---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-033392"
form_type: "8-K/A"
ticker: "NUWE"
cik: "0001506492"
company_name: "Nuwellis, Inc."
filed_at: "2024-07-17T23:59:59+00:00"
generated_at: "2026-05-31T20:11:18.218002+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.25
calibrated_materiality_score: 0.25
confidence: "low"
source: SEC EDGAR
---

# Nuwellis adds off-label use risk factor and updates investor presentation

## Summary
- Filed 8-K/A to replace corporate presentation; updated version posted to investor website.
- Added risk factor detailing potential penalties from off-label promotion of Aquadex system, including use in neonates.
- Risk factor warns of FDA enforcement, False Claims Act suits, and exclusion from Medicare/Medicaid for off-label marketing.
- No changes to financial statements or other disclosures from prior 10-Q; no new business results provided.
- Company states its off-label communications are compliant but acknowledges regulatory authorities may disagree.

## SEC filing metadata
- accession: 0001140361-24-033392
- form_type: 8-K/A
- ticker: NUWE
- cik: 0001506492
- company_name: Nuwellis, Inc.
- filed_at: 2024-07-17T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.25
- calibrated_materiality_score: 0.25
- confidence: low
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1506492/000114036124033392/0001140361-24-033392-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1506492/000114036124033392/ef20032557_8ka.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-033392
- JSON: https://secwatch.observer/filing/0001140361-24-033392.json
- Plain text: https://secwatch.observer/filing/0001140361-24-033392.txt

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