CorMedix Inc. announced several commercial and operational updates related to its business and anticipated launch of DefenCath®. Recent Updates: CorMedix formally submitted an HCPCS application for a J-Code to the Center for Medicare and Medicaid Services (CMS) on December 8, 2023 for DefenCath, and CMS has confirmed the application is under review. The Company continues to engage in discussions with CMS related to the appropriate outpatient reimbursement structure for DefenCath and remains committed to its pursuit of separate payment under Medicare Part B as the appropriate reimbursement mechanism for the product.

In such an instance, the Company expects to establish a list price based on the market dynamics for both inpatient contracting as well as a Transitional Drug Add-On Payment (TDAPA) framework for outpatient reimbursement. CorMedix would then subsequently revise the list price downward should CMS make a determination in favor of separate payment under Medicare PartB. CorMedix expects to provide further detail on the DefenCath market opportunity as the company receive clarity from CMS regarding outpatient reimbursement.

The Company believes it has sufficient cash, cash equivalents and available resources to fund the commercial launch.