Agilis Robotics

Spun off from The University of Hong Kong in 2021, Agilis Robotics has developed what the company describes as one of the world’s smallest fully flexible dual-arm endoscopic surgical robot systems. The Hong Kong-based startup focuses on enabling “incisionless” endoluminal surgery through natural orifices, targeting early-stage cancers in the gastrointestinal tract, urinary system, and other anatomical regions.

Company Overview

Agilis Robotics was co-founded by Professor Ka Wai Kwok from HKU’s Department of Mechanical Engineering, Philip Hui Ka-Ming (CFO and lecturer at HKU SPACE China Business School), Professor Philip Chiu from the Chinese University of Hong Kong’s Faculty of Medicine, and engineering partner Derek Ho. The founding team combined academic expertise in robotics engineering with clinical insights from gastroenterology and surgical practice.

The company maintains its headquarters in Hong Kong, with subsidiary operations in Guangzhou (China) and Boston (USA). This tri-regional presence positions Agilis to pursue regulatory approvals across major markets including NMPA in China and FDA in the United States.

Core Products

Flexible Endoscopic Surgical Robot System

The company’s primary product is a fully flexible endoscopic surgical robot system designed for transoral, transanal, and transurethral procedures. The system features ultra-thin robotic arms with diameters between 2.8mm and 3.5mm, lengths up to 1.8 meters, and 5 degrees of freedom per arm. This miniaturization allows the instruments to navigate through natural body cavities and reach challenging anatomical locations such as the bladder dome.

The system comprises three main components: a primary cart, a compact control console, and single-use flexible robotic arms. A key design principle is direct compatibility with standard clinical endoscopes already in use at hospitals, which reduces capital investment requirements and shortens the learning curve for surgeons.

Technology & Innovation

Agilis Robotics’ technical approach addresses a fundamental limitation in endoluminal surgery: the lack of dexterity available through conventional flexible endoscopes. While traditional endoscopic instruments offer limited maneuverability, the company’s robotic arms provide enhanced articulation that enables en-bloc (single-piece) tissue resection.

The en-bloc approach is clinically significant because removing tumors in one piece—rather than in fragments—improves specimen integrity for pathological analysis and may reduce cancer recurrence rates. This is particularly relevant for procedures such as endoscopic submucosal dissection (ESD) in the GI tract and en-bloc resection of bladder tumors (ERBT).

The system is designed to be AI-powered and cost-effective compared to large laparoscopic surgical robots, requiring no major operating room redesign or substantial upfront equipment investment.

Clinical Development

In December 2024, Agilis Robotics announced the completion of the world’s first robot-assisted en-bloc resection of a bladder tumor using its fully flexible endoscopic surgical robot system. The procedure was performed by a urology team at a leading hospital in Hong Kong as part of an ongoing clinical trial.

Prior to this milestone, the company completed six live animal studies with clinical partners in Hong Kong and Shenzhen, as well as cadaver studies demonstrating the system’s ability to resect tissue in challenging bladder locations. First-in-human trials commenced in 2024, with the company actively preparing regulatory submissions to both the FDA (for bladder indication) and NMPA.

Target clinical applications span multiple specialties:

• Urology: En-bloc resection of bladder tumors (ERBT)
• Gastroenterology: Endoscopic submucosal dissection (ESD) in upper and lower GI tract
• ENT: Throat tumor resection
• Gynecology: Uterine procedures
• Pediatrics: Endoluminal surgery in pediatric patients
• Bariatric surgery: Weight loss procedures in obese patients

Funding & Investment

Agilis Robotics has raised over $17 million across three funding rounds:

The Series A+ round, completed during a challenging funding environment for medical device startups, demonstrated continued investor confidence in the company’s technology and market potential.

Market Positioning

Agilis Robotics operates in the natural orifice transluminal endoscopic surgery (NOTES) and flexible endoscopic surgery segment, a niche within the broader surgical robotics market that has seen limited commercial activity. The company positions its system as a lower-cost alternative to large laparoscopic robots like the da Vinci system, targeting procedures that can be performed entirely through natural body openings without external incisions.

With over 3.5 million new GI cancer cases and approximately 690,000 bladder cancer cases diagnosed globally each year, the company sees substantial addressable market opportunity in early-stage tumor treatment.

Key Milestones

• 2021: Company founded as HKU spin-off
• 2022: Completed Series A funding ($6M)
• 2024 (March): Closed Series A+ round ($10M)
• 2024 (July): Completed cadaver study for ERBT indication
• 2024 (December): World’s first robot-assisted ERBT in clinical trial

Frequently Asked Questions

What makes Agilis Robotics different from da Vinci surgical robots?

While da Vinci systems are designed for laparoscopic surgery requiring external incisions, Agilis Robotics focuses on endoluminal surgery through natural orifices. The company’s instruments are significantly smaller (2.8-3.5mm diameter vs. 8mm+ for laparoscopic instruments) and fully flexible, allowing access through the mouth, urethra, or anus without any external cuts.

Has the Agilis robot received regulatory approval?

As of January 2026, the Agilis Robotics system has not yet received NMPA, FDA, or CE approval. The company is actively preparing regulatory submissions to both FDA and NMPA, with FDA clearance initially targeted for 2025.

Where is Agilis Robotics headquartered?

Agilis Robotics is headquartered in Hong Kong, with subsidiary operations in Guangzhou (China) and Boston (USA).