Aquapass Medical has announced that the REFORM-HF pivotal trial—assessing the Aquapass Eccon system, a novel, skin-based approach to manage congestion and fluid overload in heart failure patients—met its primary effectiveness endpoint.
The results were presented as late-breaking research at the Heart Failure Society of America (HFSA) annual scientific meeting 2026 (9–12 October, Phoenix, USA) by the trial’s national principal investigator Scott Feitell (Novant Health Presbyterian Hospital, Charlotte, USA).
REFORM-HF (enrolled patients with chronic heart failure and persistent or worsening congestion despite high-dose loop diuretic therapy. More than 75% of enrolled patients had chronic kidney disease (CKD) stage 3 or 4.
The trial met its primary effectiveness endpoint. The mean change in net fluid loss from each patient’s own control day was an additional 785g, averaged across the two treatment days (95% confidence interval [CI] 686–884g; p<0.0001 against the 500g success threshold). Response was consistent across both treatment days and across the range of baseline kidney function. There were no device-related adverse events.
There are currently limited options for physicians to quickly and safely decongest patients. Increasing doses of diuretics is the traditional approach, however, kidneys stop responding to these drugs over time.
The Aquapass Eccon system is designed to harness the eccrine system and removefluid through sweat using a wearable garment. This investigational system is a non-invasive approach that does not rely on kidney function to remove fluids, Aquapass says in a press release.
“Fluid overload remains one of the most difficult problems we manage in heart failure,” said Feitell. “In REFORM-HF, the Eccon system delivered consistent, meaningful fluid removal through the skin, regardless of kidney function. These are very exciting results for heart failure patients who often have few options left.”
With the REFORM-HF pivotal study now complete, the company is preparing its de novo submission to the US Food and Drug Administration (FDA) for the Eccon System.
“REFORM-HF was designed to answer a clear question, and the trial met its primary endpoint by a strong margin,” said Noam Josephy, CEO of Aquapass. “We are grateful to the patients, investigators and site teams who put patients first at every step of this trial. We are now focused on our de novo submission to the FDA.”
