NextBioMedical Receives IDE Approval for Pivotal Trial of Nexsphere-F Genicular Artery Embolization Device

January 15, 2025—NextBioMedical Co., Ltd., which is based in South Korea, announced that it has received investigational device exemption (IDE) approval from the FDA for its RESORB clinical trial of the company’s Nexsphere-F.

According to the company, the RESORB trial is being conducted to achieve market approval for Nexsphere-F for genicular artery embolization (GAE) to treat osteoarthritis-related symptoms. The device is a resorbable embolic microsphere intended to alleviate pain in patients with knee osteoarthritis via an endovascular embolization procedure.

The company stated that RESORB is a multicenter, randomized, open-label study designed to assess the performance of GAE with Nexsphere-F in alleviating pain and improving mobility in patients with knee osteoarthritis. The trial will enroll patients across leading health care institutions in the United States. NextBioMedical advised it is actively seeking and securing clinical trial sites for the United States pivotal trial.

The national Principal Investigator for RESORB is Ziv J. Haskal, MD, Professor of Interventional Radiology at the University of Virginia in Charlottesville, Virginia.

“Nexsphere-F has already received Conformité Européenne Medical Devices Directive approval for use in arthritis embolization and has proven its superior safety and efficacy in thousands of musculoskeletal embolization patients in Asia and Europe,” commented Dr. Haskal in the company’s press release.