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NEXTBIOMEDICAL Announces First Patient Enrolled in U.S. FDA Pivotal Trial of Nexsphere-F™ for Knee Osteoarthritis Pain
NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, today announced the enrollment of the first patient in its U.S. pivotal clinical trial evaluating Nexsphere-F™, the company's novel fast resorbable microsphere for musculoskeletal pain embolization. This milestone represents a significant advancement in NEXTBIOMEDICAL's U.S. regulatory pathway, following FDA approval of its Investigational Device Exemption (IDE). The pivotal trial, known as RESO
About this update from Nextbiomedical Co. Ltd.
[{"type":"list","items":[{"val":[{"type":"text","content":"RESORB Study Marks Major Step Toward U.S. Regulatory Approval and Global Commercialization","length":90,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":90,"olType":false},{"type":"text","content":"SEOUL, South Korea, Oct. 13, 2025 /PRNewswire/ -- NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, today announced the enrollment of the first patient in its U.S. pivotal clinical trial evaluating Nexsphere-F™, the company's novel fast resorbable microsphere for musculoskeletal pain embolization. This milestone represents a significant advancement in NEXTBIOMEDICAL's U.S. regulatory pathway, following FDA approval of its Investigational Device Exemption (IDE). The pivotal trial, known as RESORB (Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain), will enroll approximately 126 patients across more than 10 leading U.S. clinical sites. The study is designed to compare genicular artery embolization (GAE) with Nexsphere-F™ to intra-articular corticosteroid injections, with the primary goal of assessing both safety and efficacy in patients with painful knee osteoarthritis. Nexsphere-F™ has already received multiple key U.S. regulatory designations, including FDA Breakthrough Device Designation, CMS IDE Category B approval, and participation in the TAP (Total Product Lifecycle Advisory Program). These designations enable accelerated review and Medicare coverage during the clinical trial phase, underscoring the potential of Nexsphere-F™ to address a major unmet need in osteoarthritis treatment.","length":1470,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/NEXTBIOMEDICAL CO., LTD.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/NEXTBIOMEDICAL CO., LTD.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":130,"url":"https://media.zenfs.com/en/prnewswire.com/588b6387042ffd2e0fc53f51bf933efa"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/uo0IF7zsytSwGUYjW3vUCA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIyOTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/588b6387042ffd2e0fc53f51bf933efa","width":400,"height":130}},"href":"https://mma.prnewswire.com/media/2598519/NEXTBIOMEDICAL_Logo.html","href...