News
3ive Labs Obtains Colombia Approval for its BIPASS-AKI 2 Study
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.
ReGelTec Successfully Treats First Eleven Chronic Low Back Pain Patients with HYDRAFIL™ in Colombia
ReGelTec, Inc., a medical device company developing a percutaneous treatment for chronic low back pain, announced today that eleven patients with degenerative disc disease have been enrolled in the Company’s Early Feasibility Study in Barranquilla, Colombia. The procedures were proctored remotely via Zoom, and all eleven patients were successfully treated with HYDRAFIL™. This patented hydrogel is melted before injection into the nucleus of a degenerated disc via a 17-gauge needle.