---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-087921"
form_type: "8-K"
ticker: "CRMD"
cik: "0001410098"
company_name: "CorMedix Inc."
filed_at: "2023-11-16T23:59:59+00:00"
generated_at: "2026-06-08T01:03:26.790026+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-23-087921
- form_type: 8-K
- ticker: CRMD
- cik: 0001410098
- company_name: CorMedix Inc.
- filed_at: 2023-11-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1410098/000121390023087921/0001213900-23-087921-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1410098/000121390023087921/ea188579-8k_cormedix.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-087921
- JSON: https://secwatch.observer/filing/0001213900-23-087921.json
- Plain text: https://secwatch.observer/filing/0001213900-23-087921.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.