The provider has also upgraded to the latest Aquadex devices at its two locations that already use the technology, helping clinicians provide controlled, predictable fluid removal for pediatric patients.

"Expanding this important collaboration will bring our Aquadex therapy to more pediatric patients in need," said Nuwellis' CEO John Erb. "This further validates Nuwellis' ultrafiltration system as a clinically important and increasingly adopted solution for managing fluid overload, while reinforcing our growing leadership and continued momentum in the pediatric category."

Nuwellis' Aquadex system is designed to provide precise ultrafiltration therapy for adult and pediatric patients weighing 20 kg and above who are suffering from fluid overload. The therapy supports improved patient management and may help reduce rehospitalizations associated with heart failure and related conditions.

Nuwellis recently completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) to propose expansion of the Aquadex SmartFlow® System's label to support pediatric patients weighing 5 kg and above. The Company anticipates submitting to the FDA by the end of 2026.