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Nuwellis seeks FDA approval for pediatric use of Aquadex SmartFlow

Nuwellis completed a pre-submission meeting with the FDA on an indication expansion of its Aquadex SmartFlow system for pediatric patients from 5 kg and plans to file a 510(k) submission by the end of 2026. The approval strategy includes bench testing, toxicology assessments and clinical evidence, supported by publications from pediatric centers. The company positions the expansion for patients with fluid overload who require controlled ultrafiltration and highlights its positive liquidity relative to debt. The stock is trading near its 52-week low and is rated undervalued by one analysis. » Plus sur de.investing.com
Nuwellis reports quarterly and annual losses, revenue slightly down

For the quarter ended 31 December 2025, Nuwellis reported earnings per share (EPS) of -1.50 USD (prior year -18.480 USD) and revenue of 2.4 million USD (prior year 2.3 million USD). For the full year, loss per share was -25.390 USD (prior year -353.220 USD). Annual revenue fell 5.38 percent to 8.27 million USD from 8.74 million USD in the prior year. » Plus sur finanzen.net
Nuwellis raises revenue and improves margins after strategic withdrawal from foreign markets

Nuwellis reports Q4 2025 revenue of $2.4m (+4% YoY) and a gross margin of 68.2% (vs. 58.4% a year earlier). Console sales in the US rose 208%, while operating and net losses each remained $2.4m. The company is exiting less profitable international markets, refocusing on the cardiorenal continuum and plans to reintroduce the Clarity product in mid‑2026. Nuwellis reports a solid liquidity position with no debt but gives no concrete financial guidance for 2026. » Plus sur de.investing.com