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CUVIS-spine Advances to Multicenter Trials as Innovative Medical Technology

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."

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CUVIS-joint Surgical Robot Secures U.S. FDA Approval

CUVIS-joint Surgical Robot Secures U.S. FDA Approval, Targeting $14.4 Billion North American Market CUREXO Inc. (KOSDAQ: 060280), a medical robotics company, announced on March 26 that its robotic system for joint replacement surgery, CUVIS-joint, has received approval from the U.S. Food and Drug Administration (FDA). The company obtained FDA clearance approximately nine months after submitting its application in July 2025, marking a significant milestone in its entry into the United States, the world's largest medical device market. The North American joint replacement market is valued at approximately USD 14.4 billion (KRW 19 trillion), accounting for over 60% of the global market. In the United States alone, more than 4.3 million joint replacement procedures are performed annually across over 1,400 hospitals, providing a stable demand base and accelerating the adoption of surgical robotics. CUVIS-joint is a fully automated robotic system designed to assist surgeons in precisely cutting bone and accurately implanting prosthetic joints based on preoperative imaging data. Built on an open-platform architecture, the system is compatible with a wide range of implants and enables patient-specific procedures, improving both surgical accuracy and efficiency. Since receiving approval from Korea's Ministry of Food and Drug Safety (MFDS) in June 2020, CUVIS-joint has continued to demonstrate its technological competitiveness in major global markets, securing regulatory approvals from Japan's PMDA in 2025 and the European CE MDR certification in 2026. Currently, CUVIS-joint is in use across more than nine countries, including India, Indonesia, Taiwan, Japan, Brazil, and Vietnam, with cumulative procedures reaching approximately 43,000 cases. Building on this global track record, the company expects to strengthen its competitiveness in the U.S. surgical robotics market, which is led by major global ps. A company official stated, "This FDA approval is particularly meaningful as it marks our entry into the United States, the world's largest medical device market. Leveraging our extensive global references and fully automated technology, we will focus on translating this milestone into tangible revenue growth in the U.S. market."

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Showing a Leading Lineup of Three Surgical Robots at KIMES 2026

SEOUL, South Korea, March 23, 2026 – CUREXO (CEO Jae-jun Lee), a leading medical robotics specialist, announced its successful participation in the 41st Korea International Medical & Hospital Equipment Show (KIMES 2026), held at COEX in Seoul through March 22.At this year's exhibition, CUREXO introduced its latest medical robotics portfolio, covering the entire patient care continuum from surgical intervention to recovery. Key highlights included:CUVIS-joint: Featured the upgraded "Knee 2.0" version for total knee arthroplasty and new Total Hip Arthroplasty (THA) capabilities.CUVIS-spine: Demonstrated its new endoscopic navigation functionality for enhanced surgical precision.Morning Walk: Showcased a newly developed gait propulsion training system for advanced lower-limb rehabilitation.Innovative Solutions for Precision SurgeryCUVIS-joint is an AI-driven surgical system that enhances accuracy through robotic control and provides patient-specific joint replacement via its open-platform compatibility. With extensive clinical data from both domestic and international markets, the system has solidified its competitive edge through proven safety and operational efficiency.CUVIS-spine is designed to provide precise guidance for pedicle screw placement during spinal surgery, minimizing errors and reducing the physical burden on surgical teams. It is gaining traction in the field for its high accuracy, particularly in minimally invasive surgery (MIS) environments.Advancing Rehabilitation TechnologyFor patients with lower-limb paralysis or gait impairments, MorningWalk—an end-effector type gait rehabilitation robot—provides repetitive and precise training to facilitate faster recovery."Through KIMES 2026, we successfully demonstrated CUREXO's technological leadership in both surgical and rehabilitative robotics to medical professionals and industry leaders," said a CUREXO representative. "By leveraging our end-to-end portfolio that spans from orthopedic surgery to rehab, we will continue to strengthen our position as Korea's representative medical robotics company."

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Morning Walk has successfully achieved CE Marking under the European Medical Device Regulation

Curexo's gait rehabilitation robot Morning Walk has obtained CE Marking under the European Medical Device Regulation (MDR). Compared to the previous Medical Device Directive (MDD), the MDR significantly strengthens safety and quality requirements. With this certification, Curexo has secured a foundation for entering the European rehabilitation robotics market. Based on this milestone, the company plans to actively expand into the global rehabilitation robotics market, including Europe, the Middle East, and Africa.

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Participation in AAOS 2026, the largest orthopedic conference in the United States

Curexo participated in AAOS 2026, the largest orthopedic conference in North America, held in New Orleans, United States.At the event, Curexo showcased its robotic systems for joint replacement surgery, CUVIS-joint and CUVIS-joint THA, designed for hip arthroplasty. The company also introduced its AI-powered robotic surgery platform featuring AI-bone Segmentation, an AI-based automatic bone segmentation technology. Through the exhibition, Curexo expanded engagement with North American surgeons and industry professionals, further strengthening the foundation for its global market expansion.

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Participation in ITC (International Trauma Congress) 2026, Dubai

Curexo participated in the ITC (International Trauma Congress) held in Dubai from the 13th to the 15th. At the exhibition, Curexo introduced its robotic system for joint replacement surgery, CUVIS-joint, together with its Egyptian partner Orthohouse, aiming to expand its sales network across the Middle East and North Africa (MENA) market. Curexo continues to pursue market expansion through a global partnership–based strategy, engaging with local medical professionals and distributors in the region.

