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

Nuwellis, Inc.

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.

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