CorMedix announces FDA approval of DefenCath to reduce catheter-related bloodstream infections in hemodialysis patients

CorMedix Inc.

DefenCath (taurolidine and heparin) is the first FDA-approved antimicrobial catheter lock solution for adult hemodialysis patients.
Phase 3 LOCK-IT-100 trial showed a statistically significant 71% reduction in risk of CRBSIs (Hazard Ratio 0.29).
DefenCath is expected to be available in Q1 2024 in the inpatient setting.
The study enrolled 806 patients and early termination was recommended due to demonstrated efficacy.
CorMedix (CRMD) prepares for commercial launch with healthcare providers and facilities.

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