Roen

What Roen does

Roen Surgical (주식회사 로엔서지컬, formerly EasyEndo Surgical) is a Daejeon, South Korea-based medical device company founded in 2018 by KAIST Professor Dong-Soo Kwon with eight of his students. The company develops the Zamenix platform, marketed as the world's first AI-enhanced, fully robotic system for flexible ureteroscopy (RIRS) targeting kidney stone removal. Zamenix combines a 2.8mm flexible endoscope with worm-like articulation (270-degree bending, 360-degree rotation), a tele-operation console with radiation shielding, and proprietary AI capabilities including respiratory motion compensation, autonomous path memory/replay, AI-based stone size measurement with safety guidance, and semi-automatic laser-and-basket workflow. The system is compatible with commercial flexible ureteroscopes and lasers, and the broader product ecosystem includes the VitalUro training simulator, Basic/Advanced Zamenix Training Programs, and technical support/maintenance services.

Roen's revenue model rests on capital sales of Zamenix systems to hospitals, supplemented by training services, recurring maintenance contracts (bi-annual preventive maintenance), and licensing/distribution royalties in international markets. The go-to-market is an enterprise field-sales motion centered on Korean tertiary university hospitals (Seoul National University Hospital, Samsung Medical Center, Korea University Anam Hospital, Yeungnam University Medical Center, Busan Adventist Hospital), now expanding to secondary hospitals, primary-care urology clinics (Goldman Urology Network), and international markets via distributor partnerships (PT Hospi Medik Indonesia, Ramathibodi Hospital in Thailand). The company operates a headquarters and production facility at KAIST Munji Campus in Daejeon and a sales/marketing office in Seoul, and is preparing for a KOSDAQ listing in 2027 with Korea Investment & Securities as underwriter.

Name

Roen

Legal name

주식회사 로엔서지컬 (ROEN Surgical Inc.)

Website

https://roensurgical.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

101–250 employees

Short description

Roen Surgical develops Zamenix, an AI-powered robotic system for flexible ureteroscopy (RIRS) used by hospital urology departments to remove kidney stones more precisely, safely, and with reduced surgeon fatigue and radiation exposure.

Ownership category

akta.pro rank

Product category

Surgical Robotics

NAICS

Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Surgical Robotics & Computer-Assisted Surgery Platforms (HLAHADAF)

akta.pro secondary industries

Endourology & Minimally Invasive Urologic Surgery (HLAKAOAF), Endoscopy Systems & Accessories (Scopes, Cameras, Light Sources, Insufflation) (HLAHADAB), Kidney Stone Management & Lithotripsy Devices (HLAHAKAI)

Keywords

• Surgical robotics
• Medical device manufacturing
• Robotic surgery systems
• Urology surgical robots
• Endourology devices

Headquarters

HQ city

Daejeon

HQ country

South Korea

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Zamenix System Sales: Sale of AI-powered kidney stone surgery robot systems to hospitals and medical centers, including flexible endoscopic robot and remote-control console
2. Training and Support Services: Technical support, training services, and maintenance contracts for installed Zamenix systems; preventive maintenance performed every 6 months
3. Licensing Royalties: Technology licensing agreements for international distribution, such as the exclusive distribution agreement with PT Hospi Medik Indonesia for Indonesia market

Go-to-market motion1 record

Distribution channels4 records

Marketing channels7 records

Core offering

Roen Surgical designs, manufactures, and sells the Zamenix AI-powered flexible endoscopic surgical robot system that enables a single surgeon to remotely perform kidney stone removal via retrograde intrarenal surgery (RIRS) using a 2.8mm flexible endoscope, along with the VitalUro surgical training simulator, structured surgeon training programs, and ongoing technical support and maintenance services for installed systems.

Product overview

Roen Surgical offers a platform-based product portfolio anchored by Zamenix™, the world's first AI-powered fully robotic system for flexible ureteroscopy kidney stone surgery. The platform consists of a 2.8mm flexible endoscopic robot and a remote-controlled master console that enables single-surgeon operation. Key AI features include respiratory compensation, stone size guidance, and autonomous path navigation. The ecosystem includes VitalUro for surgical training simulation, comprehensive training programs (Basic and Advanced levels), and technical support services. The company also maintains earlier-generation technology (easyUretero) in its portfolio.

