SEOUL, South Korea, Oct. 13, 2025 — NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), a South Korea-based innovative medical device company, announced the enrollment of the first patient in its U.S. pivotal clinical trial evaluating Nexsphere-F™, a fast-resorbable microsphere for musculoskeletal pain embolization. The RESORB (Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain) trial aims to assess the safety and efficacy of genicular artery embolization (GAE) with Nexsphere-F™ in approximately 126 patients across more than 10 U.S. clinical sites. This milestone follows FDA approval of the Investigational Device Exemption (IDE) and represents a critical step toward U.S. regulatory approval and global commercialization.
Science Significance
Nexsphere-F™ leverages novel resorbable microsphere technology that temporarily occludes abnormal blood flow in pain-inducing vessels, inducing targeted necrosis of nerve endings responsible for osteoarthritis pain. The microspheres naturally dissolve within 2–6 hours, enabling rapid yet sustained pain relief. Real-world evidence supports its effectiveness: a study of 155 patients published in the Journal of Vascular and Interventional Radiology (JVIR) reported a 67% average pain reduction at six months with no device-related serious adverse events. Additional research in the Orthopaedic Journal of Sports Medicine (OJSM) highlights the safety and potential of transcatheter arterial embolization for patellar tendinopathy. Presentations at CIRSE 2025 in Barcelona, featuring cases from Germany and Japan, further reinforce the strong safety and efficacy profile of Nexsphere-F™ across musculoskeletal conditions.
Regulatory Significance
Nexsphere-F™ has received multiple key 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 FDA review and potential Medicare coverage during the clinical trial phase, reflecting regulatory confidence in the device’s innovative potential. Dr. Ziv J. Haskal, CMO of NEXTBIOMEDICAL and Professor at the University of Virginia, noted, “The enrollment of the first patient in the RESORB trial marks an important milestone in our U.S. regulatory strategy. With CE-MDD approval in Europe and a growing body of peer-reviewed evidence, we are confident this pivotal study will pave the way for FDA approval.”
Business Significance
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Beyond regulatory achievements, Nexsphere-F™ demonstrates accelerating market adoption, with overseas sales in Q3 2025 increasing by approximately 40% compared to Q2 2025. The device is already in clinical use across Europe under CE-MDD certification, and ongoing real-world data continue to validate its safety and efficacy. NEXTBIOMEDICAL’s commercial strategy combines clinical expansion, global regulatory positioning, and real-world adoption, positioning the company as a leader in the rapidly growing field of minimally invasive musculoskeletal interventions. The U.S. pivotal trial further strengthens the company’s roadmap toward broad market access and global commercialization.
Patients’ Significance
Knee osteoarthritis affects millions of patients worldwide, with limited non-surgical options that provide durable pain relief. Nexsphere-F™ offers a minimally invasive alternative to intra-articular corticosteroid injections, potentially reducing pain, improving mobility, and enhancing quality of life. The targeted embolization mechanism addresses the underlying vascular contributors to joint pain, rather than merely masking symptoms. Early clinical outcomes suggest rapid relief and long-term benefits, offering patients a safer, more effective treatment pathway than conventional interventions.
Policy Significance
With CMS IDE Category B approval and TAP participation, Nexsphere-F™ is positioned to receive Medicare coverage during its trial phase, potentially accelerating payer acceptance and reimbursement decisions. This model could inform future policy frameworks for minimally invasive devices addressing chronic musculoskeletal conditions, reinforcing the role of real-world evidence in regulatory and reimbursement strategies.
Transaction Highlights
The RESORB trial marks the enrollment of the first patient in the U.S. pivotal study for Nexsphere-F™, following FDA IDE approval and Breakthrough Device Designation. In Europe, Nexsphere-F™ holds CE-MDD certification and is already in clinical use, reflecting rapid international adoption. Published evidence from 155 patients demonstrated a 67% average pain reduction at six months, with no device-related serious adverse events reported. Commercially, NEXTBIOMEDICAL has seen a 40% increase in overseas sales in Q3 2025 compared to Q2, underscoring strong market traction. These milestones collectively position the company to accelerate regulatory approval, broaden clinical adoption, and expand global commercialization of its innovative musculoskeletal pain therapy.
Source: NEXTBIOMEDICAL CO., LTD. Press Release
