CorMedix Catheter Infection Treatment Commercially Available in US
CorMedix Inc. (Nasdaq: CRMD) has announced that its DefenCath® (taurolidine and heparin) catheter lock solution (CLS) is now commercially available for inpatient use in the US. DefenCath® has received FDA approval for use in reducing the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.
CorMedix expects to begin outpatient commercialization of DefenCath on July 1, 2024.
Commenting on the news, Joseph Todisco, Chief Executive Officer of CorMedix, said, “Today opens a new chapter for healthcare providers, offering them an opportunity to reduce the risk of CRBSIs in a patient population already vulnerable due to underlying kidney failure. We are proud to provide an option for adult patients who face the risk of CRBSIs. We look forward to expanding the availability of DefenCath to the outpatient setting later this year.”
Outpatient commercial availability of DefenCath is contingent upon the Center for Medicare & Medicaid Services (CMS) approval and implementation of the Transitional Drug Add-On Payment Adjustment (TDAPA) application. CMS’ final HCPCS coding decision for DefenCath was published on April 2, 2024, establishing a new HCPCS Level II code for DefenCath. CorMedix is working with CMS on the TDAPA implementation process.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024, pending a timely implementation of TDAPA. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.
