Agilis Flexible Endoscopic Surgical Robot

Developed by Hong Kong-based Agilis Robotics, this fully flexible endoscopic surgical robot system represents one of the first commercially-oriented platforms designed specifically for incisionless endoluminal surgery. The system enables surgeons to perform complex tissue resection procedures through natural body openings—including the mouth, urethra, and anus—without any external incisions.

Product Overview

The Agilis Flexible Endoscopic Surgical Robot addresses a significant gap in the surgical robotics market: the lack of robotic assistance for procedures performed entirely within the body’s natural lumens. While laparoscopic surgical robots like the da Vinci system have transformed abdominal surgery, endoluminal procedures through natural orifices have remained largely manual.

The system’s defining feature is its ultra-miniaturized, fully flexible dual-arm design. Unlike rigid laparoscopic instruments that require external ports, Agilis’ robotic arms can navigate through curved anatomical passages and articulate with enhanced dexterity once they reach the target site. This enables en-bloc (single-piece) tumor resection—a technique associated with improved pathological assessment and potentially lower cancer recurrence rates.

Key Features

Validated in first-in-human clinical trials completed in December 2024, Agilis provides fully flexible dual-arm endoluminal access through natural orifices for bladder tumor resection and GI tract dissection without any external incision.

• Ultra-thin Profile: Robotic arm diameter of 2.8-3.5mm allows passage through natural orifices and working channels of standard endoscopes
• Extended Reach: Instrument length up to 1.8 meters enables access to deep anatomical locations including the bladder dome and distal colon
• Full Flexibility: Entirely flexible body design (no rigid segments) navigates curved luminal anatomy
• Dual-Arm Configuration: Two independently controlled robotic arms provide tissue manipulation and dissection capabilities
• 5 Degrees of Freedom: Each arm offers enhanced articulation for precise tissue handling
• Single-Use Instruments: Disposable robotic arms ensure sterility and eliminate reprocessing requirements
• Endoscope Compatibility: Integrates with standard clinical endoscopes already in hospital inventory
• Compact Footprint: Control console and primary cart designed for minimal OR space requirements

Technical Specifications

Used in Hong Kong’s ongoing clinical trials, Agilis deploys 2.8-3.5mm disposable arms up to 1.8m long, integrating with existing hospital endoscopes rather than requiring proprietary imaging hardware.

System Components

The complete system consists of three primary components:

Primary Cart: Houses the robotic drive mechanisms and connects to the patient-side instruments. Designed for compact footprint in the operating environment.

Control Console: Ergonomic surgeon interface providing intuitive manipulation of both robotic arms. The console translates the surgeon’s hand movements into precise instrument articulations at the distal tip.

Disposable Robotic Arms: Single-use flexible instruments that attach to the endoscope working channel. Each procedure uses fresh, sterile instruments, eliminating cross-contamination risk and reprocessing logistics.

Clinical Applications

En-Bloc Resection of Bladder Tumors (ERBT)

The system’s lead indication is robot-assisted ERBT for non-muscle invasive bladder cancer. Traditional transurethral resection of bladder tumors (TURBT) typically removes tumors in fragments using electrocautery loops, which can compromise pathological staging and potentially spread tumor cells. ERBT removes the entire tumor in one piece, improving specimen quality and potentially reducing recurrence.

In December 2024, Agilis Robotics announced completion of the world’s first robot-assisted ERBT using its system, performed at a leading Hong Kong hospital as part of an ongoing clinical trial.

Endoscopic Submucosal Dissection (ESD)

For gastrointestinal applications, the system targets ESD procedures in the esophagus, stomach, and colon. ESD is technically demanding, requiring prolonged endoscope manipulation and precise dissection. Robotic assistance may reduce operator fatigue, improve ergonomics, and enhance dissection precision.

Additional Target Applications

• Throat tumors: Transoral robotic surgery for laryngeal and pharyngeal lesions
• Gynecology: Transcervical procedures in the uterus
• Pediatrics: Endoluminal surgery adapted for smaller pediatric anatomy
• Bariatric procedures: Weight loss interventions in obese patients

Regulatory Status

The company initiated first-in-human clinical trials in 2024 and is preparing regulatory submissions to both FDA and NMPA. If approved, the system would represent one of the first commercially available robotic platforms specifically designed for transurethral bladder tumor resection.

Clinical Evidence

Preclinical Studies: Six live animal studies completed with clinical partners in Hong Kong and Shenzhen, demonstrating system accuracy, safety, and efficacy.

Cadaver Studies: Completed cadaver studies (announced July 2024) demonstrated successful en-bloc tissue resection in challenging bladder locations including the bladder dome and anterior wall.

First-in-Human Trial: Ongoing clinical trial in Hong Kong; world’s first robot-assisted ERBT completed December 2024.

Competitive Positioning

The Agilis system occupies a distinct niche within surgical robotics:

Frequently Asked Questions

What procedures can the Agilis robot perform?

The system is designed for endoluminal procedures performed through natural body openings. Primary targets include bladder tumor resection (through the urethra), ESD in the GI tract (through the mouth or anus), throat tumor surgery (transoral), and gynecological procedures (transcervical).

Does the Agilis robot require external incisions?

No. The system is specifically designed for “incisionless” surgery. All access is through natural body orifices such as the mouth, urethra, or anus.

When will the Agilis robot be commercially available?

As of January 2026, the system remains in clinical trials and has not received regulatory approval in any market. The company is preparing FDA and NMPA submissions.

How does the cost compare to da Vinci robots?

Agilis Robotics positions its system as significantly lower cost than large laparoscopic surgical robots, partly because it integrates with existing hospital endoscopes rather than requiring proprietary imaging systems. Specific pricing has not been disclosed.