Korean Surgical Robot "Zamenix" Achieves First Domestic Completion of Innovative Medical Technology Clinical Trial

Expanding Treatment Options with Enhanced Surgical Precision and Reproducibility
Bridging Skill Gaps and Improving Patient Accessibility

Surgical robot platform company Roen Surgical announced on April 1 that its AI-based kidney stone surgery robot, "Zamenix," has successfully completed a domestic clinical trial for the "robot-assisted flexible ureteroscopic stone removal procedure," marking the first time such an invasive innovative medical technology clinical trial has been completed in Korea.

AI-Based Kidney Stone Surgery Robots Jamenics and Roen Surgical.

Zamenix, designated as the 17th innovative medical device in 2021, is the world's first AI-based kidney stone surgery robot. It removes stones by inserting a 3mm flexible endoscopic robot into the ureter without an incision.

By using a respiratory compensation function, the system tracks moving stones in real time to enhance laser accuracy. Its path playback function shortens surgery time, and the stone size measurement function helps determine the optimal fragmentation and removal method, minimizing damage inside the ureter and kidney. The remote-controlled system also reduces medical staff's exposure to radiation and physical fatigue, thereby increasing surgical focus. Zamenix has so far been introduced at 14 hospitals in Korea and one overseas hospital.

This achievement marks the first case in which a domestically developed surgical robot has entered the regulatory mainstream based on high-quality clinical data. A company representative stated, "Although Korea's medical device industry has demonstrated strong technological capabilities, it has faced limitations in accumulating clinical evidence and linking it to regulatory processes. This case has proven its potential."

This clinical trial used a randomized controlled trial (RCT) to directly compare the safety and efficacy of Zamenix with the conventional standard procedure, flexible ureteroscopic stone removal surgery (RIRS). As a result, Zamenix achieved clinical outcomes equivalent to conventional RIRS, while demonstrating strengths in the robotic platform's unique operational precision and surgical reproducibility. Notably, even among medical staff with relatively less surgical experience, a high stone removal rate was observed, indicating that the robotic platform can potentially reduce the skill gap between physicians.

Unlike conventional RIRS, which is limited in application due to high surgical difficulty and dependence on practitioner expertise, Zamenix leverages robotic technology to increase surgical convenience and safety, broaden treatment options, and present a treatment approach that ensures consistent surgical outcomes, according to the company.

With the completion of this clinical trial, Zamenix will now move from the research phase to actual clinical practice. Hospitals can consider adopting the system regardless of their participation in the innovative medical technology clinical trial, and patients can receive robot-assisted treatment as part of standard care, not just as research subjects.

Roen Surgical plans to expand adoption primarily among leading tertiary hospitals in Korea and to utilize the accumulated clinical data for advancing its AI features and developing next-generation platforms. In addition, the company will use this data as key evidence in global regulatory submissions, such as with the U.S. Food and Drug Administration (FDA) and European CE Mark, to pursue entry into overseas markets.

Dongsoo Kwon, CEO of Roen Surgical, stated, "The completion of this clinical trial is the first domestic case in which a Korean surgical robot has entered the regulatory mainstream based on high-quality comparative clinical data. We will actively utilize the large-scale clinical data we have secured to advance AI-assisted functions and design next-generation platforms, aiming to make Zamenix the new global standard for stone treatment."

This content was produced with the assistance of AI translation services.