Roivios Releases Clinical Data on the JuxtaFlow RAD

Roivios, a pioneering clinical-stage medical device company dedicated to revolutionizing kidney health, has announced new clinical data from the BIPASS-AKI Feasibility Study of the JuxtaFlow Renal Assist Device (RAD). The study met its objectives, revealing its potential to enhance renal function post-cardiac surgery with cardiopulmonary bypass.

The study aimed to evaluate the safety and feasibility of the JuxtaFlow RAD, a novel device designed to sustain or enhance renal function immediately following such surgeries. This marked the first use of the JuxtaFlow RAD in a surgical setting. 

John Erbey, CEO of Roivios, stated, “This study tested the initiation of the JuxtaFlow RAD nearly two hours after patients were weaned from cardiopulmonary bypass, likely after the insult to their kidneys already occurred. The results highlight the potential of JuxtaFlow RAD in enhancing postoperative recovery.”

The average device placement time was 35 +/- 15 minutes post-surgery. Catheters were successfully placed in 100% of subjects under fluoroscopic guidance and 83% without fluoroscopy. Treatment initiation occurred 104 +/- 30 minutes after surgery completion.

In terms of efficiency, only two of the ten patients treated with the RAD experienced a postoperative AKI, with one of these cases resulting from a protocol deviation. No cases of gross hematuria were seen, and no adverse events were linked to the device’s active energy.

Dr. Evelio Rodriguez, chief of cardiothoracic surgery at Nashville’s St Thomas Hospital, presented the study’s findings at a conference poster session at the STS Perioperative Care meeting in Philadelphia.