SEOUL, South Korea, Jan. 15, 2025 /PRNewswire/ -- NEXTBIOMEDICAL CO., LTD, a KOSDAQ-listed innovative medical device company in South Korea, proudly announced that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its clinical trial, named "RESORB", featuring Nexsphere-F™. Designed to alleviate pain in knee osteoarthritis patients, the fast resorbable embolic microsphere will undergo a multi-center trial in the United States for market approval, marking a significant milestone in its global expansion strategy.
Knee osteoarthritis (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 [1]. While existing treatments, such as 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 multicenter, randomized, open-label study designed to assess how Nexsphere-F™ performs in alleviating pain and improving mobility in patients with knee osteoarthritis. The trial will enroll participants across leading healthcare institutions in the United States, focusing on the novel approach of GAE to treat OA-related symptoms.
Dr. Ziv J Haskal FSIR FAHA FCIRSE, Professor of Interventional Radiology at the University of Virginia and national Principal Investigator for RESORB, stated that "Nexsphere-F™ has already received CE-MDD 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 U.S. Pivotal trial now.
Additionally, CEO Dr. Don Haeng Lee emphasized 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.
About Nexsphere-F™
Nexsphere-F™ is a fast-resorbable microsphere designed for endovascular embolization procedure. Composed of hydrophilic material, it is utilized in arterial embolization in conjunction with a contrast medium. Upon injection through a microcatheter, Nexsphere-F™ microspheres swell to precisely block the target blood vessels, temporarily cutting off the blood supply to the tissues. Over a defined period, the microspheres maintain their embolization effect to facilitate therapeutic outcomes, after which they are completely resorbed by the body. This unique resorption capability ensures biocompatibility, reduces the risk of complications, offering a safe and effective treatment option.
About NEXTBIOMEDICAL
NEXTBIOMEDICAL specializes in the development of innovative therapeutic materials utilizing advanced drug delivery system. The company focuses on the research and development and manufacturing the drug-device combination products tailored to address significant clinical unmet needs.
One of NEXTBIOMEDICAL's flagship innovations is Nexpowder®, an advanced hemostatic powder that has received FDA approval for its effectiveness in achieving rapid and reliable bleeding control. Utilizing proprietary polymer-based technology, Nexpowder® adheres to bleeding surfaces to form a stable, durable barrier, ensuring efficient hemostasis.
Through continuous investment in R&D aimed at high-demand medical challenges, NEXTBIOMEDICAL strives to become a global leader in life-saving solutions, offering groundbreaking treatments that transform patient care and meet the evolving needs of the clinical field.
Reference
[1] Cui, A., Li, H., Wang, D., Zhong, J., Chen, Y., & Lu, H. (2020). Global, regional prevalence, incidence, and risk factors of knee osteoarthritis in population-based studies. Osteoarthritis and Cartilage, 28(11), 1541-1549.
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