AQUAPASS Secures Marketing Approval in Israel for New Fluid Management Therapy

AQUAPASS Receives Marketing Approval in Israel

AQUAPASS, a trailblazer in medical technology specializing in non-invasive fluid management solutions, has achieved a significant milestone by receiving marketing approval in Israel for its AQUAPASS System. This approval is a game changer for patients who experience fluid overload, which can severely impact their health, often leading to complications requiring immediate medical attention.

As AQUAPASS gears up for its initial rollout, the focus will be on collaborating with leading medical professionals in selected centers across Israel. This effort is aimed at gathering clinical feedback and generating real-world evidence that will facilitate broader use and long-term integration of the technology into patient care protocols.

The company’s pivotal clinical trial, REFORM-HF, is currently underway in the United States and Israel, exploring the effects of the AQUAPASS system on net fluid loss in patients with acutely decompensated heart failure. This population often struggles with ineffective responses to existing treatments and signifies a critical patient demographic for innovative interventions. Notable trial sites in the U.S. include Cone Health in Greensboro, NY, and the University of Minnesota Medical Center in Minneapolis among others, with the completion of enrollments targeted for the first quarter of 2026.

AQUAPASS's marketing approval signifies its transitional shift into commercial operations, which is pivotal for the company’s ambitions to expand internationally. As noted by Noam Josephy, CEO, this accomplishment underscores their commitment to improving the lives of patients affected by debilitating acute and chronic illnesses. The company is determined to provide revolutionary therapy aimed at fluid overload management, optimizing patient outcomes through advanced technological solutions.

Prof. Doron Aronson from Rambam Medical Center highlighted the critical nature of addressing fluid overload in cardiac cases, as it frequently leads to recurrent hospitalizations and declining quality of life. AQUAPASS brings forth a non-invasive philosophy that promises to transform patient management both in hospital settings and within the community.

The AQUAPASS system is noted for its capability to remove excess fluid in a manner that does not necessitate reliance on traditional diuretics or ultrafiltration. This novel approach aims to fill significant voids currently present in clinical practice, especially for patients with advanced kidney disease. Experts such as Prof. Ron Wald from St. Michael's Hospital have expressed optimism about the potential of AQUAPASS to redefine treatment pathways.

The REFORM-HF trial will rigorously evaluate the potential of AQUAPASS to enhance patient care by providing a reliable, non-invasive alternative for managing challenging cases of fluid overload. As emphasized by Dr. Scott Feitell, the principal investigator for the trial, many patients facing acute decompensated heart failure present complex treatment challenges, making effective therapeutics critical to improving their clinical outcomes.

Overall, AQUAPASS’s recent approval is a substantial stride in their mission to address fluid overload, positioning the company strategically for ongoing growth within the global medical technology landscape. The next critical steps involve initiating their commercial rollout in Israel while navigating the U.S. trial roadmap that aims for FDA clearance submission in mid-2026. With two Breakthrough Device Designations from the FDA and growing international recognition, AQUAPASS is on an upward trajectory to become a pivotal player in non-invasive fluid management therapy.