FDA Grants IDE Approval For The Pivotal Trial Of The Juxtaflow® Renal Assist Device (RAD)

(MENAFN- PR Newswire)

Roivios Initiates Landmark Study to Demonstrate Safety and Efficacy of an Innovative Renal Assist Device for Cardiac Surgery Patients With Kidney disease

NASSAU, Bahamas, Dec. 19, 2024 /PRNewswire/ -- Roivios , a pioneering clinical-stage medical device company dedicated to revolutionizing kidney health, proudly announces that its research and development arm, 3ive Labs, has secured approval for an Investigational Device Exemption (IDE) from the FDA. This approval paves the way for a pivotal trial of the JuxtaFlow Renal Assist Device (RAD), marking a transformative step forward in enhancing outcomes for cardiac surgery patients with renal insufficiency.

The GRADIENT ( G roundbreaking R enal A ssist D evice I ntervening to EN hance cardio T horacic surgery outcomes) trial is designed to address the critical need for renal support among cardiac surgery patients undergoing cardiopulmonary bypass (CPB). These patients often face increased risks of postoperative complications, such as worsening renal dysfunction, which can lead to extended ICU stays and increased mortality.

"The GRADIENT Trial offers an invaluable opportunity to further explore renal support during cardiac surgery," said Dr. Evelio Rodriguez , a renowned heart surgeon at Ascension Saint Thomas in Nashville, TN, and the National Principal Investigator of the GRADIENT trial. "The JuxtaFlow device offers new hope for some of our most vulnerable patients."

JuxtaFlow RAD is an innovative device designed to potentially improve kidney function during times of acute stress. By applying a gentle suction to the kidney's outlet, it aims to enhance blood filtration more efficiently. This groundbreaking approach was recognized with an FDA Breakthrough Device Designation in April.

The GRADIENT study will be a prospective, multicenter, randomized, controlled, open-label trial that plans to enroll patients with renal insufficiency (eGFR 15-60 ml/min) undergoing elective or urgent cardiac surgery requiring CPB. The study seeks to evaluate the safety and effectiveness of the JuxtaFlow RAD to sustain or enhance renal function during and following CPB surgery.

"Achieving Breakthrough Device Designation was instrumental in securing IDE approval," noted John Erbey , Chief Executive Officer at Roivios. "This initiative is the culmination of a decade of technological and clinical advancements in addressing kidney disease management challenges. Our ongoing dialogue with the FDA is paving the way for more effective management, empowering patients to thrive. We are eager to commence IDE enrollment and explore the JuxtaFlow RAD's potential to improve surgical outcomes and enhance patient quality of life."

For more information about Roivios and the JuxtaFlow Renal Assist Device, please visit Roivios .

About JuxtaFlow RAD
The JuxtaFlow RAD is a pioneering investigational device set to transform kidney support therapy. Acknowledging the harmful effects of fluid accumulation and pressure on the kidneys, Roivios has advanced beyond traditional blood filtration methods that can further stress the kidneys. By applying mild, controlled negative pressure within the kidney's collecting system, the device has the potential to maintain and improve filtration and support recovery. This novel approach holds promise for a compelling value proposition by preserving kidney function and expediting patient recovery, ultimately reducing hospital stays and associated costs. Equipped with a proprietary specialized catheters and pump, the device optimizes kidney function during critical recovery periods, such as post-surgery. Currently, the JuxtaFlow RAD is under investigation and is not available for sale in any geography.

About Roivios
Roivios is a clinical-stage medical device company committed to pioneering solutions for kidney health. Our lead product, the JuxtaFlow Renal Assist Device (RAD), is designed to preserve kidney function and offer a proactive approach to managing kidney disease. We aim to demonstrate improved renal outcomes, potentially reducing the need for dialysis, and lowering healthcare costs. Holding proprietary patents in key kidney technologies, we aim to revolutionize kidney disease management. With plans to extend its application beyond kidney disease to various medical settings, Roivios is preparing for a transformative U.S. launch, aiming to redefine kidney disease management and improve patient quality of life. Discover more at roivios .

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

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Contact : Kelly Krueger, Krueger PR, [email protected]

SOURCE Roivios, ltd

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