#South Korea #Seoul #Osteoarthritis #NEXTBIOMEDICAL #Nexsphere-F™

NEXTBIOMEDICAL Initiates Pivotal Trial for Nexsphere-F™

On October 13, 2025, NEXTBIOMEDICAL CO., LTD., a South Korean company specializing in medical devices, made an important announcement regarding its clinical research efforts. The company reported the successful enrollment of its first patient in a pivotal clinical trial in the United States for its innovative treatment, Nexsphere-F™. This treatment is a groundbreaking fast resorbable microsphere specifically designed for patients suffering from knee osteoarthritis pain.

The initiation of this trial signifies a pivotal moment in NEXTBIOMEDICAL's U.S. regulatory strategy, particularly after receiving FDA approval for its Investigational Device Exemption (IDE). The trial is officially named the RESORB study, which stands for Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain. The study is set to involve approximately 126 participants at over ten leading clinical sites across the United States.

The RESORB trial aims to compare the efficacy and safety of genicular artery embolization (GAE) using Nexsphere-F™ against traditional intra-articular corticosteroid injections, which have been a longstanding option for alleviating knee pain caused by osteoarthritis. The primary objective is to determine the effectiveness of Nexsphere-F™ in relieving pain for patients with this chronic condition.

Nexsphere-F™ is gaining attention not only for its innovative approach but also for its favorable review by various U.S. regulatory bodies. The device has earned several key designations, including the FDA Breakthrough Device Designation and the CMS IDE Category B approval. This ensures an accelerated review process and Medicare coverage during the clinical trial, highlighting the importance and potential of Nexsphere-F™ in meeting a significant medical need for osteoarthritis management.

Internationally, Nexsphere-F™ has successfully received CE-MDD certification, which allows its use in various clinical practices across Europe. A recent study published in the Journal of Vascular and Interventional Radiology showcased that 155 patients treated with Nexsphere-F™ reported an impressive average pain reduction of up to 67% at the six-month mark, with no serious device-related adverse effects being documented.

Moreover, additional research presented in the Orthopaedic Journal of Sports Medicine underlined the safety and effectiveness of transcatheter artery embolization as a treatment strategy for conditions like patellar tendinopathy, commonly known as jumper's knee. At the CIRSE 2025 conference held in Barcelona, experts, including Dr. Yuji Okuno from Japan, reinforced the promising outcomes related to the safety and efficacy of Nexsphere-F™ across a variety of musculoskeletal issues.

Dr. Ziv J. Haskal, the Chief Medical Officer of NEXTBIOMEDICAL and a Professor at the University of Virginia, commented on this significant milestone: "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 thousands of successful procedures completed globally, we are optimistic that this study will facilitate FDA approval and foster broader global acceptance of our innovative solution."

The company’s sales numbers reflect a fruitful market uptake, especially reported overseas with a notable 40% increase in sales during the third quarter of 2025 compared to the preceding quarter. This aligns with the growing recognition and applicability of Nexsphere-F™ in the clinical setting.

The innovative design of Nexsphere-F™ revolves around its resorbable microsphere technology that effectively obstructs abnormal blood flow in vessels inducing pain. These microspheres dissolve naturally within 2 to 6 hours after administration, targeting specific nerve endings that are responsible for pain experienced in osteoarthritis. This offers rapid and long-lasting pain relief for patients.

As NEXTBIOMEDICAL advances its clinical trials in the U.S. and expands its presence in the European market, the company remains steadfast in its mission to transform musculoskeletal pain management, heralding a new era in treatment options for patients suffering from knee osteoarthritis.

In summary, the initiation of the RESORB trial marks a significant advancement for NEXTBIOMEDICAL and underscores the potential impact of Nexsphere-F™ on the future of osteoarthritis treatment.