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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 System Transforms Fluid Overload Treatment

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.

Disclaimer: This story has been auto-aggregated and auto-summarised by a computer program. This story has not been edited or created by the Feedzop team.
The AQUAPASS System is approved in Israel for patients experiencing fluid overload, particularly those in nephrology and cardiology.
Aquapass's technology removes fluid directly from the interstitial space via the skin, without depending on kidney function.
Aquapass plans to submit for US FDA clearance in the second quarter of 2026.

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