[Edaily Reporter Kwon Oh-seok] Medical device company #NextBioMedical announced on the 18th that the results of a clinical study using its intravascular embolization device, “Nexsphere-F,” have been published in “Radiology,” a leading academic journal in the field of radiology.

The published paper, titled “Rapidly Degradable Gelatin Microsphere-Based Femoral Artery Embolization in Patients with Degenerative Knee Osteoarthritis,” was conducted by researchers at Charité – Universitätsmedizin Berlin in Germany. Charité is a global medical institution that ranked highly on Newsweek’s list of “World’s Best Hospitals 2026.”
The study is a prospective clinical trial involving 194 patients with degenerative knee arthritis who did not respond to conventional steroid and hyaluronic acid injections. It involved follow-up of patients according to predefined criteria and is evaluated as having a high level of clinical evidence due to its study design.
In particular, this study is considered significant as it is the largest prospective clinical trial to date involving femoral artery embolization (GAE) using degradable embolization materials, having simultaneously confirmed both therapeutic efficacy and safety.
The clinical results showed that all 239 procedures using NexSphere-F were successful, demonstrating high reliability in terms of procedural success rates. The NRS score, a pain assessment metric, decreased from an average of 7 before the procedure to 3 after 12 months, representing an improvement of more than half. Additionally, the KOOS index, which evaluates knee function and quality of life, showed significant improvement across all categories, with approximately 80% of patients experiencing clinically meaningful improvement.
Notable results were also observed in terms of safety. No serious procedure-related adverse events were reported, supporting its potential as a non-surgical treatment option.
The company expects these results to have a positive impact on its expansion into the European market. The clinical data obtained is expected to serve as evidence to facilitate future expansion of insurance coverage and adoption by medical institutions.
A NextBioMedical official stated, “This publication marks international recognition of the product’s clinical competitiveness,” adding, “We will continue to accumulate evidence through additional clinical trials currently underway in the U.S. and Europe to establish the product as a global standard of care.”