The Company is focused on developing its lead investigational drug product, Defencath™, a novel, antimicrobial and antifungal solution designed to prevent catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
Recently, the Company submitted the New Drug Application (NDA) for Defencath™ to the Food and Drug Administration (FDA). The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath. FDA will have a goal of a 6 month review period for priority review, compared to 10 months for a standard review. Defencath™ is already marketed as a CE Marked product in Europe and other territories under the brand name Neutrolin.
In parallel, CorMedix is researching how it can leverage its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active research programs in surgical sutures and meshes and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.