Home / Health / Aquapass System Transforms Fluid Overload Treatment
Aquapass System Transforms Fluid Overload Treatment
9 Dec
Summary
- Aquapass received marketing approval in Israel for its fluid overload system.
- The system allows fluid removal directly through the skin, independent of kidney function.
- US FDA clearance submission is targeted for Q2 2026 after trial completion.
Aquapass has achieved a pivotal milestone with marketing approval for its AQUAPASS System in Israel, targeting patients suffering from fluid overload. This regulatory clearance enables the company to begin commercial deployment in Israeli medical centers, a crucial step from development to clinical application. The system is designed for diverse patient groups, including those with acute and chronic conditions across nephrology and cardiology.
CEO Noam Josephy highlighted this approval as a transition to the commercial phase, emphasizing the company's mission to aid critically ill patients. The AQUAPASS technology distinguishes itself by enabling direct fluid removal through the skin, bypassing the need for kidney function. This innovation holds promise for transforming fluid overload management, particularly for individuals with heart failure and kidney disease.
The company is actively pursuing further validation through its ongoing REFORM-HF trial, enrolling patients in both Israel and the US. Aquapass aims to complete enrollment by the first quarter of 2026 and submit for US Food and Drug Administration clearance in the second quarter of the same year. This strategic progression underscores Aquapass's commitment to expanding access to its innovative therapy.
