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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 the space.
Much has been said about robotic and navigation 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 the humans 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. New companies are developing technology to work with diverse implants and instruments 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 companies in this space preparing for market launch. Here we highlight three of those companies and their very different intraoperative technologies.
Galen Robotics
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 is “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. The company’s predicate is the da Vinci Surgical System.
Team: Galen Robotics is a spinoff from 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. The company’s Vice President of Product Engineering came from Think Surgical.
Leadership Commentary: 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.
HoloSurgical
Technology: ARAI, an augmented reality (AR) and artificial intelligence (AI)-based surgical 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: 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.
TrackX
Technology: TrackX Snap and the company’s proprietary software utilize only 1-2 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, this is just three of the players in the computer-assisted surgery orthopedic space. We’ve tracked more than 70+ players, and we expect more will be founded in the next few years.
Image courtesy of HoloSurgical.
