Updated to include commentary from Auris chief strategy officer Josh DeFonzo.
Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, said today it won FDA clearance for its Monarch robotic endoscopy platform.
The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in diagnostic and therapeutic bronchoscopic procedures.
Auris touted that the system enables more accurate diagnosis and treatment of small and hard-to-reach nodules in the periphery of the lung.
The Monarch system is a flexible robotic endoscopic platform that uses a controller-like interface which allows the operating physicians to navigate the robotic endoscope through the periphery of the lung.
But the system is more than just a robotics platform, Auris chief strategy office Josh DeFonzo told MassDevice.com in an interview, and features integrated technology including advanced software and advancements gleaned from data science.
And more importantly, DeFonzo said, the system features an updated user interface that improves outdated controls normally associated with endoscopic systems.
“One of the things that really attracted us to endoscopy is that there are some major challenges with endoscopy as it exists today. The endoscope has largely looked the same since the ’50s or ’60s and so first and foremost it requires a lot of skill,” DeFonzo said. “Second, ergonomics. You never change something just because of ergonomics, but skill and the ergonomics go hand in hand. Endoscopy requires a lot of skill, but also you’ve got to be very facile in maneuvering a device – a device that’s anywhere from approximately a meter to, in the case of colonoscopy, three meters long.”
Instead of using an antiquated, one-handed interface that requires the user twist and control controls to maneuver the endoscope, Auris’ system allows for more direct control through a game-like controller, DeFonzo said.
“There are many companies who have tried novel control interfaces for other endoscopic applications, in particular GI endosurgery. I do think we’re thinking about it a little bit more holistically where it’s not just about the tangible physical user interface that the physician holds, but it’s the entire experience,” DeFonzo said. “I’d think we thought about it a little bit more, end to end, than what I’ve seen in other clinical applications. I’m not aware of anybody at this point in time who’s rethinking the interface as dramatically as we have or in a fashion that is materially available at this point in time.”
The Monarch platform has other improvements over traditional endoscopy as well, DeFonzo said, including a telescoping, nested endoscope that allows for easier navigation through S-bends and tortuous anatomy.
While the company was initially focused on the platforms use in treating lung cancer, the Monarch platform was designed to go beyond a single indication.
“The entire platform is designed for expandability. Obviously, our first approach here is endoscopy and our first clinical target is lung cancer, but we do have ambitions to apply this platform to additional clinical applications in the future.”
Auris isn’t ready to discuss what indications it will be looking for in the future yet, but DeFonzo said the company is engaged in clinical studies of the platform for its indications in treating lung cancer, with some trials nearing publication in peer-reviewed journals.
“We anticipate beginning a limited launch of the platform across the United States. We also have a number of clinical studies that are pending publication now,” DeFonzo said. “And we do have plans for pilot studies of the system, which should commence later this year.”
“Technology has advanced significantly since the development of the earliest robotics platforms used in medicine. The Monarch platform is designed to address the limitations of current technology with the introduction of a new era of flexible robotics. With this FDA clearance, we intend to deliver on the promise of improving patient care, starting with earlier and more accurate diagnosis of pulmonary nodules. We envision additional uses for the technology across future endoscopic clinical indications,” CEO Dr. Moll said in a press release.
Last August, Auris stealthily raised a massive $280 million in a Series D round of financing, bringing the total raised by the early-stage company to more than $500 million.
The company also turned heads in April, 2016 when it bought Hansen Medical, which Dr. Moll co-founded, for $80 million.
Founder Dr. Moll has been an important factor in multiple startups in medical devices, and specifically robotics, including market leader Intuitive Surgical, Mako Surgical, acquired in 2013 for $1.7 billion by Stryker(NYSE:SYK) and Restoration Robotics and its Artas hair restoration platform.
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