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.