as an option to commercialize Neutrolin in the European market next year.”
About CE marking
CE marking ensures the free movement within the European market of products that conform to the requirements of EU legislation (e.g. safety, health and environmental protection) and is a key indicator of a product’s compliance with legislation. The CE marking is affixed by manufacturers to their products. By placing CE marking on a product, manufacturers declare on their sole responsibility that the products comply with all the legal requirements in force in Europe. It is the manufacturer's responsibility to verify that the goods it is selling comply with all relevant legislation or – if necessary – to have it examined by a notified conformity assessment body for that purpose.
About Design Dossier
A design dossier is a technical file which is a comprehensive compilation of information and documents about a medical device. The following information is customarily included in a design dossier: description of the product, intended use of the device, manufacturing information and process, classification of the device and rationale, instructions for use and labeling and other design input specifications and essential requirements.
CRMD003, or Neutrolin®, is proposed as a catheter lock solution 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.
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: 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; 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.
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’s goal is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications, in effect, treating the kidney to treat the heart. CorMedix currently has several product candidates in development, including its two most advanced product candidates: 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; and CRMD001 (a proprietary formulation of deferiprone) for the prevention of contrast induced acute kidney injury in high-risk patients with chronic kidney disease. Please see www.cormedix.com for additional information.
Chief Financial Officer
KEYWORDS: United States Europe North America New Jersey
INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Pharmaceutical General Health