The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shield against hypoxia-induced damage under acute conditions.
JuxtaFlow combines a catheter and pump system. A trained urologist inserts the catheters in a manner similar to ureteral stent placement. Then, the catheter connects to the pump to deliver the negative pressure. Roivios designed the negative pressure to transmit through the nephrons, reducing downstream hydrostatic pressure. Controlled pressure reduction allows for effective filtration and selective reabsorption.
Roivios says breakthrough designation marks a significant leap forward in safeguarding kidney function for patients undergoing cardiac surgeries. It said in a news release that its platform addresses a key challenge in cardiothoracic surgery and critical care.
The company believes the technology can reduce ICU stays, minimize the need for emergency dialysis and enable savings for healthcare providers. Roivios expects a U.S. launch in late 2025.
“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,” said John Erbey, CEO of Roivios. “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.”
