Nuwellis seeks FDA clearance for paediatric Aquadex use as sales hold at $2.2m

Nuwellis did not grow its top line in the third quarter of 2026. It reported net sales of $2.2 million in results published on 12 November. Profitability moved in the right direction: gross margin reached 69.5% and the operating loss was 24% lower, at $2.1 million.

The most consequential item for the pipeline is a 510(k) premarket notification submitted to the US Food and Drug Administration. It asks the agency to allow the Aquadex SmartFlow System to be used in paediatric patients weighing 5 kg or more. The material available does not say which patients the system is currently labelled for, and no decision date was given.

Nuwellis also signed distribution agreements covering two products made by other companies: Atrility's AtriAmp and the Zorro-Flow paediatric urine collection system. Financial terms were not disclosed, so it is not possible to say how much revenue either arrangement might add.

The company ended the quarter with $8.3 million in cash. It credited a July direct offering, a warrant exercise and sales through its at-the-market programme, all of which are forms of equity financing.

For context, a 510(k) is the route by which a manufacturer shows the FDA that a device is substantially equivalent to one already legally marketed. Clearance is required before a device can be promoted for a new indication.