Roivios has announced promising results from the first human trial of its JuxtaFlow renal assist device (RAD).
The therapy has shown potential to improve outcomes for patients with acute decompensated heart failure and diuretic-resistant cardiorenal syndrome (CRS).
The VOID-HF feasibility trial, published in the ASAIO Journal, enrolled seven patients across three US centres. 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.
The study showed that mean 24-hour urine output increased significantly, from 2.27L to 3.85L (p=0.027), demonstrating the device’s ability to enhance fluid removal on top of high dose diuretics. Mean sodium excretion increased significantly, from 78mmol to 145mmol (p=0.032), suggesting enhanced natriuresis and effective decongestion.
No structural kidney abnormalities were observed on follow-up ultrasound, and the device was generally well-tolerated. Transient haematuria 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 hospitalised heart failure patients,” said Alex Parker, lead investigator, University of Florida (Gainesville, USA).
CRS affects roughly 20% of patients hospitalised 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 randomised 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.”
Building on these breakthrough results, Roivios plans to initiate a larger, multicentre 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.
