CorMedix Inc. Announces CMS Grants TDAPA to DefenCath

BERKELEY HEIGHTS, N.J., April 19, 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 that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath meets the criteria for a Transitional Drug Add-On Payment (TDAPA) in the anti-infective functional category, beginning on July 1, 2024. The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers, and aligns with CorMedix’s upcoming outpatient launch in July.

Joseph Todisco, Chief Executive Officer of CorMedix commented, “CMS determination of TDAPA eligibility for DefenCath is a critical step toward ensuring this innovative preventative drug product is available for patients in the outpatient dialysis setting. We are pleased that CMS was able to take timely action on our application for a July 1st effective date, and we intend to work closely with outpatient dialysis providers to ensure proper TDAPA implementation.”

DefenCath (taurolidine and heparin) catheter lock solution (CLS) 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). 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.