Agilis Robotics

The company is developing a surgical robotic system designed to assist surgeons in procedures within natural body orifices, such as the gastrointestinal and urinary tracts, eliminating the need for external incisions. This positions Agilis Robotics to serve the growing endoluminal surgery market, which is driven by an increase in cancer screenings and the detection of early-stage tumors. The system features highly miniaturized and flexible robotic arms, some as small as 2.8 mm in diameter, which can be channeled through conventional endoscopes. This compatibility with existing hospital equipment is a key design feature, intended to reduce the learning curve for surgeons, lower costs, and seamlessly integrate into current clinical workflows. The system, which includes a primary cart, a compact control console, and disposable robotic arms, is priced at less than 20% of conventional robotic surgical systems.

Agilis Robotics has made significant progress in its development and regulatory pathway. The company has completed several live animal studies and a cadaver study to assess the system's ability to perform en-bloc resection of bladder tumors (ERBT). In December 2024, the company announced the successful completion of the world's first robot-assisted ERBT in a human clinical trial. The firm is actively pursuing regulatory clearance from both the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA), with a target for FDA 510(k) clearance by 2025. To support its research, development, and commercialization efforts, Agilis Robotics has secured a total of $17.5M in funding. This includes a $10M Series A+ financing round in March 2024. The company has established a presence in Hong Kong, Guangzhou/Shenzhen, and Boston.