Newton, Massachusetts, USA & Shefayim, Israel, August 10, 2026
AQUAPASS, Inc. has announced the completion of enrollment in its FDA pivotal REFORM-HF clinical trial, marking an important milestone in the development of the company’s investigational ECCON System for fluid overload management in patients with heart failure and chronic or end-stage kidney disease. The noninvasive, wearable technology is designed to remove excess fluid directly through the skin, offering a kidney-independent approach to decongestion. Topline findings from the pivotal trial are expected to be presented at a major heart failure conference in fall 2026, with the company also planning to submit the findings for publication in a peer-reviewed heart failure journal.
REFORM-HF Completes Enrollment Across 11 Sites
The REFORM-HF pivotal trial (NCT06360380) was designed to evaluate net fluid loss in patients experiencing acutely decompensated heart failure who are not responding adequately to existing medical treatment. The study enrolled patients across 11 clinical sites in the United States and Israel, with each participant serving as their own control. Completion of enrollment allows AQUAPASS to move forward with data analysis and preparations for presentation and publication.The company described fluid overload as a major challenge affecting patients with heart failure and kidney disease and noted that it contributes substantially to hospitalization and readmission.
According to AQUAPASS, more than 40% of patients are discharged while still congested, contributing to continued clinical challenges and frequent readmissions. The company believes these persistent challenges highlight the need for additional approaches capable of safely removing excess fluid. The completion of enrollment represents a significant development milestone because REFORM-HF is the company’s FDA pivotal trial supporting the potential future marketing clearance of the ECCON System. AQUAPASS said it is now focused on completing its data analysis, preparing the clinical findings for presentation and publication, and advancing discussions with the FDA regarding potential next steps.
Wearable ECCON System Targets Fluid Overload
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The ECCON System is an investigational wearable therapy designed to remove excess fluid directly through the skin rather than relying on kidney function. AQUAPASS describes the technology as targeting the extravascular space, which the company identifies as the body’s primary reservoir of fluid during fluid overload. The approach is being developed as a non-invasive, kidney-independent complement to existing standards of care. This could be particularly relevant for patients with heart failure who also have chronic or end-stage kidney disease, where impaired kidney function can complicate the management of excess fluid.
AQUAPASS is developing the technology to address a significant unmet need in patients who experience fluid overload and do not respond adequately to current medical treatment. The company believes that a wearable system capable of removing excess fluid through the skin could potentially provide clinicians with an additional option for managing decongestion. However, the ECCON System remains investigational, and the company has not yet established its safety and effectiveness for commercial use through regulatory approval. The upcoming REFORM-HF data will be important in determining the clinical performance of the technology.
Topline Results Expected This Fall
Following completion of enrollment, AQUAPASS expects to present topline REFORM-HF findings at a major heart failure conference in fall 2026. The company also plans to submit the results for publication in a leading peer-reviewed heart failure journal, providing an opportunity for broader scientific evaluation of the pivotal study findings. AQUAPASS holds two FDA Breakthrough Device Designations for its technology and is continuing discussions with the FDA as it evaluates the regulatory pathway following the pivotal trial.
The company said its next activities will focus on analyzing the clinical data and preparing the results for scientific and regulatory review. The completion of REFORM-HF enrollment represents an important step in the development of noninvasive fluid overload therapy for patients with heart failure and kidney disease. The forthcoming clinical data will provide further insight into whether the ECCON System can offer a meaningful kidney-independent approach to decongestion and support AQUAPASS’s efforts toward potential FDA marketing clearance.
Source: AQUAPASS press release
