Nextbiomedical has announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its clinical trial RESORB featuring Nexsphere-F.
Designed to alleviate pain in knee osteoarthritis (OA) patients, the fast resorbable embolic microsphere will undergo a multicentre trial in the USA for market approval, marking a significant milestone in its global expansion strategy.
Knee OA is a debilitating condition affecting over 654 million people aged 40 and above globally, making it one of the leading causes of pain and disability among older adults. While existing treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs) and hyaluronic acid injections, provide temporary relief, their long-term efficacy is limited, and side effects are a significant concern. The RESORB trial aims to address these unmet needs by introducing a more sustainable and patient-friendly solution through genicular artery embolization (GAE) and Nexsphere-F.
RESORB is a multicentre, randomised, open-label study designed to assess how Nexsphere-F performs in alleviating pain and improving mobility in patients with knee osteoarthritis. The trial will enrol participants across leading healthcare institutions in the USA, focusing on the novel approach of GAE to treat OA-related symptoms.
Ziv J Haskal (University of Virginia, Charlottesville, USA) national principal investigator for RESORB, stated that Nexsphere-F has already received CE-mark approval for use in arthritis embolization, and has proven its superior safety and efficacy in thousands of musculoskeletal embolization patients in Asia and Europe. The company is actively seeking and securing its clinical trial sites for the US pivotal trial now.
Additionally, chief executive officer Don Haeng Lee emphasised that obtaining FDA approval for Nexsphere-F marks a pivotal milestone for the company, reflecting its commitment to advancing innovative medical solutions. He expressed pride in the successful completion of the essential IDE approval and shared optimism that the upcoming RESORB clinical trial will proceed seamlessly, paving the way for timely FDA approval. He further highlighted the company’s vision of making Nexsphere-F available globally to improve the quality of life for arthritis patients worldwide.
