REFORM-HF Pivotal Trial of Aquapass Eccon System for Fluid Overload Management Completes Enrollment

August 10, 2026—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 the FDA pivotal REFORM-HF trial for its Eccon system. Eccon is a wearable therapy designed to remove excess fluid directly through the skin as a complement to existing standards of care, stated the company.

According to Aquapass, the REFORM-HF 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.

The company advised that topline findings from REFORM-HF are expected to be presented in fall 2026 and will be submitted for publication in a peer-reviewed heart failure journal.

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

“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,” commented Dr. Feitell in the company’s press release. “We look forward to sharing what the data show this fall.”