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Nuwellis files 510(k) to extend Aquadex to children from 5 kg as losses narrow

🇺🇸 Nuwellis, Inc. (NUWE) · Thu 12 Nov 2026

The ultrafiltration specialist reported flat third-quarter sales of $2.2 million, a higher gross margin and a 24% smaller operating loss, alongside a pediatric filing and two distribution deals.

Nuwellis reported third-quarter 2026 results on 12 November, with net sales flat at $2.2 million. Gross margin improved to 69.5%, and the operating loss narrowed by 24% to $2.1 million.

The company said it has submitted a 510(k) premarket notification to the US Food and Drug Administration. The filing seeks to extend the Aquadex SmartFlow System to paediatric patients weighing 5 kg or more. The summary does not state the system's current indicated patient population, nor does it give a timeline for an FDA decision.

Nuwellis also signed distribution agreements for two third-party products: Atrility's AtriAmp and the Zorro-Flow paediatric urine collection system. No financial terms were provided in the material available.

Cash stood at $8.3 million at the end of the quarter. Nuwellis attributed this to a direct offering in July, a warrant exercise and sales under its at-the-market (ATM) programme.

As context, a 510(k) is the US pathway through which a manufacturer demonstrates that a device is substantially equivalent to a legally marketed predicate device. FDA clearance is required before marketing a device for a new indication.

What it means for your team

  • Regulatory teams should watch for FDA's response to the paediatric 510(k), as clearance would widen the Aquadex SmartFlow System's labelled use to patients of 5 kg and above.
  • Quality and PV teams at hospitals may need to prepare for paediatric-specific use, training and post-market surveillance if the indication is cleared.
  • Market-access teams can note the new distribution agreements for AtriAmp and Zorro-Flow, which broaden Nuwellis's portfolio around paediatric care, though commercial terms are undisclosed.
  • Flat sales and a $8.3 million cash balance, supported by equity financing, show the company is still reliant on capital markets while it pursues growth.

Company's press release (SEC filing): Nuwellis, Inc. ↗

Article written by VigiEye from the official source (Nuwellis, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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