NextBioMedical Applies for FDA Breakthrough Device Designation for ‘Nexsphere-F’.

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NextBioMedical announced on the 10th that it has applied for Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) for Nexsphere-F, a resorbable embolic agent for musculoskeletal pain treatment.

 

The BDD program is designed to accelerate FDA approval for medical devices that demonstrate significant innovation and clinical importance over existing treatments. Devices granted BDD status receive priority review, expedited regulatory processes, and close collaboration with the FDA. Additionally, they may benefit from potential Medicare coverage, increased flexibility in clinical trial design, and faster market entry.

 

Nexsphere-F is a biodegradable embolic agent for musculoskeletal pain management. It works by embolizing abnormal blood vessels responsible for arthritis-related pain using rapidly resorbing microspheres, which degrade within 2 to 6 hours. This process induces necrosis in pain-causing nerve cells, thereby reducing pain. The device has already received Investigational Device Exemption (IDE) approval from the FDA, and a clinical trial involving approximately 120 patients at major U.S. university hospitals is set to begin this year.

 

Traditional non-degradable embolic agents have been associated with side effects such as pain, skin discoloration, and necrosis, leading to increased demand for biodegradable alternatives in the arthritis pain embolization market. Nexsphere-F is currently the only CE-MDD-approved embolic agent available for musculoskeletal pain treatment. It was recently launched in major European markets and is under commercialization discussions with global medical device companies. In January, clinical trial results were presented at the GEST MSK (Global Embolization Symposium & Technologies – Musculoskeletal) conference in Europe, drawing significant attention from medical experts and professionals worldwide.

 

A NextBioMedical representative stated, "If our application for BDD is approved, we expect a significantly accelerated FDA approval process. This designation will also enhance our collaboration with global medical device companies and positively impact our business expansion."