Size and complexity are chief factors in the development of orthopedic robotic systems. Startup company Fusion Robotics is taking those considerations to a new dimension with its system meant for non-complex pedicle screw placement.
Fusion Robotics came to our attention when it announced closure of an undisclosed sum of funding in 2019. The company stood out for two reasons. First, its lead investors are well-known names in spine, Alex Lukianov and Kevin Foley, M.D. Lukianov, former CEO of NuVasive, serves as Chairman of the Board for Fusion Robotics, while Dr. Foley is Chief Medical Officer. Second, there is the size of the system.
Fusion Robotics seeks to introduce the world’s first portable spinal robotic navigation offering. It can easily fit within a suitcase for simple travel. The full system comprises five parts, including a laptop, USB localizing camera, O.R. table mounting arms and a four-pound robot. A dedicated system also exists comprising the all-in-one computer, USB localizing camera, mounting arms, four-pound robot and a system cart for storage.
A tiny, 200g camera provides an extremely broad field of view, while a built-in radiosurgery patient fixation mechanism eliminates the need for dynamic referencing and line of sight issues. The robot is small, at just four pounds, with manual rough positioning capabilities and precise robotic targeting. Draping the robotic system is simple, with a tool guide end effector directly integrated into the drape.
The robot is a means to achieve improved efficiencies and economics in surgery in an era wherein the number of surgeons is decreasing, while the number of spinal fusions is increasing.
“Surgeons and hospitals need to be more efficient and be able to provide good outcomes. The stress on surgeons is increasing; they are being asked to do more each year. Our goal is to help reduce stress in the O.R. with a simple, easy to use and effective system,” said President and CEO Brad Clayton, who also has significant spine experience serving in various leadership roles at Medtronic, including Robotics, Midas Rex, Navigation, Spine & Biologics.
The Efficiency Factor
Today’s surgical robots are primarily used to place pedicle screws, often in complex cases, said Clayton. Fusion Robotics’ goal is to deliver a platform that will be used in the simpler surgeries and will increase efficiencies in O.R. set up and procedures.
“The basis of the system is simplicity and reliability with a strong focus on being economical,” Clayton said. “The system is much easier to use than the existing large complex ones, the setup time for staff is perhaps five times faster, and the use by the surgeon is easier and faster.”
Cadaver and usability lab results showed improved speed and a simpler process using the Fusion Robotics System. Six surgeons received 15 minutes of training on planning and use, and within 20 minutes, each was able to plan and place two screws accurately without any assistance or coaching.
The Procedure Factor
Orthopedics and spine are moving toward procedure-specific systems. Investors and providers are choosing to back smaller, less expensive, procedure-specific systems that tackle very particular clinical challenges. Fusion Robotics’ goal is to meet these needs.
“We are focused on the posterior lumbar fusion market of 380,000 procedures in the U.S.,” Clayton said. “The system is targeting the non-complex market, which comprises 60% of the 380,000 procedures, with an economical platform that costs one-fourth of the price of existing systems.”
Aside from the price tag itself, hospitals can see financial benefit in the form of performing more procedures with a device that improves surgical efficiencies. The founders of Fusion Robotics have a vision to improve patient outcomes, no matter the environment, with the use of robotics and localization technologies that utilize 3D and 2D imaging techniques alongside traditional navigation methods.
Ambulatory Surgery Centers (ASCs) in particular are expanding as payors seek less expensive, better outcomes; physicians want more independence and earning potential, and patients look for a better experience with fewer infections and lower prices. Still, ASCs remain an unpenetrated market in robotics, as cost has been a prohibitor in traditional systems. Fusion Robotics is targeting what they estimate is a $33 million ASC market with its more economical solution.
Fusion Robotics Looks Forward
Fusion Robotics is in the process of finalizing their FDA 510(k) application with the expectation of receiving FDA clearance in the summer of 2020.
Focusing on the posterior lumbar fusion market, Fusion Robotics has two main competitors in the Medtronic Mazor X Stealth Edition and the Globus Medical ExcelsiusGPS robotic systems. Of course, the competition is expected to increase over the years. Zimmer Biomet’s ROSA is on the market, and other large spine players like Stryker and DePuy Synthes are investing in this area.
The company thinks that its robotic system will stand out from the others.
“In five years, we believe that the Fusion Robotics system will be the market leader in non-complex spinal fusions and will have made a major impact on patient outcomes and surgeon efficiency,” Clayton said.