Designated as Innovative Medical Technology in April 2024; First Clinical Trial Successfully Conducted at Severance Hospital

Seoul, Korea – April 11, 2024 – CUREXO, Inc. (CEO: Jae-Jun Lee), a leading medical robotics company, announced that its spine surgical robot, CUVIS-Spine, has been successfully utilized in its first clinical trial at Severance Hospital, Seoul.

CUVIS-spine was designated as an Innovative Medical Technology in April 2024 by the National Evidence-based Healthcare Collaborating Agency (NECA). The designation allows advanced technologies with high potential and innovation to be introduced into clinical practice under certain conditions, facilitating early market entry and evaluation.

The trial at Severance Hospital marks the first clinical case conducted under this designation and represents a critical milestone toward securing national health insurance reimbursement. Additional clinical trials are also planned at Pusan National University Yangsan Hospital, with IRB approval procedures currently underway.

Designed to assist surgeons in accurately guiding and securing pedicle screws, CUVIS-spine integrates advanced 3D imaging devices (O-arm, 3D C-arm) and 2D imaging devices (C-arm). The system offers significant advantages over conventional methods, including:

• Enhanced pedicle screw placement accuracy

• Reduced surgical time

• Shortened patient recovery period

  
  

A CUREXO spokesperson commented:
"Through clinical trials at leading tertiary hospitals, we aim to accelerate the registration of CUVIS-spine as a new medical technology and its inclusion in the national health insurance system. Having obtained approvals from the U.S. FDA, European CE, and Korean MFDS, the safety and efficacy of CUVIS-spine are already validated globally. We are confident that this technology will drive meaningful innovation in spine surgery both in Korea and worldwide."

In addition to CUVIS-spine, CUREXO also offers the CUVIS-joint, an artificial joint surgical robot, and the Morning Walk, a rehabilitation robot. The company continues to strengthen its presence in the global medical robotics market through advanced technology and proven clinical performance.