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CorMedix Inc. (CRMD) Seals Label Expansion for its Catheter Lock Solution

CorMedix, a specialty pharmaceutical company, charts its business strategy around developing products for the treatment of cardiac, renal and infectious diseases. With commercialization of these products being its general business goal, the company specifically endeavors to treat human disease by reducing commonly associated renal, cardiovascular, metabolic and infectious complications. CRMD’s therapeutic candidates include the likes of small molecules, chemical entities, biologics, devices and/or diagnostics that enable targeted therapy in these respective areas of interest.

Market opportunity for these products abounds. Patients meeting the challenges of hemodialysis need access to the vascular system in order to perform treatments on different schedules each week. In an article published by the American Journal of Kidney Diseases in February of 2008, there were 81,000 hemodialysis patients in the United States using the central venous catheter. One of the main complications in the use of a central venous catheter for hemodialysis treatment is CRBIs and the inflammation issues that arise as a result. With an estimate of two cases of CRBIs per patient per year, this would amount to over 160,000 cases each year. According the American Journal of Kidney Diseases, the total annual cost in the United States to treat CRBI episodes and their related complications would total approximately $777 million.

In recent news, CorMedix Inc. announced that TUV-SUD and The Medicinal Evaluation Board of the Netherlands (MEB) granted its request for a label expansion for its catheter lock solution, Neutrolin. The product was originally approved in July 2013 for use in the prevention of catheter-related bloodstream infections (CRBI) and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access.

Approval for additional indications for use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters is included in the label expansion. Additionally, the expansion includes patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). CRMD believes that the label expansion will enable additional critically ill patients to benefit from the expanded use of Neutrolin thus preventing infection and thrombosis.

CorMedix is a commercial-stage pharmaceutical company looking to develop, license and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix’s first commercial product in Europe is Neutrolin®, 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, in addition to oncology patients and critical care patients. Plans are moving forward to expand commercial distribution into the US, Asia, the Middle East, South America and Africa following appropriate regulatory approval.

For more information on the company, visit

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