Roivios Reports Promising Results from First-in-Human Trial of JuxtaFlow® Renal Assist Device

NASSAU, Bahamas, Dec. 12, 2025 /PRNewswire/ -- Roivios, a pioneering clinical-stage medical device company dedicated to revolutionizing kidney health, today announced promising results from the first human trial of its JuxtaFlow Renal Assist Device (RAD). This novel therapy has shown potential to improve outcomes for patients with acute decompensated heart failure and diuretic-resistant cardiorenal syndrome (CRS).

The VOID-HF (Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure) feasibility trial, published in the ASAIO Journal, enrolled seven patients across three U.S. centers. JuxtaFlow is designed to apply controlled negative pressure directly to the renal pelvis, enhancing urine output and sodium excretion while patients remain on standard diuretics.

Key Findings

• Urine Output: Mean 24-hour urine output increased significantly, from 2.27 L to 3.85 L (p = 0.027), demonstrating the device's ability to enhance fluid removal on top of high dose diuretics.
• Sodium Excretion: Mean sodium excretion increased significantly, from 78 mmol to 145 mmol (p = 0.032), suggesting enhanced natriuresis and effective decongestion.
• Safety: No structural kidney abnormalities were observed on follow-up ultrasound, and the device was generally well-tolerated. Transient hematuria and one reversible case of reflux anuria were the only notable adverse events.

"Applying negative pressure to the renal pelvis may help break the cycle of venous congestion and diuretic resistance that complicates care for hospitalized heart failure patients," said Dr. Alex Parker, lead investigator, University of Florida.

Addressing an Unmet Need
CRS affects roughly 20% of patients hospitalized for acute decompensated heart failure and is associated with high rates of diuretic resistance, prolonged hospital stays, and progression to dialysis. Current alternatives, including ultrafiltration, have yielded mixed results in randomized trials.

"Clinicians urgently need new tools for patients who no longer respond to diuretics," said John Erbey, CEO of Roivios. "The promising results from this first-in-human study reinforce the potential of JuxtaFlow to improve renal function where current therapies fall short."

Next Steps
Building on these breakthrough results, Roivios plans to initiate a larger, multicenter study to confirm safety and efficacy, refine treatment protocols, and evaluate key clinical outcomes such as fluid balance, renal function, and readmission rates. The study will also explore the potential of JuxtaFlow to support cardiac surgery patients, offering a novel approach to managing fluid balance and improving recovery in this critical population.

For more details, the full VOID-HF feasibility trial is available in the ASAIO Journal: Read the study here.

The JuxtaFlow RAD is currently investigational and is not yet available for sale. To learn more about Roivios and the JuxtaFlow Renal Assist Device, please visit Roivios.com.

About JuxtaFlow RAD
JuxtaFlow RAD is an investigational device designed to improve kidney function by applying mild, controlled negative pressure in the kidney's collecting system. Equipped with proprietary catheters and a pump system, JuxtaFlow optimizes filtration and supports renal recovery during critical periods. The device is currently under clinical investigation and is not available for sale.

About Roivios
Roivios is a clinical-stage medical device company dedicated to advancing kidney health. Its lead product, the JuxtaFlow RAD, aims to preserve kidney function, reduce the need for dialysis, and improve patient outcomes. With proprietary technologies and a commitment to innovation, Roivios is advancing toward larger clinical trials to transform kidney disease management. Discover more at roivios.com.

This release contains forward-looking statements subject to risks and uncertainties. Actual results may differ significantly.

Media Contact: Kelly Krueger, KPR Health, kelly@kpr-health.com

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