CUVIS-spine Advances to Multicenter Trials as Innovative Medical Technology
Date : 2026-03-27
CUREXO Inc. (CEO: Jaejun Lee), a medical robotics company, announced on March 27 that its spinal surgery robotic system, CUVIS-spine, has officially entered multicenter clinical trials under the Innovative Medical Technology designation.
The Innovative Medical Technology program is designed to support the early adoption of new medical technologies by allowing their use in clinical settings for a limited period while verifying safety and efficacy. Technologies validated through this process may subsequently qualify for institutional adoption, including reimbursement under the national health insurance system.
For this clinical study, CUREXO has completed Institutional Review Board (IRB) submissions across multiple major hospitals, including Yonsei University Severance Hospital (Sinchon), Pusan National University Yangsan Hospital, Chung-Ang University Hospital, Kangnam Sacred Heart Hospital, and Yongin Severance Hospital. All participating institutions are currently undergoing review.
The company aims to complete clinical cases within the year and plans to pursue a step-by-step strategy toward broader adoption, including national health insurance reimbursement, following the completion of the multicenter trials.
Notably, Professor Dong-Wook Sohn's research team at Pusan National University Yangsan Hospital, a key participating institution, was recognized for its academic excellence in the January 2026 issue of the Journal of Korean Neurosurgical Society (JKNS), where its study was selected as one of the "Most Influential Spine Research (2023–2024)." The participation of this highly regarded research team is expected to further enhance the credibility of the upcoming clinical outcomes.
CUVIS-spine is a next-generation robotic system that supports precise screw placement and surgical planning in spinal procedures, contributing to improved surgical accuracy and enhanced patient safety.
CUREXO has also recently accelerated its domestic market expansion by signing an exclusive distribution agreement in Korea with CGBIO Co., Ltd., a company specializing in bio-regenerative medicine, for the CUVIS-spine system.
The company has already completed its first domestic installation, generating initial commercial results. Building on this milestone, both companies plan to strengthen system competitiveness through collaboration, incorporating clinical data and real-world feedback.
A company official stated, "The entry of CUVIS-spine into multicenter clinical trials marks a significant milestone in demonstrating both its technological capabilities and clinical effectiveness. Following the completion of the trials within the year, we will actively pursue broader market adoption alongside establishing institutional pathways such as insurance coverage."
List



