The multicenter study, called RESORB (Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain), will enroll about 126 patients at more than 10 U.S. clinical sites. The trial compares genicular artery embolization (GAE) using Nexsphere-F to intra-articular corticosteroid injections, assessing safety and efficacy for patients with knee osteoarthritis.

The launch of the trial follows FDA approval of an Investigational Device Exemption (IDE) for Nexsphere-F, which has also received Breakthrough Device Designation, CMS IDE Category B approval, and participation in the FDA’s Total Product Lifecycle Advisory Program (TAP). Those designations allow for accelerated regulatory review and Medicare coverage during the study.