NEXTBIOMEDICAL has earned U.S. Food and Drug Administration (FDA) breakthrough status for its Nexsphere-F resorbable microsphere for musculoskeletal pain embolization.

Nexsphere-F’s proposed indication is for use in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and/or analgesics by temporarily occluding blood flow in the genicular arteries.” It uses resorbable microsphere tech to deliver fast-acting microspheres into abnormal blood vessels responsible for arthritis pain.

The microspheres dissolve within two to six hours, leading to necrosis of pain-inducing nerve cells.

The company secured FDA approval for its investigational device exemption (IDE) and will launch its pivotal clinical trial at major U.S. university hospitals this year, with the target of abou 120 patients. It’s currently the only product approved under CE-MDD for musculoskeletal pain embolization and recently rolled out in key European markets.

This breakthrough designation allows Nexsphere-F to benefit from close collaboration with the FDA, allowing for prioritized review and expedited regulatory processes. Further, the designation offers greater flexibility in clinical trial design, accelerating the product’s market entry.

“Nexsphere-F has already been effectively used in thousands of MSK embolization patients worldwide,” said Dr. Ziv Haskal, National Principal Investigator of the RESORB Trial. “We expect to echo these outstanding results in the US trial.” The company is also in active discussions with global medical device companies for commercialization partnerships.