Roivios Secures FDA Breakthrough Device Designation for JuxtaFlow® RAD, Showcases Pioneering Data at Society of Cardiovascular Anesthesiologists Annual Meeting

NASSAU, Bahamas, April 26, 2024 /PRNewswire/ — Roivios, a pioneering clinical-stage medical device company dedicated to transforming kidney health, is thrilled to announce it has been awarded the prestigious Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its cutting-edge JuxtaFlow® Renal Assist Device (RAD). This landmark recognition, fueled by the encouraging outcomes of the BIPASS-AKI feasibility study, coincides with the unveiling of pioneering research at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting. It marks a significant leap forward in safeguarding kidney function for patients undergoing cardiac surgeries, addressing a key challenge in cardiothoracic surgery and critical care.

The Breakthrough Device Designation emphasizes the JuxtaFlow® RAD’s potential to profoundly change the treatment paradigm for patients facing kidney disease during cardiac surgery. The device uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system to enhance function and shield against hypoxia-induced damage under acute conditions.

Highlighting the device’s transformative potential, Dr. Mark Stafford-Smith, a leading Professor of Cardiothoracic Anesthesiology at Duke University, stated, “It’s become clear that low oxygen levels in the kidneys during heart surgery are increasingly recognized as a predictor of acute kidney injury (AKI) and other complications after the operation. Despite numerous attempts with medications to address this issue, we’ve seen limited success. However, in our research where we replicated heart surgery on pigs, the JuxtaFlow® RAD device reduced both the intensity and duration of decreased kidney oxygen levels. This discovery opens up exciting new avenues for research and strategies to safeguard the kidneys in patients undergoing heart surgery.”

John Erbey, CEO of Roivios, reflected on the significance of this achievement saying, “Securing the Breakthrough Device Designation marks a crucial milestone for Roivios and underscores our dedication to advancing kidney health innovation.  We eagerly anticipate sharing the BIPASS-AKI clinical data soon.  We are proud to lead with innovative solutions like the JuxtaFlow® RAD, which not only supports our unique approach but also our commitment to improving outcomes across a wide spectrum of conditions.”

At the SCA Annual Meeting, Roivios will showcase the compelling preclinical data showcasing the impact of the JuxtaFlow® RAD on mitigating the harmful effects of cardiopulmonary bypass on the kidneys. This breakthrough is poised to reduce ICU stays, minimize the need for emergency dialysis, and generate substantial savings for healthcare providers.

With the anticipated U.S. launch of the JuxtaFlow® RAD in late 2025, Roivios is set to expand the device’s application beyond cardiac thoracic surgery, aiming to revolutionize kidney health management throughout the intensive care unit.

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

About Roivios
Roivios is a clinical-stage medical device company committed to pioneering solutions for kidney health. Our leading product, the JuxtaFlow® Renal Assist Device (RAD), is designed to preserve kidney function and offer a preemptive approach to managing kidney disease, demonstrating effectiveness in improving 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 in 2025, aiming to redefine kidney disease management and improve patient quality of life. 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, Krueger PR, [email protected]

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