---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-033343"
form_type: "8-K"
ticker: "NUWE"
cik: "0001506492"
company_name: "Nuwellis, Inc."
filed_at: "2024-07-17T23:59:59+00:00"
generated_at: "2026-05-31T20:11:58.774604+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Nuwellis adds risk factor on off-label Aquadex use in neonates under 20 kg

## Summary
- Aquadex System cleared only for patients ≥20 kg, but is being modified for neonates/kidney failure infants.
- FDA may view company communications as off-label promotion, risking untitled letters, fines, or criminal penalties.
- Off-label promotion could trigger False Claims Act lawsuits, exclusion from Medicare/Medicaid, and corporate integrity agreements.
- Updated corporate presentation posted on IR website; no specific financial or strategic changes disclosed.

## SEC filing metadata
- accession: 0001140361-24-033343
- form_type: 8-K
- ticker: NUWE
- cik: 0001506492
- company_name: Nuwellis, Inc.
- filed_at: 2024-07-17T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1506492/000114036124033343/0001140361-24-033343-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1506492/000114036124033343/ef20032513_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-033343
- JSON: https://secwatch.observer/filing/0001140361-24-033343.json
- Plain text: https://secwatch.observer/filing/0001140361-24-033343.txt

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