The proliferation of computer-assisted technology companies entering the joint replacement, spine and trauma markets indicates to us that industry believes that there's room for product introduction and adoption in robotic- and navigation-based surgery.
Much has been said about robotic and surgical tracking technology in development or launched by large and medium-sized orthopedic companies—DePuy Synthes, Globus Medical, Medtronic, NuVasive, Smith & Nephew, Stryker, Wright Medical, Zimmer Biomet; the list goes on. All of these players have acquired technology and personnel to advance that technology instead of building from scratch, internally.
Now we’ve reached a phase in the computer-assisted technology narrative in which companies are heading back to the market to acquire new expertise to integrate into their systems. This was demonstrated in March by Exactech’s purchase of XpandOrtho and Smith & Nephew’s acquisition of Brainlab's orthopedic business. We expect these types of partnerships to continue, whether through outright purchases or license agreements. Numerous new technology companies lack implants and expect the trend of partnering or being acquired by a device company to continue, too.
While attending AAOS and the Canaccord Genuity Musculoskeletal Conference, we spoke with and heard from small and pre-revenue companies in this space. Here we highlight four of them—three new, one established but newly restructured—and their very different intraoperative technologies. We chose these four companies to demonstrate the varying physical size and price range of computer-assisted technology in development and on the market.
Technology: Robot that is instrument-agnostic and reduces hand tremors to improve tool stabilization, guidance and weight cancellation in minimally invasive surgery. The company is building a general robot with plans to include software for diverse medical indications, starting with neuro and ENT and then expanding to spine, orthopedics and tissue reconstruction.
Equipment: Robotic system "no bigger than a person," offers 60+ degrees of rotation; expected to cost $200,000 to $250,000 per unit with disposable instrument kits averaging $500 each.
Regulatory Status: FDA pre-submission meeting expected in 2Q19; FDA 510(k) clearance expected in 2H20; predicate is the da Vinci Surgical System.
Team: Galen Robotics is a spinoff from the Johns Hopkins University robotics lab, headed by Russell Taylor, Ph.D., a founding figure in medical robotics. Galen’s industry advisors include Maurice Ferre, M.D., Co-Founder and CEO of MAKO Surgical and Gary Henley, former CEO of Wright Medical and Orthofix and President of Smith & Nephew’s Endoscopy division; Vice President of Product Engineering came from Think Surgical.
Leadership Commentary: Galen Robotics' President and CEO Bruce Lichorowic has compared the technology to power steering in a car—the surgeon controls the instrument, but the robot assists by sensing the surgeon’s motion.
The company has half of its planned $25 million in Series A funding committed, 42 patents filed and feedback from 100+ surgeons who have used the robot.
Technology: ARAI, an augmented reality (AR) and artificial intelligence (AI)-based system, was built to overcome the visualization limitations and lack of intelligent guidance offered by current robotic and computer-assisted surgery systems. ARAI provides a 3D real-time matched image overlay displayed directly onto the operative field. The system offers visualization of all internal anatomy without soft tissue exposure, automatic anatomy identification and autonomous surgical planning and computer guidance throughout surgery. Additionally, ARAI’s artificial-intelligence based algorithms allow the technology to adapt to surgeons using big data-based guidance.
ARAI is compatible with any intraoperative CT scanner and surgical instruments from different manufacturers.
Equipment: Includes a surgical workstation with a screen size of 14.5” and a footprint of 23.6” x 23.6”; technician workstation with multiple screen sizes and a footprint of 23.6” x 23.6”; augmented reality headset; navigation tracking.
Regulatory Status: Seeks FDA 510(k) clearance for spine and cranial indications in 2H19.
Team: CEO and CTO associated with the University of Illinois in Chicago; CEO is serial entrepreneur and Chief of Spine Surgery; CTO is a pioneer in virtual, mixed and augmented reality technology.
Leadership Commentary: CEO Kris Siemionow, M.D., Ph.D., compared current robotic and navigation technology on the market to using a map to get from point A to point B in contrast to HoloSurgical’s ARAI, which is like a driverless car.
While the company is currently focused on spine—placing pedicle screws for fusion—and has completed two in-human procedures, the company sees ARAI as a platform technology. HoloSurgical expects to expand the technology to orthopedics, including the direct anterior approach to hip replacement, and integrate it into robotic systems.
Technology: Knee and hip replacement handheld disposable navigation devices that provide real-time data for precise positioning of implant components. The devices have been used in more than 100,000 cases, with more than 95% of those in the knee. The technology doesn’t change surgeon workflow.
Equipment: Handheld disposable device that averages $750 per surgery in the U.S.
Regulatory Status: HipAlign, KneeAlign and UniAlign all FDA 510(k) cleared.
Team: Restructured internally from January 2017 to mid-2018; CEO, CFO and Vice President of Marketing came from Blue Belt Technologies. Since early 2017, OrthAlign has more than doubled its workforce—now 75+ employees—bringing in software and electrical engineers.
Leadership Commentary: Company is now positioned to launch new products and build revenue, according to CEO Eric B. Timko.
The company is targeting ASCs in the U.S., as well as emerging markets like India and South Africa where robotic technology is not affordable.
Aesculap, DePuy Synthes, DJO, Exactech, Smith & Nephew, Stryker and Zimmer Biomet are among the companies that have a distribution relationship with OrthAlign. Sold in 25+ countries.
OrthAlign expects a full launch of HipAlign in 2019. Future advancements include a reusable device and gap/ligament balancing.
OrthAlign achieved revenue of $22.2 million in 2018 and announced projected revenue of $30.2 million in 2019.
Technology: TrackX Snap and the company’s proprietary software utilize only one to two low-dose scouting x-rays to emulate live fluoroscopy and track surgical instruments in real-time. The technology allows surgeons to maintain their workflow and O.R. setup, while reducing radiation exposure for the patient, surgeon and O.R. team.
Initial cases found 83% radiation reduction and 81% time savings with use of TrackX.
Equipment: Snap is compatible with any instrument. Snaps cost about $50, a price that could be lowered.
Regulatory Status: Received FDA 510(k) clearance in 1Q18 for a general indication so that it can be used in any area of the body, with any C-arm or computer-assisted tracking system.
Team: Leadership has experience at FDA, LessRay (sold to NuVasive), Medtronic and SpineWave, with a surgeon CEO.
Leadership Commentary: TrackX started its alpha launch in 1Q19.
The technology and its price point are uniquely suited for the ambulatory surgical center setting, said CEO Robert Isaacs, M.D. The company’s initial focus is on minimally invasive spine surgery and orthopedic trauma, with plans to expand to hip.
Again, these are just four of the players in this segment. We've tracked more than 70+ companies playing in the robotics/computer assisted surgery space. You can find the full list via the Device Company Directory at ORTHOWORLD.com.
Carolyn LaWell is ORTHOWORLD’s Chief Content Officer.