NextBiomedical this week announced it enrolled the first patient in its U.S. pivotal clinical trial evaluating its Nexsphere-F, a fast-resorbable microsphere for embolization treatment of musculoskeletal pain.
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.
“The enrollment of the first patient in the RESORB trial marks an important milestone in our U.S. regulatory strategy,” said Dr. Ziv J. Haskal, professor at the University of Virginia and chief medical officer at NextBiomedical. “With CE-MDD approval in Europe, thousands of successful procedures worldwide, and a growing body of peer-reviewed evidence through JVIR, OJSM, and international presentations, we are confident this pivotal study will pave the way for FDA approval and broader global adoption of our technology.”
Nexsphere-F is designed to temporarily block abnormal blood flow in pain-producing vessels. The microspheres dissolve naturally within two to six hours, targeting nerve endings linked to osteoarthritis pain to provide rapid, sustained relief.
The device holds CE-MDD certification in Europe and is used clinically in several countries. Published data from 155 treated patients in the Journal of Vascular and Interventional Radiology reported an average 67% pain reduction at six months with no device-related serious adverse events. Additional findings in the Orthopaedic Journal of Sports Medicine and presentations at CIRSE 2025 in Barcelona further supported its safety and performance.
NextBiomedical said overseas sales rose about 40% in Q3 2025 compared to the previous quarter, reflecting growing demand for Nexsphere-F as the company advances toward global commercialization of its resorbable embolic technology.
