NextBioMedical Begins Pivotal RESORB Trial of Nexsphere-F Microsphere for Genicular Artery Embolization

October 13, 2025—NextBioMedical Co., Ltd., a South Korea–based developer of embolic materials for interventional pain and vascular therapy, announced that the first patient in the United States was enrolled in the company’s RESORB pivotal clinical trial of its Nexsphere-F microsphere, a device for musculoskeletal pain embolization.

According to NextBioMedical, the RESORB randomized controlled trial will evaluate the safety and efficacy of genicular artery embolization using Nexsphere-F versus intra-articular corticosteroid knee injection for osteoarthritic knee pain. The company initiated the trial after receiving approval of an investigational device exemption (IDE) from the FDA.

RESORB will enroll approximately 126 patients at more than 10 centers in the United States, advised the company.

NextBioMedical stated that the Nexsphere-F device employs a temporary occlusion mechanism to block pathologic microvasculature supplying pain-generating tissues. The microspheres fully dissolve within 2 to 6 hours, achieving targeted ischemia and sustained pain relief without permanent embolization.

The company noted that Nexsphere-F has received Breakthrough Device designation from the FDA, which was announced in January 2025; IDE Category B approval from the Centers for Medicare & Medicaid Services; and participation in the FDA’s Total Product Lifecycle Advisory Program.

Outside of the United States, Nexsphere-F holds CE Medical Devices Directive certification in Europe and is in clinical use across multiple countries, noted the company.

Additionally, the company reported that results from 155 patients treated with Nexsphere-F demonstrating a 67% mean reduction in pain at 6 months with no device-related serious adverse events were recently published in Journal of Vascular and Interventional Radiology; findings supporting the safety of embolization for patellar tendinopathy were published in Orthopaedic Journal of Sports Medicine; and real-world outcomes reinforcing the device’s safety and efficacy were presented in September at CIRSE 2025 by European and Japanese clinicians, including Yuji Okuno, MD.