Differentiator

Problem solved

Functional benefit

Brands

• Zamenix: World's first AI-based fully robotic platform for flexible ureteroscopy, designed for kidney stone surgery. Features AI-based respiratory compensation, stone size guidance, and path recording functions.
• VitalUro

Products and services

• Zamenix World's first AI-enhanced, fully robotic platform for flexible ureteroscopy (RIRS) that lets a single surgeon remotely control a 2.8mm flexible endoscope to fragment and extract kidney stones using AI respiratory synchronization, autonomous path navigation, and stone size safety guidance. Sold to urology departments of university hospitals, tertiary medical centers, and large urology clinics.
• VitalUro Realistic medical training simulator for kidney stone removal using an artificial kidney with lifelike texture, featuring respiration synchronization, dynamic fluid flow, adjustable difficulty, and an integrated irrigation system to train surgeons on the Zamenix platform.
• easyUretero Earlier-generation robotic system for flexible ureteroscopy and laser lithotripsy that served as the technological predecessor to the Zamenix platform and was the subject of multiple preclinical and clinical studies including porcine models.
• Zamenix Training Program Structured surgical robot training service for Zamenix operators covering Basic and Advanced levels, including online courses, hands-on training, VitalUro simulator practice, and wet-lab animal trials tailored to individual surgeon skill levels.
• Zamenix Technical Support Service Ongoing technical support service for installed Zamenix systems, offering a 4-hour initial response, 48-hour repair delivery, bi-annual preventive maintenance visits, and real-time remote monitoring to prevent issues and optimize surgical operations.

Quantifiable outcome

• 93.5% stone-free rate in pivotal clinical trial of 46 Korean adult patients (residual fragments <4mm at 1-month CT scan)
• +4 more outcomes

Named customers10 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature6 records

Partnerships

13 partnerships are on record, tiered core and major.

• Samsung Medical CentercoreStrategic or Co-development Partner · 28 May 2026Samsung Medical Center selected as lead organization for Ministry of Health and Welfare's AI-based surgical robot innovation project with ~10 billion won government funding over 5 years. Collaborating with Rainbow Robotics, E-ROBE, and Roen Surgical (AURORA lab) along with research institutions including Samsung Advanced Institute for Health Sciences and Technology, DGIST, and Tomorrow Robotics.
• Rainbow RoboticsmajorTechnology or Integration · 28 May 2026Collaborating company in AURORA lab for AI surgical robot development under Ministry of Health and Welfare project led by Samsung Medical Center
• E-ROBEmajorTechnology or Integration · 28 May 2026Collaborating company in AURORA lab for AI surgical robot development under Ministry of Health and Welfare project led by Samsung Medical Center
• Mandaya Royal Hospital (Indonesia)coreStrategic or Co-development Partner · 13 January 2026Sales contract and strategic MOU for clinical, research, educational, and marketing cooperation. Mandaya Royal Hospital in Jakarta designated as official training center for Zamenix. Company to provide local medical staff education and technical support. Chosen for Indonesia's population of 286 million and 5% annual economic growth rate.
• Johns Hopkins University and University of MichiganmajorStrategic or Co-development Partner · 1 July 2025US hospitals with which joint clinical trials for FDA approval process are under planning
• Ramathibodi Hospital (Thailand)coreStrategic or Co-development Partner · 22 January 2025First live overseas demonstration of Zamenix conducted at Ramathibodi Hospital in Bangkok during RIRS 2025 symposium. Professor Chinnakhet Ketsuwan led the demonstration with technical support from Seoul National University Hospital. Six Thai patients received treatment showcasing capability in challenging cases including narrow ureters and hard-to-reach stones.
• PT Hospi Medik Indonesia (Surgika Alkesindo Group)coreChannel Partner/ Reseller/ Distributor · 7 January 2025Exclusive 3-year distribution agreement for Zamenix throughout Indonesia. PT Hospi Medik Indonesia is a subsidiary of Surgika Alkesindo, the largest medical device distribution company in Indonesia specializing in surgical equipment, medical imaging, and radiation devices. Full-scale exports planned after completing licensing registration with Indonesian FDA in first half of 2025.
• Gachon University Gil HospitalmajorStrategic or Co-development Partner · 10 December 2024MOU for mutual cooperation in new drug development and joint development of medical devices. Partnership with Gachon Biomedical Convergence Research Institute for joint research, clinical trials, animal experiments, and exchange of information and publications.
• Yonsei Medical CentermajorStrategic or Co-development Partner · 1 January 2024MOU for Surgical Robot Training Center signed to expand AI and robotic surgery education. Yonsei Medical Center joins network of training sites for Zamenix operators.
• Yangsan Busan National University HospitalmajorStrategic or Co-development Partner · 1 January 2024Selected for Korea Robot Industry Advancement Institute's Service Robot Demonstration Project 2024. MOU for research exchange and cooperation. Hospital working with Roensergical (likely Roen Surgical) on surgical robotics development.
• Seoul National University HospitalcoreStrategic or Co-development Partner · 1 January 2022MOU for medical device R&D and clinical trial collaboration. SNUH conducted pivotal 46-patient clinical trial in 2022 demonstrating 93.5% stone-free rate. Professor Cho Sung-yong's team leads ongoing clinical research including laser protocol development and preclinical studies. SNUH Robot Training Center established with Zamenix installation.
• Korean Urological Association (KUA)majorStrategic or Co-development Partner · 1 January 2021MOU signed for cooperation and clinical validation support for Zamenix technology in urology applications
• Hyundai Asan Medical CentermajorStrategic or Co-development Partner · 1 January 2021MOU signed for clinical trial and research collaboration in medical robotics

