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.
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.
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."
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