---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-040128"
form_type: "8-K"
ticker: "CRMD"
cik: "0001410098"
company_name: "CorMedix Inc."
filed_at: "2023-05-16T23:59:59+00:00"
generated_at: "2026-06-14T23:29:02.847066+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# CorMedix resubmits DefenCath NDA to FDA for hemodialysis catheter infection prevention

## Summary
- NDA for DefenCath resubmitted to FDA as of May 15, 2023; agency acknowledged receipt for processing.
- CEO Joe Todisco said resubmission follows prior earnings call; company aims for potential approval in 2023.
- DefenCath is designed to reduce bloodstream infections in hemodialysis patients using central venous catheters.
- Resubmission addresses prior FDA feedback; no specific timeline for review decision provided.

## SEC filing metadata
- accession: 0001213900-23-040128
- form_type: 8-K
- ticker: CRMD
- cik: 0001410098
- company_name: CorMedix Inc.
- filed_at: 2023-05-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1410098/000121390023040128/0001213900-23-040128-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1410098/000121390023040128/ea178697-8k_cormedix.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-040128
- JSON: https://secwatch.observer/filing/0001213900-23-040128.json
- Plain text: https://secwatch.observer/filing/0001213900-23-040128.txt

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