Scale indicators12 records

Recent moves11 records

Expansion highlights8 records

Broad incumbents

• Stryker (MAKO Surgical): MAKO Surgical (acquired by Stryker) pioneered robotic-assisted orthopedic surgery. While primarily orthopedic-focused, Stryker represents a strategic incumbent that could expand into urological robotics and competes broadly for hospital capital budgets alongside Zamenix installations.
• Intuitive Surgical: Global leader in surgical robotics with the Da Vinci platform. Roen identifies Intuitive as one of only four companies globally with regulatory approval for robotic endoscopic systems; Intuitive's scale, hospital relationships, and R&D resources make it the dominant incumbent Roen must differentiate against, particularly in urology.
• Medtronic (Hugo RAS): Medtronic's Hugo robotic-assisted surgery platform is a multi-port laparoscopic system expanding into urological procedures. As a global medtech incumbent with deep hospital relationships and capital resources, it represents a direct competitor in the surgical robotics category where Roen's Zamenix competes.
• Johnson & Johnson (MONARCH/Auris Health): Through the Auris Health acquisition, J&J developed the MONARCH platform for robotic bronchoscopy and is expanding into urological applications. Named by Roen as one of only four companies with robotic endoscopic regulatory approval, representing a well-capitalized competitor in the same flexible endoscopic robotics category.

Emerging players

• EndoQuest Robotics: US-based developer of a flexible endoscopic surgical robot for endoluminal procedures. Most direct technology analog to Roen's Zamenix in terms of flexible intraluminal robotic surgery focus, though EndoQuest is at an earlier commercialization stage and targets different anatomical applications.
• Asensus Surgical: Developer of the Senhance surgical robot system, positioned as a digital laparoscopic alternative. Asensus represents a similar-stage emerging player in surgical robotics pursuing multi-specialty adoption including urology, with comparable scale and pre-profitability profile.
• CMR Surgical: UK-based developer of the Versius surgical robotic system for laparoscopic procedures. CMR is a similar-stage emerging surgical robotics company pursuing international expansion across multiple procedure types, including urology, with comparable regulatory and commercialization challenges to Roen.
• Avatera Medical: European developer of the avatera system for minimally invasive robotic surgery. A peer-stage emerging surgical robotics company with similar regulatory and commercialization profile, competing for hospital adoption in urological and gynecological procedures.

Others

• Olympus (Flexible Ureteroscopes): Global leader in flexible endoscopes and ureteroscopes used in kidney stone procedures. Olympus's flexible ureteroscopes are explicitly compatible with Zamenix, making it a complementary enabling partner; however, Olympus is also developing its own digital surgery and robotic surgery capabilities, creating a long-term competitor risk.

Regional players

• Richard Wolf (ENDOCAM Logic): Germany-based medical technology company with a strong endoscopic surgery portfolio including flexible ureteroscopes and laser lithotripsy systems. Represents a regional incumbent in endourology whose compatible flexible ureteroscopes and laser systems integrate with Zamenix, positioning it as both a potential partner and indirect competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/roensurgical
• YouTubeyoutube.com/@roensurgical
• LinkedInlinkedin.com/company/roen-surgical

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds1 record

Investors1 record

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Roen