NEXTBIOMEDICAL CO. LTD. has recruited the first patient in its U.S. pivotal clinical trial evaluating Nexsphere-F, the company’s fast resorbable microsphere for musculoskeletal pain embolization. The study will compare genicular artery embolization (GAE) with Nexsphere-F to intra-articular corticosteroid injections to assess both safety and efficacy in patients with painful knee osteoarthritis.

Dubbed RESORB (Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain), the trial will enroll approximately 126 patients across more than 10 U.S. clinical sites.

This study enrollment milestone represents a significant advancement in NEXTBIOMEDICAL’s U.S. regulatory pathway, following U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval. Nexsphere-F has secured multiple U.S. regulatory designations, including FDA Breakthrough Device Designation, CMS IDE Category B approval, and participation in the TAP (Total Product Lifecycle Advisory Program). These designations enable accelerated review and Medicare coverage during the clinical trial phase, underscoring the potential of Nexsphere-F to address a major unmet need in osteoarthritis treatment.

Outside the United States, Nexsphere-F has obtained CE-MDD certification in Europe and is currently used in real-world clinical practice across multiple countries. Results from 155 patients treated with Nexsphere-F were recently published in the Journal of Vascular and Interventional Radiology (JVIR), demonstrating a 67% average pain reduction at six months, with no device-related serious adverse events reported. A separate study published in the Orthopaedic Journal of Sports Medicine (OJSM) highlighted the safety and potential of transcatheter arterial embolization for patellar tendinopathy (jumper’s knee). At CIRSE 2025 in Barcelona, German key opinion leaders and Dr. Yuji Okuno of Japan presented real-world clinical cases further reinforcing the strong safety and efficacy profile of Nexsphere-F across diverse musculoskeletal conditions.

“The enrollment of the first patient in the RESORB trial marks an important milestone in our U.S. regulatory strategy,” said Ziv J. Haskal, M.D., professor at the University of Virginia and chief medical officer of 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.”

NEXTBIOMEDICAL reported that overseas sales in Q3 2025 increased by approximately 40% compared to the second quarter, highlighting strong commercial traction for Nexsphere-F.

Nexsphere-F leverages a resorbable microsphere technology designed to temporarily occlude abnormal blood flow in pain-inducing vessels. The microspheres naturally dissolve within two to six hours, inducing targeted necrosis of nerve endings responsible for osteoarthritis pain and delivering rapid, sustained pain relief.

NEXTBIOMEDICAL is a medical device company based in South Korea. The company was established in 2014.