NEXTBIOMEDICAL Initiates U.S. Pivotal Trial for Nexsphere-F Microsphere Device in Knee Osteoarthritis
核心洞察
NEXTBIOMEDICAL (搜索) has enrolled the first patient in its U.S. FDA pivotal RESORB trial evaluating Nexsphere-F (搜索), a novel fast resorbable microsphere for knee osteoarthritis pain management.
The randomized controlled study will compare genicular artery embolization using Nexsphere-F (搜索) to intra-articular corticosteroid injections in approximately 126 patients across more than 10 U.S. clinical sites.
Published results from 155 patients demonstrated a 67% average pain reduction at 6 months with no device-related serious adverse events, supporting the device's safety and efficacy profile.
NEXTBIOMEDICAL (搜索) CO., LTD., a South Korean medical device company, has achieved a significant regulatory milestone with the enrollment of the first patient in its U.S. FDA pivotal clinical trial for Nexsphere-F (搜索)™, a novel fast resorbable microsphere designed for musculoskeletal pain embolization. The announcement marks a major advancement in the company's U.S. regulatory pathway following FDA approval of its Investigational Device Exemption (IDE).
RESORB Trial Design and Objectives
The pivotal trial, designated RESORB (Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain), will enroll approximately 126 patients across more than 10 leading U.S. clinical sites. The study is designed to compare genicular artery embolization (GAE) with Nexsphere-F (搜索)™ to intra-articular corticosteroid injections, with the primary goal of assessing both safety and efficacy in patients with painful knee osteoarthritis.
Regulatory Designations and Market Access
Nexsphere-F (搜索)™ has secured multiple key U.S. regulatory designations that position it for accelerated development and market access. The device has received 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.
Clinical Evidence and Real-World Performance
Beyond the U.S. regulatory pathway, Nexsphere-F (搜索)™ 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 6 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 (搜索)™ across diverse musculoskeletal conditions.
Technology and Mechanism of Action
The device leverages an innovative resorbable microsphere technology designed to temporarily occlude abnormal blood flow in pain-inducing vessels. The microspheres naturally dissolve within 2–6 hours, inducing targeted necrosis of nerve endings responsible for osteoarthritis pain and delivering rapid, sustained pain relief.
Commercial Traction and Market Outlook
Reflecting the accelerating market adoption, NEXTBIOMEDICAL (搜索) reported that overseas sales in Q3 2025 increased by approximately 40% compared to Q2 2025, highlighting strong commercial traction for Nexsphere-F (搜索)™.
"The enrollment of the first patient in the RESORB trial marks an important milestone in our U.S. regulatory strategy," said Ziv J. Haskal, MD, Professor at the University of Virginia and Chief Medical Officer of NEXTBIOMEDICAL (搜索). "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."
With the initiation of the U.S. pivotal trial, continued clinical expansion in Europe, and strong commercial growth, NEXTBIOMEDICAL (搜索) is advancing its mission to deliver a paradigm-shifting solution for musculoskeletal pain management and accelerating its path toward global commercialization.