CorMedix Inc. announced DefenCath®? (taurolidine and heparin) catheter lock solution (CLS) is now commercially available for U.S. inpatient use. DefenCath (taurolidine and Heparin) is approved by the U.S. Food and Drug Administration (FDA) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (HD-CVC).

The commencement of U.S. outpatient commercialization of DefenCath is planned for July 1, 2024. Outpatient commercial availability is contingent upon the Center for Medicare & Medicaid Services (CMS) approval and implementation of the DefenCath Transitional Drug Add-On Payment Adjustment (TDAPA) application in accordance with the agency's publicly stated objective that CMS aims for an effective date for applying the TDAPA for a particular product that is one quarter after the effective date of the HCPCS code for the product. The CMS Final HCPCS coding decision for DefenCath was published by CMS on April 2nd, establishing a new HCPCS Level II code for DefenCath, and CorMedix continues to work closely with CMS on the TDAPA implementation process.