#None #Health #Roivios #JuxtaFlow

Exciting Developments in Kidney Health

In a significant leap for kidney treatment innovation, Roivios, a clinical-stage medical device company, has announced promising results from the first human trial of its JuxtaFlow Renal Assist Device (RAD). This groundbreaking device aims to address unmet medical needs for patients suffering from acute decompensated heart failure and diuretic-resistant cardiorenal syndrome (CRS).

The Trial Overview

The trial, named VOID-HF (Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure), involved seven patients and was conducted across three centers in the U.S. The results, published in the ASAIO Journal, indicated that JuxtaFlow could significantly enhance urine output and sodium excretion while patients continued on standard diuretic therapy.

Key Findings to Note

1. Urine Output: A significant increase in mean 24-hour urine output was observed, rising from 2.27 liters to 3.85 liters (p = 0.027). This suggests that juxtaFlow effectively aids in fluid removal even when high doses of diuretics are administered.
2. Sodium Excretion: The mean sodium excretion also showed a notable increase, going from 78 mmol to 145 mmol (p = 0.032), indicating that the device enhances natriuresis and supports effective body decongestion.
3. Safety Profile: Encouragingly, no structural kidney abnormalities were detected in follow-up ultrasounds. While a few adverse events were noted, including transient hematuria and a reversible case of reflux anuria, the device was generally well tolerated.

Expert Commentary

Dr. Alex Parker, the lead investigator at the University of Florida, explained, "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." This feedback underlines the potential of JuxtaFlow in tackling critical renal challenges.

Addressing an Unmet Clinical Need

CRS is a prevalent condition affecting roughly 20% of patients hospitalized for acute decompensated heart failure, often leading to long hospital stays and an increased likelihood of progressing to dialysis. Current treatment options have yielded mixed outcomes, and the demand for effective new therapies has never been more urgent. Roivios' CEO, John Erbey, stated, "Clinicians urgently need new tools for patients who no longer respond to diuretics. 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 for Roivios

Building on these groundbreaking results, Roivios plans to expand their research with a larger, multicenter study designed to confirm the safety and efficacy of the device. This new study will also focus on refining treatment protocols and assessing critical clinical outcomes, including fluid balance, renal function, and hospital readmission rates.
Additionally, Roivios will explore the potential benefits of JuxtaFlow for cardiac surgery patients, which could present a transformative approach for managing fluid balance and enhancing recovery in this vulnerable demographic.

Conclusion

As the JuxtaFlow RAD is currently investigational and not available for commercial sale, there is still a journey ahead before it can transform patient care. However, the innovative strides made by Roivios hold promise for patients battling renal issues and expand the horizon of kidney health therapies. For more detailed information, the complete findings from the VOID-HF feasibility trial are accessible in the ASAIO Journal. Those interested in the progression of Roivios and JuxtaFlow can visit Roivios.com for updates.