3ive Labs Obtains Colombia Approval for its BIPASS-AKI 2 Study

Bogota, Colombia. On November 15, 2023, INVIMA, Colombia's regulatory agency, approved the BIPASS-AKI-2 early feasibility study by 3ive Labs, LLC (aka “Roivios™), with its JuxtaFlow ® (RAD) renal assist device at two research centers, one in Barranquilla, and the other one in Bucaramanga. This early feasibility study aims to recruit up to 40 subjects in Colombia and will last approximately 30 months. Roivios™ is a medical device company pioneering a novel renal assist device designed to reduce or eliminate acute kidney injury (AKI) in patients at elevated risk. Initially focused on meeting an unmet need for cardiac surgery associated-acute kidney injury (CSA-AKI) in the coronary artery bypass and surgical valve population, our pioneering renal assist device has the potential to address a range of poor outcomes. Roivios™ first product, the JuxtaFlow® Renal Assist Device, is the world’s first negative pressure renal assist device and features a catheter with unique energy delivery.

Source: INVIMA's Medical Device Committee, November 15, 2023 meeting minutes.