AQUAPASS Nears Finish Line with Novel Fluid Overload Wearable

NEWTON, MA and SHEFAYIM, ISRAEL – August 10, 2026 – Medtech developer AQUAPASS announced today that it has completed patient enrollment in its REFORM-HF pivotal trial, a critical step toward securing FDA marketing clearance for its ECCON System. The news signals that a potentially transformative, non-invasive therapy for fluid overload—a chronic and costly challenge for millions of patients with heart and kidney failure—is moving closer to reality. With topline results expected this fall, the industry is watching closely to see if this wearable device can succeed where decades of clinical research have fallen short.

The Crushing Weight of Fluid Overload

For patients with heart failure or chronic kidney disease, the body's inability to manage fluid balance is a constant, life-threatening battle. This condition, known as fluid overload or hypervolemia, is one of the leading drivers of hospitalization and readmission in modern healthcare, affecting over 17 million people and leading to more than 3 million hospital admissions annually. The economic and human costs are staggering.

When the heart or kidneys fail to remove excess fluid, it accumulates in the body, primarily in the extravascular or interstitial space. This leads to debilitating symptoms like severe swelling (edema), shortness of breath, and high blood pressure, dramatically reducing a patient's quality of life. The current standard of care primarily relies on diuretic medications to stimulate the kidneys to excrete more fluid. However, this approach has significant limitations. Many patients develop diuretic resistance, rendering the drugs ineffective, while high doses can lead to further kidney injury.

For those who don't respond to diuretics, the next step is often invasive mechanical fluid removal, such as ultrafiltration. Devices like Nuwellis's Aquadex system perform a function similar to dialysis, pulling blood from the body, filtering out excess water, and returning the blood. While effective, these methods require a large central line cannula, blood-thinning medications, and close clinical supervision, making them burdensome and reserved for acute, inpatient settings. The data reveals a persistent gap in care: despite these interventions, over 40% of patients are still discharged from the hospital in a congested state, fueling a vicious cycle of readmissions and adverse events. This is the challenging landscape AQUAPASS aims to reshape.

A New Paradigm: Removing Fluid Through the Skin

The innovation behind the AQUAPASS ECCON System lies in its elegant, yet powerful, mechanism of action. Instead of relying on the compromised kidneys or invasive blood filtering, the system removes excess fluid directly through the skin. The technology is a non-invasive, wearable system that envelops the patient's body and administers warm, dry air. This controlled environment gently stimulates the body's millions of eccrine sweat glands to significantly increase the rate of sweat production.

The genius of the approach is twofold. First, the fluid removed is sweat, which is drawn directly from the interstitial compartment—the body's primary reservoir of excess fluid in overload states. This targets the problem at its source. Second, the sweat evaporates instantly within the system, ensuring the patient remains dry and comfortable throughout the therapy. This kidney-independent pathway offers a novel solution for the very patients who are most difficult to treat with conventional methods.

By creating an alternative route for fluid removal, the ECCON System is positioned not as a replacement for diuretics but as a complementary therapy. The REFORM-HF trial specifically enrolled patients with acutely decompensated heart failure who were not responding adequately to standard medical treatment, underscoring its potential role as a crucial adjunct when first-line therapies fail. This non-invasive approach could fundamentally change the treatment algorithm, offering a less burdensome option before resorting to invasive procedures.

Navigating the Path to Market

Completing enrollment in a pivotal trial is more than a procedural step; it is a major inflection point for any medical device company. For AQUAPASS, it validates years of research and development and moves the ECCON System significantly closer to the U.S. market. The REFORM-HF trial (NCT06360380), conducted across 11 leading medical centers in the United States and Israel, was rigorously designed to measure net fluid loss, with each patient serving as their own control to strengthen the evidence.

"This is a major milestone for AQUAPASS and for the patients we aim to serve," said Noam Josephy, MD, CEO of AQUAPASS, in the company's announcement. "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."

The company's path has been bolstered by two FDA Breakthrough Device Designations. This program is reserved for technologies the agency believes could provide more effective treatment for life-threatening or irreversibly debilitating conditions. The designation provides prioritized review and more collaborative interaction with the FDA, potentially accelerating the timeline to market clearance.

Adding to the clinical confidence, the trial's Principal Investigator, Dr. Feitell, Director of Advanced Heart Failure & Transplant Cardiology at Rochester Regional Health, commented, "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."

The upcoming presentation of topline findings at a major heart failure conference will be a watershed moment. Positive data would not only pave the way for an FDA submission but would also generate significant interest among cardiologists and nephrologists eager for new tools to manage their most challenging patients. With marketing approval already secured in Israel, AQUAPASS has demonstrated an ability to navigate regulatory pathways, setting a promising precedent for its U.S. ambitions.