NEXTBIOMEDICAL's Nexsphere-F™ Gains Health Canada Approval for Pain Management

Introduction

NEXTBIOMEDICAL CO., LTD., an avant-garde medical device enterprise headquartered in South Korea, has reached a significant milestone. On January 29, 2026, the company announced that its innovative product, Nexsphere-F™, has been granted approval by Health Canada. This novel medical device is specifically designed for embolization procedures aimed at alleviating musculoskeletal pain, a common ailment among many individuals.

What is Nexsphere-F™?

Nexsphere-F™ is recognized as a fast resorbable microsphere specifically developed for the embolization of pain associated with musculoskeletal disorders, particularly osteoarthritis. This revolutionary product operates by temporarily occluding abnormal blood vessels linked to osteoarthritis-related pain, leading to the targeted necrosis of pain-generating nerve cells. This mechanism results in pain reduction typically within 2 to 8 hours post-procedure.

One of the standout features of Nexsphere-F™ is its design, wherein the microspheres are engineered to dissolve naturally post-embolization. This characteristic markedly diminishes the potential for post-procedural complications, a concern frequently observed with traditional, non-resorbable microspheres. As demand for effective osteoarthritis pain embolization methods rises, Nexsphere-F™ provides a promising solution.

Global Reach and Recognition

In addition to receiving Canadian approval, Nexsphere-F™ is currently the only resorbable embolic microsphere to achieve CE-MDD certification specifically for embolization aimed at osteoarthritis pain relief in major European markets. Its international recognition was solidified at the CIRSE 2025 conference, where Dr. Florian Nima Fleckenstein from Charité-Universitätsmedizin Berlin presented findings indicating that the use of Nexsphere-F™ for knee osteoarthritis pain showed a significant improvement in both pain and function. What’s more, the safety of Nexsphere-F™ was noted to be superior when compared to permanent microspheres and antibiotic-based treatments.

Clinical Studies and Findings

A notable publication in the Orthopaedic Journal of Sports Medicine also underscores the clinical efficacy and safety of Nexsphere-F™ in treating patellar tendinopathy, a common injury among athletes. Clinical trials have indicated its effectiveness in addressing various musculoskeletal pain conditions, encompassing knee osteoarthritis, medial epicondylitis, and plantar fasciitis. These studies reinforce its potential as a versatile treatment option within the field of pain management.

Ongoing Trials and Future Goals

To further validate the efficacy and safety of Nexsphere-F™, NEXTBIOMEDICAL is undertaking multiple post-market clinical trials across different countries. These studies aim to explore the microsphere's application in treating an array of conditions beyond osteoarthritis, including other musculoskeletal challenges such as elbow and wrist pain.

In the United States, Nexsphere-F™ previously secured Investigational Device Exemption (IDE) approval from the FDA, enabling the commencement of a pivotal clinical trial known as RESORB. This randomized controlled trial will involve 126 participants with knee osteoarthritis across over ten clinical sites in the U.S., aiming to compare the safety and efficacy of genicular artery embolization using Nexsphere-F™ against standard corticosteroid injections. The trial's patient enrollment is scheduled to conclude within the first half of this year.

Strategic Partnerships and Market Insights

As NEXTBIOMEDICAL looks towards further expansion, it is engaged in negotiations with prominent global partners regarding distribution rights. Emphasis on accelerating clinical trials in the U.S. is a priority to facilitate a successful market entry into North America. The ongoing development and approval processes highlight the company's commitment to enhancing pain management solutions that resonate with clinical needs.

Conclusion

With Health Canada's approval now in hand and a robust portfolio of clinical support, Nexsphere-F™ stands poised to become a significant player in the field of pain management for musculoskeletal disorders. The path forward for NEXTBIOMEDICAL brims with potential as they continue their mission to offer innovative solutions that prioritize patient safety and treatment efficacy.

Call to Action

As the landscape of medical treatments evolves, stakeholders in healthcare, including practitioners and patients alike, should remain informed about emerging innovations like Nexsphere-F™. The continuous research and positive clinical outcomes of this breakthrough technology could redefine pain management standards in the near future.