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

Nuwellis, Inc.

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.

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