Aquapass has secured marketing approval in Israel for the AQUAPASS System, intended for patients experiencing fluid overload.
The approval allows the medical technology company to commence commercial deployment in selected medical centres across the country, with plans to gather clinical feedback and generate real-world evidence to support broader adoption.
It is said to cover clinical indications, including nephrology, cardiology, and general medicine, and supports use in both acute and chronic patients.
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Aquapass CEO Noam Josephy said: “This approval marks a pivotal transition for Aquapass — from bench to the bedside, and reinforces our commitment to serving patients worldwide.
“We are now a commercial-phase company with a clear mission: to serve the sickest acute and chronic patients. This achievement reflects the collective dedication, focus, and grit of our team, while putting patients first. We’ve taken a significant step toward transforming fluid overload management and therapy.”
Aquapass will continue its pivotal REFORM-HF trial, which is enrolling patients at hospitals in Israel and the US.
The study is designed to assess net fluid loss in patients with acutely decompensated heart failure who are not adequately responsive to standard medical therapy, comparing outcomes with and without the system.
The company has set a target to complete enrolment for the REFORM-HF trial by the first quarter of 2026, with plans to submit for US Food and Drug Administration (FDA) clearance in the second quarter of the same year.
In addition, Aquapass has received two breakthrough device designations from the regulator.
The company focuses on the development of kidney-independent solutions for managing fluid overload in those with heart failure and chronic or end-stage kidney disease.
Its technology allows for the direct removal of fluid from the interstitial space via the skin, without depending on kidney function.
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