NEXTBIOMEDICAL Secures Health Canada Approval for Nexsphere-F™ in Musculoskeletal Pain Embolization

SEOUL, South Korea, Jan. 29, 2026 /PRNewswire/ -- NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, announced today that Nexsphere-F™, the company's novel fast resorbable microsphere for musculoskeletal pain embolization has received approval from Health Canada.

Nexsphere-F™ is a fast resorbable microsphere designed for musculoskeletal pain embolization. It temporarily occludes abnormal blood vessels associated with osteoarthritis-related pain using resorbable microspheres, inducing necrosis of pain-generating nerve cells within 2 to 8 hours after the procedure and effectively reducing pain. Unlike permanent microspheres, Nexsphere-F™ is designed to naturally dissolve after embolization, significantly lowering the risk of post-procedural complications and supporting the growing clinical demand for osteoarthritis pain embolization.

In addition to Canadian approval, Nexsphere-F™ is currently the only resorbable embolic microsphere certified under CE-MDD for osteoarthritis pain embolization, and is commercialized in major European countries. At CIRSE 2025, the annual congress of the Cardiovascular and Interventional Radiological Society of Europe, Dr. Florian Nima Fleckenstein (Charité-Universitätsmedizin Berlin, Berlin, Germany) presented, "Using rapidly resorbable, gelatin-based microspheres(Nexsphere-F™) for knee osteoarthritis pain embolization resulted in significant improvements in pain and function, while demonstrating favorable safety compared to permanent microspheres or antibiotic-based compounds." These findings were recently reported by Interventional News, a leading interventional radiology news.

Furthermore, a study published in Orthopaedic Journal of Sports Medicine (OJSM) highlighted the clinical efficacy and safety of Nexsphere-F™ for patients with patellar tendinopathy, a condition frequently seen in athletes. Additional clinical studies have reported its application in a wide range of musculoskeletal pain, including knee osteoarthritis, medial epicondylitis, plantar fasciitis.

The company is conducting multiple post-market clinical trials across several countries to further evaluate the efficacy and safety of Nexsphere-F™ for various indications, including osteoarthritis, patellar tendinopathy, elbow, wrist, plantar fasciitis, and other musculoskeletal conditions.

Nexsphere-F™ previously received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) and subsequently initiated a pivotal clinical trial for FDA approval, which is moving forward as planned. The study, named RESORB (Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain), is a multicenter, randomized controlled trial involving 126 patients with knee osteoarthritis across more than 10 U.S. clinical sites. The trial aims to evaluate the safety and efficacy of genicular artery embolization (GAE) with Nexsphere-F™ compared to intra-articular corticosteroid injections, with patient enrollment targeted to be completed within the first half of this year.

The company is currently in discussions with leading global partners regarding global distribution rights and is focusing its resources on accelerating the ongoing U.S. regulatory clinical trial to support successful entry into the North American market.

View original content to download multimedia:https://www.prnewswire.com/news-releases/nextbiomedical-secures-health-canada-approval-for-nexsphere-f-in-musculoskeletal-pain-embolization-302673688.html

SOURCE NEXTBIOMEDICAL CO., LTD.