Next Biomedical Co., a South Korean medical-device specialist, said it has received regulatory approval in Canada for its absorbable embolic microsphere used to treat musculoskeletal pain, a milestone the company says will accelerate its expansion into North America ahead of a planned U.S. launch.
The company said on Jan. 29 (local time) that Health Canada granted market authorization for Nexsphere-F™, an ultra-fast absorbable microsphere designed for transarterial embolization procedures targeting abnormal blood vessels associated with chronic musculoskeletal pain.
Nexsphere-F selectively blocks pain-inducing abnormal vessels and is engineered to naturally degrade and be absorbed by the body within approximately 2 to 8 hours after the procedure. The rapid absorption is intended to reduce post-procedure complications compared with conventional permanent embolic particles, while maintaining effective pain relief.
The device is positioned as a minimally invasive, intermediate treatment option that bridges the gap between steroid injections and surgery, particularly for conditions such as knee osteoarthritis, the company said.
The Canadian approval carries strategic significance. Canada is widely regarded as a market with stringent regulatory standards and is often used by medical-device makers as a stepping stone toward U.S. approval. Industry analysts say authorization from Health Canada helps validate product safety and quality in the eyes of North American regulators and clinicians.
Next Biomedical plans to use Canada as a forward base for broader North American expansion, including ongoing efforts to secure clearance from the U.S. Food and Drug Administration.
Nexsphere-F has already established a foothold in Europe. It is the only absorbable embolic microsphere approved under the CE-MDD framework for osteoarthritis pain embolization and is currently being commercialized in major markets including Germany and France.
Clinical data supporting the device continue to accumulate. At the Cardiovascular and Interventional Radiological Society of Europe meeting in 2025, physicians from Charité University Hospital in Berlin reported improved pain and functional outcomes in patients with knee osteoarthritis, along with a favorable safety profile compared with permanent embolic agents.
Additional clinical results have been published in international journals, including the Orthopaedic Journal of Sports Medicine, covering indications such as patellar tendinopathy. The company is also expanding post-marketing studies across multiple countries to broaden approved indications to conditions such as tennis elbow and plantar fasciitis.
In the U.S., Nexsphere-F has already received an Investigational Device Exemption from the FDA. Next Biomedical is currently conducting a pivotal clinical trial involving 126 patients with knee osteoarthritis. The study, known as RESORB, compares the safety and effectiveness of genicular artery embolization using Nexsphere-F with intra-articular steroid injections.
The company said it plans to accelerate regulatory trials, expand global partnerships and advance distribution talks as it moves toward full commercialization in North America.
