Monitor for FDA submission timing and potential label expansion decision in late 2026 or 2027, which could open a larger pediatric addressable market. Near-term revenue impact is unclear without deal terms or ordering volumes.
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Executive Summary
Nuwellis announced an expansion of its collaboration with a South Carolina healthcare system, adding Aquadex SmartFlow devices at a children's hospital and upgrading existing sites to the latest devices. The news includes a pre-submission meeting with the FDA to expand the device's label to pediatric patients weighing 5 kg and above, with an anticipated submission by end of 2026.
Key Facts
- Expanded collaboration with a major South Carolina healthcare system to integrate Aquadex SmartFlow devices at a children's hospital
- Existing two locations already using the technology upgraded to latest Aquadex devices
- Nuwellis completed a pre-submission meeting with FDA to propose label expansion to pediatric patients 5 kg and above (currently 20 kg and above)
- Company anticipates submitting to FDA by end of 2026
- No financial terms, order quantities, or revenue impact disclosed
Financial Impact
No financial figures disclosed; revenue impact cannot be quantified from this press release
Risk Factors
- No financial details provided — actual revenue contribution from the collaboration is unknown
- FDA label expansion is not guaranteed and may be delayed or denied
- Nuwellis has very low market cap and may face funding challenges per forward-looking statements
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3309690 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 23, 2026 3d ago | 8-K | $0.3221 | awaiting T+20 | — | $3.07 (+851.69%) |
Sep 18, 2026 5w ago | SC 13G/A | $0.8700 $0.5600 | ▼ −35.63% | ▼ −34.72% | $3.07 (+252.34%) |
Sep 17, 2026 5w ago | Press Release | $1.09 $0.5532 | ▲ +49.25% | ▲ +50.45% | $3.07 (−181.23%) |
Aug 27, 2026 8w ago | EFFECT | $0.9900 $0.7915 | ▲ +20.05% | ▲ +19.95% | $3.07 (−209.64%) |
Aug 25, 2026 8w ago | 8-K | $1.01 $0.8700 | ▼ −13.86% | ▼ −15.06% | $3.07 (+203.50%) |
Aug 13, 2026 10w ago | Press Release | $1.30 $0.7740 | ▲ +40.46% | ▲ +38.71% | $3.07 (−135.80%) |
Aug 3, 2026 12w ago | 424B5 | $1.61 $0.7925 | ▲ +50.78% | ▲ +52.01% | $3.07 (−90.40%) |
Jul 31, 2026 12w ago | Press Release | $1.74 $0.8889 | ▲ +48.91% | ▲ +51.90% | $3.07 (−76.17%) |
Jun 16, 2026 18w ago | Press Release | $0.1350 $0.0840 | ▼ −37.78% | ▼ −37.83% | $3.07 (+2170.67%) |
Jun 10, 2026 19w ago | 8-K | $0.1520 $0.0869 | ▲ +42.86% | ▲ +46.93% | $3.07 (−1916.71%) |
US Market Status
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