CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath (Taurolidine and Heparin)

BERKELEY HEIGHTS, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today 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).

Joseph Todisco, Chief Executive Officer of CorMedix commented, “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.”

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 2^nd, establishing a new HCPCS Level II code for DefenCath, and CorMedix continues to work closely with CMS on the TDAPA implementation process.

To learn more about DefenCath, visit DefenCath.com.

DefenCath (taurolidine and heparin)
IMPORTANT SAFETY INFORMATION

These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.

LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

DefenCath is contraindicated and has warnings and precautions in patients with:

• Known heparin-induced thrombocytopenia (HIT).
• Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.

If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.