---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-032876"
form_type: "8-K"
ticker: "CRMD"
cik: "0001410098"
company_name: "CorMedix Inc."
filed_at: "2023-04-26T23:59:59+00:00"
generated_at: "2026-06-16T12:22:36.069728+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# CorMedix to resubmit DefenCath NDA by mid-May; CMS proposes NTAP up to $17,111

## Summary
- Company will resubmit NDA for DefenCath to FDA by mid-May 2023 following Type A meeting.
- CMS IPPS 2024 proposed rule includes NTAP of up to $17,111 per hospital stay for DefenCath, conditional on FDA approval before July 1, 2024.
- Resubmission uses existing CMO and new heparin API supplier; expects 6-month Class 2 review.
- Company plans to add a 3 mL single-dose vial to commercial presentation based on market needs.
- NTAP amount based on 75% of WAC price ($1,170 per 3 mL vial) and average 19.5 vials per stay.

## SEC filing metadata
- accession: 0001213900-23-032876
- form_type: 8-K
- ticker: CRMD
- cik: 0001410098
- company_name: CorMedix Inc.
- filed_at: 2023-04-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1410098/000121390023032876/0001213900-23-032876-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1410098/000121390023032876/ea177512-8k_cormedix.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-032876
- JSON: https://secwatch.observer/filing/0001213900-23-032876.json
- Plain text: https://secwatch.observer/filing/0001213900-23-032876.txt

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