AURIS' first system, ARES is FDA cleared
Back in 2013, AURIS seemed to be focusing on ophthalmic procedures, since its foundation in 2007. So we believed... Questions about their real activity beyond cataract surgery emerged almost a year ago already. As of last week, AURIS received a 510(k) on a bronchoscope robot application. This explains their appetite for Hansen. Based on their IP portfolio, they have a special design for the flexible endoscope part. IEEE Spectrum has the story:
"Auris, which describes itself only as a “technology company based in Silicon Valley,” was previously thought to be working on a robotic microsurgical system designed to remove cataracts, and the company has in fact filed several patent applications along those lines.
However, an investigation by IEEE Spectrum suggests that the company has greater ambitions, including, according to current and former employees, “building the next generation of surgical robots… capable of expanding the applicability of robotics to a broad spectrum of medical procedures.”
A close reading of recent patent applications filed by Auris scientists shows that the company is focusing on so-called endolumenal (or endoluminal) surgery. This involves surgeons introducing flexible robots via the body’s natural openings (the mouth in particular), to address conditions of the throat, lungs and gastrointestinal system. IEEE Spectrum can reveal that Auris has already carried out at least one successful human trial of such a robot, outside the United States.
ARES, which is a new way of diagnosing and treating patients, has been undergoing tests. Through the pilot study, ARES has been tested with humans with lesions in the bronchi or with suspicion of lung cancer. In the diagnostic test carried out on 15 patients, the robot was able to navigate the airways without adverse effects. In all the 9 patients diagnosed with cancer, ARES robot was able to obtain biopsy samples from eight patients.
The ARES robot, which Auris has yet to announce publicly, was approved by the FDA as a bronchoscope to view and treat lung conditions. It appears to be quite similar to Medrobotic’s Flex Robotic System, an endolumenal robot, fitted with one of a number of surgical instruments, that goes down the throat. The Flex was cleared by the FDA in 2015.
Auris would not confirm that the ARES, which may have a different brand name when it launches, is the same system described in its patent applications. That paperwork describes a system where “interchangeability of instrument device manipulators allow [the] robotic system to perform different procedures… Any number of procedures that may require a tool or no tool at all can be performed using the flexible endoscope.”
One of Auris’s patent applications mentions tools including lasers, forceps, needles, graspers, and scalpels, potentially enabling a surgeon to do everything from biopsies and gastric repairs to excising tumors. “Once a device is on the market, there is a tendency for surgeons to look for new ways to make use of it,” says Drajeske.
Like the well known da Vinci robot, Auris’s robot would be remotely controlled by a qualified surgeon at a desktop work station. She would operate the robot using 3-D maps generated from a collection of 2-D CT scans, and locate the device with electromagnetic sensors, accelerometers, or even automatic video tracking.
Ariel Waldman, an author, digital anthropologist, and co-founder of Science Hack Day, a global science-based hackathon, is working on the hardware and software interface for Auris. Waldman describes the system as a “new breakthrough surgical robot.”
Although Auris Surgical does not feature in the U.S. government’s database of clinical trials, IEEE Spectrum has discovered that in late 2014, Auris sponsored a small clinical trial of a robotic bronchoscope in a hospital in San Jose, Costa Rica.
According to the principal investigator, Dr. José Rafael Rojas Solano: “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.”
The study found that Auris’s robot was able to navigate the airways of all 15 patients in the trial without adverse effects. Of the nine patients eventually diagnosed with cancer, the robot obtained biopsy material from eight. “This study constitutes the first step of [a] very promising technology in the diagnosis and treatment of lung cancer,” says Solano.
Auris does have some interesting intellectual property of its own. A patent application published late last year describes a 3-D coordination system for surgical robots that includes an internal ‘geo-fence’ to prevent surgeons from accidentally injuring patients from the inside."