Aquapass System Approved in Israel for Fluid Overload Treatment

December 12, 2025—Aquapass, developer of noninvasive, kidney-independent solutions for fluid overload management in patients experiencing heart failure and chronic or end-stage kidney disease, announced marketing approval in Israel for the Aquapass system for the treatment of patients with fluid overload. The company noted that with the approval, Aquapass transitions into a commercial-phase company and establishes the foundation for its international growth.

According to Aquapass, the approval in Israel covers a broad clinical indication across cardiology, nephrology, and general medicine, supporting use in both acute and chronic patient populations.The company stated it will begin commercial deployment in selected medical centers across Israel and work with leading clinicians to collect clinical feedback and develop real-world evidence to support broader adoption and long-term integration into patient care.

Aquapass advised that the ongoing FDA pivotal REFORM-HF trial is enrolling at hospitals in both the United States and Israel. REFORM-HF is evaluating net fluid loss with and without the Aquapass system in patients with acutely decompensated heart failure who are not responding adequately to current medical treatment.

Completion of enrollment is targeted for Q1 2026 and a submission for FDA clearance is planned for Q2 2026.

REFORM-HF sites in the United States include Cone Health in Greensboro, North Carolina; Rochester Regional Health in Rochester, New York; University of Minnesota Medical Center in Minneapolis, Minnesota; Lenox Hill Hospital in New York, New York; Austin Heart in Austin, Texas; and UCSD Medical Center in San Diego, California.

The Principal Investigator of REFORM-HF is Scott Feitell, DO, Director of Advanced Heart Failure & Transplant Cardiology at Rochester Regional Health.

“Patients hospitalized with acutely decompensated heart failure, often accompanied by worsening renal function, are among the most challenging we treat,” commented Dr. Feitell in the company’s press release. “A noninvasive, kidney-independent option to treat fluid overload could expand our toolkit, help decongest these patients more reliably, and potentially improve outcomes. REFORM-HF is designed to rigorously evaluate that promise.”