Agilis Robotics Completes Cadaver Study for a Novel Endoluminal Surgical Robot, Aims at First-in-human (FIH) Trial This Year

The study aimed to assess the robot's ability to assist urologists in performing en-bloc resection of bladder tumours (ERBT), an emerging minimally invasive procedure that only requires access to the bladder via the urethra, without any external incisions. The procedure has been shown to significantly reduce recurrence rates, improving patient outcomes by removing tumors in one piece (i.e. "en-bloc").

Through Agilis Robotics' ultra-thin flexible robotic instruments, the surgeons were able to successfully resect tissue en-bloc in locations within the bladder that are typically challenging when using traditional instruments, such as the bladder dome. These findings lay a solid foundation for the upcoming clinical application of the system.

The company has designed and developed fully flexible robotic instruments for endoluminal surgery with cutting-edge mechanical architecture. Each instrument is highly miniaturized between 2.8 mm to 3.5 mm in diameter and provides 5 degrees of freedom, allowing surgeons to execute complex procedures of tissue resection with great precision and ease inside natural orifices.

Their innovative approach to robotic instruments also targets endoluminal treatment of the gastrointestinal (GI) tract, in addition to the bladder. Utilizing a single robot system, they target effective en-bloc removal in both anatomies via endoscopic submucosal dissection (ESD) and en bloc resection of bladder tumors (ERBT). This unique versatility sets their technology apart from current surgical robots on the market.

Agilis Robotics' compact, intuitive, and versatile endoluminal robotic system is designed to be directly compatible with standard clinical endoscopes, both rigid and flexible, thereby enhancing surgical capabilities with minimal learning curve or disruption to existing clinical workflows.

With more than 3.4 million new GI cancer cases and 610k bladder cancer cases per year globally, Agilis Robotics is strategically positioned to capture the underserved endoluminal surgery market, aiming to allow more patients to receive effective early-stage treatment with reduced procedure time and recurrence rates, redefining a new standard of care in minimally invasive surgery. Combined with a highly competitive price point, the system by Agilis Robotics is a distinctively versatile and cost-effective product.

Agilis Robotics is preparing to conduct a first-in-human (FIH) study to assess the feasibility of the robotic system in a clinical setting. Agilis Robotics aims to first submit its application to the U.S. Food and Drug Administration (FDA) for its bladder indication later this year. Later, the company will also submit its application to China's National Medical Products Administration (NMPA). Agilis Robotics plans to follow this initial clinical application with several others, using its proprietary technology in the upper and lower GI tract, throat, gynecology, and other indications.

Agilis Robotics secures US$10m capital in its latest funding round. For additional information, visit the Company's website at https://www.agilisrobotics.com/
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