Nuwellis plans to expand Aquadex system into broader therapy platform

Nuwellis, Inc. (Nasdaq: NUWE) announced plans to develop its Aquadex SmartFlow System into a broader extracorporeal therapy platform, according to a press release issued Aug. 4, 2026.

The Minneapolis-based medical technology company said the development program is intended to enhance the system's operating parameters, including higher blood flow rates, expanded operating pressure ranges, and broader compatibility with extracorporeal therapies. The company said the initiative is aimed at expanding its addressable market beyond fluid overload into areas such as blood purification, immunomodulation, and extracorporeal life support.

Nuwellis said the expanded platform is anticipated to enable collaborations with developers of blood purification and other extracorporeal therapies.

"We believe Aquadex has the potential to evolve from a differentiated ultrafiltration system into a versatile extracorporeal therapy platform," said Mike McCormick, Nuwellis President and Chief Executive Officer.

The company noted that the development initiatives are research-stage applications not yet approved, cleared, or licensed by the U.S. Food and Drug Administration and are not currently available for commercial sale or clinical use.

The Aquadex SmartFlow System is currently cleared for continuous ultrafiltration therapy in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.

Nuwellis said it expects to provide future updates on technical milestones, regulatory strategy, and commercialization plans as the program advances.

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