CorMedix Inc. Announces CMS Pass-Through Status for Defencath

In a significant milestone, CorMedix Inc., a biopharmaceutical company listed on Nasdaq under the ticker symbol CRMD, announced that the Center for Medicare & Medicaid Services (CMS) has granted pass-through status for their product DefenCath® under the hospital Out-Patient Prospective Payment System (OPPS). This status ensures separate payment under Medicare Part B for the use of DefenCath in outpatient settings for at least two years, extendable up to three years. Pass-through status is crucial as it guarantees that healthcare providers are reimbursed separately for administering DefenCath in ambulatory surgical centers or vascular access centers, offering a less invasive, outpatient-based alternative for patients needing vascular access for hemodialysis.

CorMedix estimates that about 100,000 HD-CVC placements occur annually, with about half of catheter-related bloodstream infections (CRBSIs) happening within the first 90 days of catheter insertion. Consequently, protecting the catheter line from the start is vital, and DefenCath plays an essential role in this regard.

DefenCath, a combination of taurolidine and heparin, is designed to reduce the incidence of CRBSIs in adult kidney failure patients undergoing chronic hemodialysis via a central venous catheter (CVC). However, it is intended for a specific, limited population. The product carries contraindications and precautions for patients with known heparin-induced thrombocytopenia (HIT) or hypersensitivity to any components of DefenCath, including taurolidine, heparin, citrate excipient, or pork products. If such exposure occurs, the use of DefenCath should be discontinued, and appropriate supportive measures should be taken.

For safety concerns or to report adverse reactions, healthcare professionals can contact CorMedix Inc. or the FDA through their respective hotlines or websites.

CorMedix, founded with a focus on developing and commercializing therapies for life-threatening diseases, has its lead product, DefenCath, approved by the FDA on November 15, 2023. The product was initially launched in inpatient settings in April 2024, with plans for expansion into outpatient settings by July 2024. The company also aims to extend the application of DefenCath as a catheter lock solution for broader patient populations.

As with many biopharmaceutical companies, CorMedix’s future projections and plans are subject to risks and uncertainties, and the company acknowledges that actual results may differ significantly from their forward-looking statements. These statements, often identified by terms like "anticipate," "expect," and "intend," are not guarantees of future performance and are influenced by several factors outlined in CorMedix’s SEC filings.

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