AQUAPASS Receives Marketing Approval in Israel, Enabling Access to Novel Therapy for Patients with Fluid Overload

NEWTON, Mass. and SHEFAYIM, Israel, Dec. 8, 2025 /PRNewswire/ -- AQUAPASS, a medical technology company pioneering non-invasive fluid management solutions, has received marketing approval for the AQUAPASS System in Israel, marking a major milestone in bringing its novel therapy to patients suffering from fluid overload.

As part of the initial rollout, AQUAPASS will begin commercial deployment in selected medical centers across Israel, working closely with leading clinicians to collect clinical feedback and develop real-world evidence that will support broader adoption and long-term integration into patient care.

The ongoing FDA pivotal REFORM-HF (NCT06360380) trial, enrolling at hospitals in both the U.S. and Israel, continues. 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. U.S. sites include Cone Health (Greensboro, NC), Rochester Regional Health (Rochester, NY), University of Minnesota Medical Center (Minneapolis, MN), Lenox Hill Hospital (New York, NY), Austin Heart (Austin, TX), and UCSD Medical Center (San Diego, CA). The study is progressing, with enrollment completion targeted for Q1 2026 and submission for FDA clearance planned for Q2 2026.The approval covers a broad clinical indication across cardiology, nephrology, and general medicine, supporting use in both acute and chronic patient populations.

"This approval marks a pivotal transition for AQUAPASS — from bench to the bedside, and reinforces our commitment to serving patients worldwide," said Noam Josephy, CEO of AQUAPASS. "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."

Prof. Doron Aronson, Director, Cardiac Intensive Care Unit, Rambam Medical Center, Israel, added, "Fluid overload is a common and serious problem for cardiac patients, often leading to repeated hospitalizations and deterioration in quality of life. The AQUAPASS System provides a much-needed, kidney-independent, non-invasive approach that has the potential to change how we manage these patients both in the hospital and in the community."

Prof. Ron Wald, Director of Hemodialysis, St. Michael's Hospital, Toronto, Canada, and nephrologist, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, commented, "The ability to safely and effectively remove excess fluid without relying on diuretics or ultrafiltration represents a breakthrough for patients with advanced chronic kidney disease and kidney failure. AQUAPASS could address a major gap in current clinical practice."

Dr. Scott Feitell, Principal Investigator of REFORM-HF and Director of Advanced Heart Failure & Transplant Cardiology at Rochester Regional Health (Rochester, NY), said, "Patients hospitalized with acutely decompensated heart failure, often accompanied by worsening renal function, are among the most challenging we treat. A non-invasive, 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."

This approval marks AQUAPASS's transition into a commercial-phase company and establishes the foundation for its international growth strategy. In parallel, AQUAPASS continues to advance its U.S. clinical trial, REFORM-HF (NCT06360380), with the goal of submitting for FDA clearance in early 2026. The company has also been granted two FDA Breakthrough Device Designations and was recently featured at the Transcatheter Cardiovascular Therapeutics (TCT) conference, underscoring AQUAPASS's growing global recognition as an emerging leader in non-invasive fluid management.

About AQUAPASS

AQUAPASS develops non-invasive, kidney-independent solutions for fluid overload management in patients suffering from heart failure and chronic or end-stage kidney disease. The company's technology enables safe and efficient fluid removal directly from the interstitial space through the skin, independent of kidney function — improving outcomes and quality of life for patients worldwide.

For more information, visit www.aquapass-medical.com.

Key Facts

• Regulatory milestone: Marketing approval in Israel
• Scope: Broad indication across cardiology, nephrology, and general medicine
• Next phase: Initial commercial rollout with real-world data collection
• Strategic impact: Transition to commercial phase; REFORM-HF on track for Q1 2026 enrollment completion and Q2 2026 FDA submission
• Global recognition: Two FDA Breakthrough Device Designations and recent presentation at TCT 2025

SOURCE AQUAPASS, Inc.