Roen Surgical Achieves First Export of AI-Based Kidney Stone Surgery Robot "Zamenix"

Collaboration with Mandaya Royal Hospital in Indonesia
for Clinical Research and Medical Staff Training

Roen Surgical, a surgical robot platform company, has successfully exported its artificial intelligence (AI)-based kidney stone surgery robot, Zamenix.

On the 29th of last month, employees of Roen Surgical are taking photos to celebrate Jamenix's first export to Indonesia. Roen Surgical

Roen Surgical announced on January 13 that it recently supplied Zamenix to Mandaya Royal Hospital Puri, a premium medical institution in Jakarta, Indonesia.

Starting with this export, both parties signed a strategic memorandum of understanding (MOU) for cooperation in clinical research, education, and marketing, and agreed to establish a mid- to long-term collaboration framework, including joint clinical studies and training programs for medical professionals. Under this agreement, Mandaya Hospital will be designated as the official training center for Zamenix, where systematic training programs and real-time technical support will be provided to local medical staff.

The reason Roen Surgical chose Indonesia as its first entry point into the Southeast Asian market is due to the country's massive market size of approximately 286 million people, an annual economic growth rate of around 5%, and a relatively fast medical device approval process, all of which create a favorable environment for market entry.

Prior to the export, Roen Surgical raised awareness of Zamenix in Indonesia through participation in major urological societies such as the Indonesian Urology Education Conference (MCUE) and the Urological Association of Asia (UAA), as well as collaboration with local medical professionals and user training. To date, a total of 23 demonstration clinical trials have been conducted locally, achieving high satisfaction among medical staff in terms of surgical accuracy, ease of operation, and patient safety, with no significant complications reported.

Building on this first export to Indonesia, Roen Surgical plans to further expand clinical adoption by focusing on reference hospitals and key opinion leaders (KOLs) in Indonesia, while also pursuing entry into neighboring countries such as Thailand. In the mid- to long-term, the company aims to accelerate its global market expansion in line with its roadmap for obtaining U.S. Food and Drug Administration (FDA) approval and European CE certification.

Kwon Dongsoo, CEO of Roen Surgical, stated, "After a long period of local demonstration surgeries, we were able to confirm the safety and efficacy of the device, which led to this export. In the new year, we will accelerate our export efforts so that Zamenix’s goal of providing safe and effective treatment for patients and accuracy for medical professionals can be realized throughout Southeast Asia."

Meanwhile, Zamenix is currently undergoing innovative medical technology clinical trials in the urology departments of Samsung Medical Center, Yeungnam University Hospital, Kyungpook National University Hospital, Pusan National University Yangsan Hospital, and Korea University Anam Hospital, involving 232 patients. So far, approximately 90% of the clinical trials have been completed without any serious adverse effects.