NEWTON, Mass. and SHEFAYIM, Israel, Aug. 10, 2026 /PRNewswire/ — AQUAPASS, developer of a noninvasive, kidney-independent therapy for fluid overload management in patients experiencing heart failure and chronic or end-stage kidney disease, announced completion of enrollment in its FDA pivotal REFORM-HF trial, a key milestone on the path toward marketing clearance for its ECCON System.

Fluid overload is one of the most significant and costly challenges in modern healthcare, affecting millions of patients with heart failure and kidney disease, and standing as a leading driver of hospitalization and readmission.

Patients admitted with fluid overload frequently experience prolonged length of stay and high rates of adverse events. Despite decades of clinical research, >40% of patients are discharged in a congested state and have frequent readmissions. This persistent gap underscores the need for new approaches that can reliably and safely remove excess fluid, independent of the kidneys.

AQUAPASS developed a novel, wearable therapy designed to remove excess fluid directly through the skin — targeting the extravascular space, the body’s primary reservoir of fluid in overload — as a non-invasive, kidney-independent complement to existing standards of care.

The REFORM-HF (NCT06360380) pivotal trial was designed to evaluate net fluid loss in patients with acutely decompensated heart failure who are not responding adequately to current medical treatment. The study enrolled patients across 11 sites in the United States and Israel, with each patient serving as their own control.

REFORM-HF is being conducted at clinical sites across the United States — including locations in Rochester, New York; New York, New York; Greensboro, North Carolina; Asheville, North Carolina; Minneapolis, Minnesota; Columbus, Ohio; Austin, Texas; San Diego, California; and San Francisco, California — as well as at sites in Israel, in Petach Tikva and Haifa. A full list of participating study sites is available at https://clinicaltrials.gov/study/NCT06360380#contacts-and-locations 

“This is a major milestone for AQUAPASS and for the patients we aim to serve,” said Noam Josephy, MD, MSc, MBA, Chief Executive Officer of AQUAPASS. “We’re now focused on completing our data analysis, preparing for presentation and publication, and advancing our discussions with the FDA on the next steps toward clearance.”

Topline findings from REFORM-HF are expected to be presented at a major conference this fall, with findings also to be submitted for publication in a leading peer-reviewed heart failure journal.

“Completing enrollment in REFORM-HF is a significant milestone toward bringing a noninvasive, kidney-independent decongestion option to patients who often have few good choices left. We look forward to sharing what the data show this fall,” commented Dr. Feitell, Director of Advanced Heart Failure & Transplant Cardiology at Rochester Regional Health and the Principal Investigator of REFORM-HF.

AQUAPASS extends its sincere gratitude to the patients who participated in REFORM-HF, as well as to the investigators, study coordinators, research staff, and participating clinical sites whose dedication and commitment made this study possible.

About AQUAPASS

AQUAPASS is building the future of fluid overload therapy. The company’s non-invasive, wearable ECCON System removes fluid directly from the extravascular space through the skin, offering a kidney-independent approach to decongestion for patients with heart failure and kidney disease. AQUAPASS holds a broad and growing intellectual property portfolio and has been granted two FDA Breakthrough Device Designations. For more information, visit www.aquapass-medical.com.

*This release contains forward-looking statements regarding clinical development timelines, data presentation, and regulatory plans. Actual results may differ. The AQUAPASS System is investigational.

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SOURCE AQUAPASS, Inc.