Irvine, Calif.-based startup Ocutrx Vision Technologies LLC unveiled new technology that it said helps surgeons better visualize the operative field during surgical procedures. The OR-Bot Surgery Visualization Theatre combines augmented reality (AR), virtual reality (VR) and both human- and robot-controlled arms to facilitate exacting medical procedures without the need for physicians to look away from the patient.
Ocutrix said the device, which is not yet FDA-cleared, is suited for ophthalmic, ear, nose and throat, vascular, neuro, cardiac and neck, back and spine surgeries. The company plans to officially introduce OR-Bot at the American Society of Cataract and Refractive Surgery meeting, which is being held virtually May 16-17 due to the COVID-19 pandemic.
The all-digital system offers three visualization options: the ORlenz AR headset with 3D viewing and 4K resolution; an autosteroscopic, 3D glasses-free, 3D 8K display monitor positioned in front of the surgeon; or a microscope-like VR viewing station positioned on one of the system’s robotic arms.
Each option provides full 4K resolution to the surgeon’s eyes. The “cobotic” arms allow the surgeon to manipulate them with just a light touch while using voice commands or a foot pedal to engage and position the VR microscope or cameras on the arms.
“The OR-Bot solves a number of space constraints facing surgeons currently by separating the camera from the standard optical microscope … and reducing the size of equipment in the operative field,” said Linda Lam, Ocutrx’s chief medical officer.
The company is also touting the system’s lightweight, ergonomically friendly design, noting the multiple viewing options reduce the pain and strain surgeons often experience when performing intricate procedures.
“With our new cobotic OR-Bot, we’ll be able to offer surgeons several comfortable, lightweight and ergonomically sound solutions to better perform these delicate ophthalmic procedures with faster surgery set-up and turn around,” said Michael Freeman, Ocutrx’s CEO and chief technology officer.
Clinical trials to begin in Q2 2021
The company plans to begin clinical trials at leading ophthalmic hospitals in the second half of 2021 to support regulatory clearances. “We are locking down clinical trial contracts and sites for next year right now, which has been a little hampered by the COVID-19 pandemic,” Freeman told BioWorld. “We expect to conduct joint trials in the U.K., E.U. and the U.S. for FDA and CE approval.”
Founded in 2015, Ocutrx is eyeing a Q1 2021 launch for its first product, the Oculenz AMD headset. The 510(k)-exempt product is intended help people with advanced macular degeneration and low vision navigate their surroundings.
That milestone will be followed with the launch of the Oculenz RMP (remote medical presence) headset – with sensors for temperature, heart rate, blood pressure, pulse oxygenation and visual field tests – in the second quarter of 2021 and the ORlenz Surgery Visualization AR headset in in the third quarter of next year, Freeman said. “The OR-Bot is predicted to be market-ready by later 2021 or early 2022.”
In March, Ocutrx announced successful preliminary results for Orlenz in providing safety for surgeons and operating room technicians using medical lasers. The liquid crystal technology blocked nearly 70% of direct laser hit with reflection and diffusion of intensity of the laser beam.
Ocutrx has been fortunate in not needing to seek venture funding to support its pipeline. According to Freeman, the company is self-funded through a network of retinal and other physicians and surgeons, including vascular surgeons.
As it moves from the developmental to commercial phase of its business, Ocutrx is looking at avenues to support future funding needs, such as the salesforce it plans to develop next year. Freeman said the company is currently interviewing investment bankers and looking at a potential IPO in early 2021.
AR expanding in health care
Use of AR in health care is on the rise, both in and outside the operating room. In December, Augmedics Inc. won FDA clearance for its Xvision Spine system, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation. The Xvision system was the first AR product to be cleared by the agency for guided surgery.
Orthogrid Systems Inc. also got the FDA’s nod for a trauma application for its intraoperable PhantomMSK platform. The application, which is indicated for orthopedic trauma cases, helps surgeons align bone fractures and improve intraoperative efficiencies via artificial intelligence-trained and AR-based decision support and assistance in positioning surgical instruments.
Meanwhile, Mojo Vision Inc. was recently granted an FDA breakthrough designation for its first-of-a-kind true “smart” contact lens, the Mojo Lens, an AR technology that combines a traditional contact lens form factor with an internal, electronic structure that lends it its smart capabilities.