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Participates in WHX Dubai 2026, Accelerates Middle East Med-Robotics Expansion

- Showcases CUVIS-joint Surgical Robot and Morning Walk Rehabilitation Robot, Expands Middle East Network Medical robotics specialist Curexo (060280) announced on the 13th that it successfully participated in WHX Dubai 2026, the world's largest medical device exhibition, held from the 9th to the 12th in Dubai, UAE.Visitors listen to an explanation of the Morning Walk gait rehabilitation robot at the Curexo booth during WHX Dubai 2026. [Photo courtesy of Curexo]  WHX Dubai 2026 (World Health Expo Dubai) is a leading global healthcare exhibition representing the Middle East region, attracting medical device companies, healthcare professionals, and industry stakeholders from around the world. At the exhibition, Curexo showcased its flagship products: the CUVIS-joint robotic system for joint replacement surgery and the Morning Walk gait rehabilitation robot. During the exhibition, the company's booth received visits from medical device distributors and healthcare institution representatives across the Middle East and Africa. Based on live demonstrations, discussions were held regarding potential equipment adoption and partnership opportunities. Through these meetings, the company confirmed the potential for expanding its local partnership network in the Middle East. In particular, Curexo shared its global business roadmap, including its goal of obtaining CE MDR certification in Europe this year, further strengthening partner confidence. CE MDR certification represents enhanced safety and quality standards required not only in Europe but also in key overseas markets such as the Middle East. Securing the certification is expected to serve as a critical turning point for expanding global sales. A Curexo official stated, "The Middle East is a strategic market where government-led healthcare investment and demand for advanced medical services are rapidly increasing. Building on this exhibition, we will accelerate our expansion into the Middle East medical robotics market and further drive overseas revenue growth."

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Indian Subsidiary Secures Medical Device Import License, Expands Local Supply and Service

– Localization of Core Parts and Consumables Supply Chain … Establishment of Local Supply and After-Sales Service SystemCurexo Co., Ltd., a medical robotics company led by CEO Lee Jae-jun, announced on the 13th that its Indian subsidiary has obtained a Medical Device Import License (MD-15) from the Central Drugs Standard Control Organization (CDSCO) for its robotic joint surgery system, CUVIS-joint."CUVIS-joint" (Photo courtesy of Curexo) This approval is a mandatory requirement for the importation of medical devices into India and is significant in that it enables the local subsidiary to directly supply the robotic system, as well as related consumables and core components. With the acquisition of the license, Curexo has established a system under which its Indian subsidiary can directly import and manage consumables and key components, for which demand is increasing in line with the growing number of surgical procedures. This is expected to shorten delivery lead times for consumables in India, enhance inventory responsiveness, and ultimately improve the operational stability and convenience of robotic surgery programs at medical institutions. In addition, the local subsidiary will serve as a service hub, providing equipment maintenance and technical support to distributors and healthcare institutions. The company stated that establishing a localized response system that integrates parts supply and technical support will help enhance equipment uptime and customer satisfaction, thereby laying the groundwork for future revenue growth. A Curexo official commented that the acquisition of the import license is meaningful in that it provides a stable foundation for the Indian subsidiary to carry out local supply and service functions, adding that the company will continue to strengthen its local capabilities to enhance business stability in the Indian market.

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CUVIS-Joint THA Achieves Clinical Success in Hip Replacement Surgery in Korea

- Bumin Hospital President Dr. Yong-Chan Ha Performs Korea's First Successful Hip Replacement Using a Domestic Medical Robot - Indication Expanded from Knee to Hip, Demonstrating an Expandable Surgical Platform CUREXO, a medical robotics company led by CEO Jae-Jun Lee, announced on the 10th that it has successfully completed a total hip arthroplasty (THA) using CUVIS-Joint THA, marking the first successful clinical hip replacement performed by a Korean medical robotics company. The surgery was performed at Seoul Bumin Hospital by Dr. Yong-Chan Ha, President of the hospital and a nationally and internationally recognized authority in hip surgery. This procedure is particularly significant as it represents the first clinical success by a domestic medical robotics company for the THA indication using CUVIS-Joint."Dr. Yong-Chan Ha of Seoul Bumin Hospital is performing hip replacement surgery using Curexo's CUVIS-Joint THA." CUVIS-Joint THA establishes a three-dimensional preoperative surgical plan based on the patient's anatomical structure and enables highly precise bone resection through robotic assistance. This approach minimizes key variables in hip replacement surgery—such as implant positioning errors and leg length discrepancies—thereby maximizing surgical accuracy and consistency. CUREXO has already led the commercialization of domestically developed orthopedic surgical robots through CUVIS-Joint for knee replacement procedures. With this successful hip replacement surgery, the company has expanded its application from the knee to the hip. This achievement demonstrates that CUVIS-Joint is an expandable surgical platform capable of supporting multiple joint replacement procedures within a single robotic system. Dr. Ha stated, "This clinical case is highly meaningful in that it proves, through real-world practice, that Korean-developed surgical robots are capable of performing complex hip surgeries with a high level of precision. As surgical data continues to accumulate, CUVIS-Joint has the potential to drive transformative changes across the field of orthopedic surgery." A CUREXO representative added, "CUVIS-Joint THA is a solution designed to maximize precision in complex hip replacement procedures. Having demonstrated our robotic capabilities in both knee and hip surgeries, we will continue striving to become a global leader in the orthopedic surgical robotics market."

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Expands Global Footprint as CUVIS-Spine Receives COFEPRIS Approval in Mexico

CUREXO's spine surgery robot system, CUVIS-Spine, has received medical device registration approval from COFEPRIS, Mexico's health regulatory authority. CUVIS-Spine is a surgical robot system designed to accurately guide and fix pedicle screws, and has previously obtained regulatory approvals from the U.S. FDA and Korea's Ministry of Food and Drug Safety (MFDS). CUREXO will continue to strengthen its competitiveness and expand its presence in the global spine surgery robot market.