The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical’s randomised trial involving its fast-resorbable embolic microsphere, Nexsphere-F, in treating knee osteoarthritis (OA).
The multi-centre, open-label RESORB trial will focus on providing a ‘sustainable’ and ‘patient-friendly’ treatment option through the system and genicular artery embolisation (GAE).
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It will enrol subjects across various US healthcare institutions to demonstrate the performance of the system in easing pain and improving mobility for OA subjects, leveraging the GAE approach to treat symptoms associated with OA.
RESORB national principal investigator and University of Virginia Interventional Radiology professor Dr Ziv Haskal said: “Nexsphere-F has already received CE-MDD approval for use in arthritis embolisation, and has proven its superior safety and efficacy in thousands of musculoskeletal embolisation patients in Asia and Europe.”
NextBioMedical is currently in the process of securing sites for the pivotal US study.
Nexsphere-F is composed of a hydrophilic material and is tailored for use in endovascular embolisation procedures. It blocks target blood vessels upon injection and is completely resorbed by the body over time, offering a safe treatment option with a minimised risk of complications.
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By GlobalDataIt is estimated that OA affects over 654 million individuals aged 40 years of age and older worldwide, leading to pain and disability. Current treatments such as hyaluronic acid injections and non-steroidal anti-inflammatory drugs (NSAIDs) offer temporary relief but have side effects with limited long-term efficacy, the company noted.
South Korean medical device company NextBioMedical develops therapeutic materials and drug-device combination products.
Its other flagship product, Nexpowder, has received approval from the FDA for its rapid bleeding control. The company continues to invest in research and development to address medical challenges.
