Auris Health is now the latest surgical robot company with the go-ahead to enter the U.S. market.
The Redwood City, CA, based company, formerly known as Auris Surgical Robots, said Friday that its robotic system has cleared the FDA’s regulatory bar, allowing the system to be used for diagnosing and treating lung cancer tumors.
The Auris robotic system, called Monarch, is based on endoscopy, which involves inserting tiny cameras and instruments through a small opening in the body, avoiding the need to make large incisions. In clearing the Auris robot, the FDA determined that the surgical system was equivalent to bronchoscopic procedures that use devices inserted through the nose or mouth to allow clinicians to examine a patient’s airways. But Auris says it goes further than conventional endoscopy by using software and robotics that augment what a surgeon can do.
The Auris robot is operated by a hand-held controller. Auris says its robotic system combines traditional endoscopic views with computer-assisted navigation based on 3D models of the patient’s own lung anatomy. This capability gives a clinician a continuous view throughout the entire procedure, Auris says. The company adds that its robotic system can help clinicians diagnose lung cancer more accurately, and also help them treat small and hard-to-reach lung nodules in the periphery of the organ.
Though lung cancer is Auris’ first target, co-founder and CEO Frederic Moll said in a prepared statement that the company envisions applying the technology to other endoscopic procedures in the future. Auris would need to receive a separate FDA clearance for each new use of the device.
Though Auris has kept a low profile for much of its history so far, Moll has deep experience in medical robots. He co-founded surgical robot giant Intuitive Surgical (NYSE: ISRG) in 1995 and was that company’s first CEO. Revenue for Sunnyvale, CA-based Intuitive topped $3.1 billion in 2017 and the company and is by far the leader in surgical robot technology. But a growing number of startups are trying to compete with robots that offer more natural controls for surgeons and less invasive procedures for patients.
Last fall, the FDA cleared the Senhance Surgical Robot System from TransEnterix for colorectal and gynecological surgeries. The Research Triangle Park, NC, company says its system’s handheld controls offer haptic feedback that give surgeons a better sense of touch. The system also has a vision system that tracks the surgeon’s eyes, which avoids the need for another person to operate a camera. Other startups developing surgical robots include Toronto-based Titan Medical (TSX: TMD) and Mazor Robotics, which is based in Israel.
Auris says it has raised more than $500 million in equity financing, the most recent round coming last August when the company raised $280 million. Here’s more on the history of Auris and the startup’s robotic surgical system.
Photo by Auris Health.