Auris Surgical Robotics, a California-based startup, has secured FDA approval for a bronchoscope as part of the Auris Robotic Endoscopy System (ARES); it is the company’s first surgical robot cleared for the U.S. market. The current CEO of Auris, Frederick Moll, previously co-founded two other surgical robotics companies: Origin Med Systems and Intuitive Surgical, makers of the da Vinci Surgical Robotics system.
The 510(k) premarket notification for the bronchoscope was spotted by IEEE Spectrum and noted in a recent investigative article that pieced together a portrait of Auris’ ambitions using LinkedIn profiles and recently filed patents. The company’s website describes the business as a “technology company based in silicon valley,” but is otherwise sparse on details, and the company has never revealed the purpose of a $150 million financing round hosted last September.
The FDA approval and other recent patents suggest that Auris is focused on minimally invasive procedures that use robotic tools inserted through the mouth or other natural openings to reduce the number of necessary incisions. The bronchoscope, which is the first medical indication FDA approved for ARES, would be used to view and collect samples from lesions in the lungs.
Though no clinical trials were conducted for ARES in the U.S., IEEE Spectrum located a small clinical trial using human participants in Costa Rica.
“The pilot study we carried out was to test for the first time on humans, a robot designed to perform diagnostic bronchoscopies on patients with lesions in the bronchi or lungs suspicious [sic] of cancer,” José Rafael Rojas Solano, principal investigator of the study, told IEEE Spectrum.
A report by Transparency Market Research (TMR) projects that COPD will be the world’s third leading cause of death by 2020, and the global markets for ear, nose, throat (ENT) and Bronchoscopy devices will continue to grow. North America and Europe account for 60 percent of the market, which Global Industry Analysts estimates will be worth $1.3 billion by 2020.
In addition to co-founding Intuitive Surgical, Moll served as CEO of Hansen Medical, which specializes in intravascular robotic catheter systems. Auris acquired Hansen in an $80 million deal in April, and Moll commented that the acquisition would help Auris advance in the field of flexible robotics.
Though controversy remains whether robotic surgery could achieve superiority over human surgeons in safety or cost efficiency, popularity of the technology has surged. Several startups have launched and large medtechs — such as Medtronic, Stryker, Smith & Nephew and J&J’s Ethicon — have made sizeable investments in the technology. Johnson & Johnson recently launched Verb Surgical, a joint robotics surgery partnership with Verily. Medtronic recently partnered with Mazor Robotics and projects surgical robot revenue by 2019.
Auris has not yet formally introduced the ARES system, nor has it announced a launch date.