NEXT BIOMEDICAL, a local medical solution company, said it has received investigational device exemption (IDE) approval from the U.S. FDA for its musculoskeletal pain embolic therapy, Nexsphere-F.

The approved trial will be conducted as a multicenter, randomized, open-label study with 120 patients across 20 major U.S. university hospitals to evaluate Nexsphere-F's efficacy and safety. 

Nexsphere-F, a rapidly biodegradable embolic agent for musculoskeletal pain, targets abnormal blood vessels causing arthritis pain using fast-acting microspheres that break down within two to six hours. 

These microspheres induce necrosis in pain-causing nerve cells, reducing pain. Unlike non-biodegradable products, which can cause side effects such as skin discoloration, necrosis, and post-procedural pain, Nexsphere-F has garnered significant market interest. 

The company has already demonstrated its superior pain relief and safety in over 800 patients in Japan.

According to the company, Nexsphere-F is also the only treatment worldwide to receive the European CE-MDD certification for use in musculoskeletal pain embolization therapy, which has allowed the company to sign distribution agreements with multiple European distributors from the third quarter.

"With the FDA IDE approval, we have laid the foundation for full-scale entry into the U.S. market and anticipate further business discussions with global companies," a company official said. "We aim to accelerate our global market expansion and pursue strategic commercialization to dominate the musculoskeletal pain embolization therapy market."