Zamenix Gains Direct Procurement Access to Public Hospitals for the Next Three Years
Roen Surgical announced on December 29 that its AI-based kidney stone surgery robot, 'Zamenix,' has been designated as an innovative product (designation number 2025-410) by the Public Procurement Service.
The Innovative Product Program of the Public Procurement Service is a system that officially recognizes products for their innovation, public value, and technological excellence to enhance public services and drive technological advancement. Once designated as an innovative product, public institutions can introduce the product through direct contracts via the Public Procurement Service's public innovation procurement platform, 'Innovation Market,' for the next three years. Additionally, through the pilot purchase program, the product can be purchased with the budget of the Public Procurement Service, allowing demand institutions to acquire it without incurring separate purchase costs.
For companies, this provides a government-funded testbed in the form of actual purchases, creating a favorable environment for initial validation and expansion into public healthcare settings. Major public medical institutions such as national and public university hospitals, regional hospitals under local governments, veterans hospitals, police hospitals, and military hospitals are expected to be eligible for the pilot purchase program.
Zamenix is a device in which an ultra-miniature endoscope passes through the ureter without incision to remove stones. AI technology is integrated into all key functions, including respiratory compensation, endoscope path replay, and stone size guidance, thereby enhancing surgical precision, improving patient safety, and increasing convenience for medical staff. It was designated as the 17th innovative medical device in 2021.
In 2022, a confirmatory clinical trial was conducted at Seoul National University Hospital and Severance Hospital on 46 patients with stones measuring 5 to 30 mm who required retrograde intrarenal surgery (RIRS). The trial demonstrated an efficacy rate of 93.5% for stone removal and a mild complication rate of 6.5%, confirming both effectiveness and safety.
Kwon Dongsoo, CEO of Roen Surgical, stated, "With Zamenix being designated as an innovative product by the Public Procurement Service, we expect the adoption of this high-value equipment by public hospitals-which previously faced access barriers-to accelerate, helping to reduce regional disparities in healthcare. By participating in the pilot purchase program, we will secure validation data and pursue entry into additional programs such as the Excellent Procurement Product system in the future."
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