AQUAPASS REFORM-HF Pivotal Trial Meets Primary Endpoint, Demonstrating Significant Fluid Removal in Heart Failure Patients

AQUAPASS ECCON™ System delivered a >7x increase in net fluid loss in congested heart failure patients not responding to high-dose diuretics, with a consistently high responder rate (91%) and no device-related adverse events

NEWTON, Mass., Nov. 5, 2026 /PRNewswire/ -- AQUAPASS Medical, developer of a noninvasive, kidney-independent therapy, announced that the REFORM-HF (NCT06360380) pivotal trial met its primary effectiveness endpoint. The AQUAPASS ECCON™ System is a novel, skin-based approach to manage congestion and fluid overload in heart failure patients with persistent or worsening congestion who are unresponsive or resistant to current medical therapy.

The results were presented as a Late-Breaking Rapid Fire Scientific Session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 by the trial's National Principal Investigator, Dr. Scott Feitell, Novant Health Presbyterian Hospital. The results have also been presented at additional national meetings, including American Society of Nephrology (ASN) Kidney Week, AdvaMed and the TCT Acute Heart Failure Innovation Session.

REFORM-HF (NCT06360380) 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, a population with a large unmet need for new decongestion therapies.

The trial met its primary effectiveness endpoint. The mean change in Net Fluid Loss from each patient's own control day was an additional 785 g, averaged across the two treatment days (95% CI 686 to 884 g; p<0.0001 against the 500 g success threshold). Response was consistent across both treatment days and across the range of baseline kidney function. There were no device-related adverse events.

Fluid removed through the skin, not the kidneys

Congestion is a widespread problem in heart failure, leading to more than one million hospital admissions in the US every year.^{1 2} There are limited options for physicians to quickly and safely decongest patients. Increasing doses of diuretics are the traditional approach, however, kidneys stop responding to these drugs over time. That leads to more than 40% of patients discharged from the hospital congested,³ and 25% readmitted to the hospital within 30 days.⁴

The AQUAPASS ECCON™ System is designed to offer a new approach by harnessing the eccrine system and removing fluid through sweat using a wearable garment. This investigational system is a non-invasive approach that does not rely on kidney function to remove fluids.

"Fluid overload remains one of the most difficult problems we manage in heart failure," said Dr. Feitell, Director of Heart Failure and the Intensive Care Unit at Novant Health Presbyterian Hospital. "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."

"REFORM-HF was designed to answer a clear question, and the trial met its primary endpoint by a strong margin," said Noam Josephy, MD, Chief Executive Officer 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."

With the REFORM-HF Pivotal Study now complete, AQUAPASS is preparing its De Novo submission to the U.S. Food and Drug Administration (FDA) for the ECCON System.

The ECCON System is an investigational device, limited by United States law to investigational use. It is not cleared or approved by the FDA and is not available for sale in the United States.

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.

¹ Fonarow GC, et al. J Card Fail. 2026;32(2):439-498 (HF Stats 2025)
² Zafar MR, et al. Cureus. 2020;12(2):e6952
³ Abraham WT, et al. ESC Heart Fail. 2021;8(5):3472-3482
⁴ Dharmarajan K, et al. JAMA. 2013;309(4):355-363

SOURCE AQUAPASS, Inc.