NUWE Nuwellis, Inc.
Price Chart
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.
Actionable Insight
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.
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
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3309690 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 10, 2026
2d ago
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8-K
| $0.1440 awaiting T+1 | awaiting T+1 | — | $0.1400 (+2.78%) |
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Jun 10, 2026
3d ago
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Press Release
| $0.1440 awaiting T+1 | awaiting T+1 | — | $0.1400 (−2.78%) |
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Jun 9, 2026
4d ago
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Press Release
| $0.1458 awaiting T+1 | awaiting T+1 | — | $0.1400 (+3.98%) |
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Jun 8, 2026
4d ago
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424B4
| $0.1350 awaiting T+1 | awaiting T+1 | — | $0.1400 (−3.70%) |
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Jun 5, 2026
8d ago
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Press Release
| $0.3007 awaiting T+1 | awaiting T+1 | — | $0.1400 (+53.44%) |
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Jun 4, 2026
8d ago
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S-1/A
| $0.4300 $0.1700 | ▲ +60.47% | ▲ +57.87% | $0.1400 (+67.44%) |
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May 29, 2026
14d ago
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S-1/A
| $0.7000 $0.5900 | ▲ +15.71% | ▲ +15.86% | $0.1400 (+80.00%) |
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May 22, 2026
21d ago
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S-1
| $0.9100 $0.7600 | ▲ +16.48% | ▲ +16.50% | $0.1400 (+84.62%) |
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May 12, 2026
4w ago
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Press Release
| $1.03 $1.03 | · 0.00% | ▲ +0.58% | $0.1400 (+86.41%) |
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May 5, 2026
5w ago
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Press Release
| $1.11 $1.09 | ▼ −1.80% | ▼ −3.19% | $0.1400 (−87.39%) |
US Market Status
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