(www.forbes.com)–When David C. Paul traveled to Phoenix in 2013, he saw the future of spinal surgery: a robot prototype called the Excelsius GPS. Nicholas Theodore, one of the robot’s inventors, remembers Paul being immediately impressed. “This is going to change everything,” Paul said, according to Theodore. A few months later, Paul bought Theodore’s company, Excelsius Surgical—and the robot with it—for an undisclosed sum.
Since 2014, shares of Globus Medical, have more than doubled. Just since the robot received FDA clearance in August 2017, the stock has climbed 65%.
Excelsius GPS: Globus Robot
The Excelsius GPS is one of only two spine-surgery robots on the market, and Globus, which is based in Audubon, Pennsylvania, says it can help surgeons perform spinal fusions by placing screws more quickly and accurately. At this point, though, there’s little large-scale published data to show that Excelsius, which costs more than $1 million per unit, is any better than a surgeon putting in the screws on his or her own; Johns Hopkins University researchers are preparing studies on accuracy and patient outcomes.
There’s a scramble right now to add robots to operating rooms, and money is flowing in that direction. Recently, Medtronic acquired Mazor Robotics, the publicly traded Israeli creator of the other spine-surgery robot on the market, in a deal valuing the company at about $1.6 billion, a 16% premium to the closing share price the day before the acquisition was announced. “I think everyone’s very excited about robots,” says Dr. Jeffrey Wang, orthopedic surgeon and president of the North American Spine Society. “It sounds kind of sexy, and I think people realize there is a lot of potential there.”
The Visionary : David Paul
Paul got his undergraduate degree in India and came to the U.S. where he earned an engineering master’s degree at Temple University in 1994. He went on to work for Synthes, a Swiss medical device maker owned by billionaire Hansjoerg Wyss, before quitting in 2003 to found Globus.
The next year, Synthes filed a suit accusing Paul, another early Globus employee and Globus of poaching workers and misappropriating trade secrets from Synthes. Paul countersued for libel, among other things. Those suits were settled in 2007, with Globus paying Synthes $13.5 million while not admitting wrongdoing. That didn’t end their fight: Back-and-forth litigation between the two competitors over patents and accusations of employee poaching has continued on for the past 14 years, even after Synthes was acquired by Johnson & Johnson in 2012.
Those disputes haven’t dimmed Wall Street’s view of Globus, which has been particularly profitable. Its adjusted EBITDA margin was 36% in 2017. Most of its mid-cap peers struggle to push their margins over 30%.
“The company has a fast-follower mantra, so they might not invest in building the market in the early stages,” says Kyle Rose, an analyst at Canaccord Genuity. “But they know that their R&D capabilities allow them to quickly identify some of the emerging trends and then capitalize on them with what they view as better products and innovation.”
But…Which are the Real Advantages of Robotic Assisted Spinal Surgery?
Accuracy and Precision
Accurate image-guidance in spinal surgery can be used to identify the exact position and trajectory during a procedure and is one of the most important tools in the surgeon’s armamentarium. Screw misplacement can lead to instability as well as neurological, vascular, and visceral injuries. Misplacement-related complications are reported in1% to 54% of spinal surgeries,18 demonstrating a need for surgeons to improve accuracy and consistency in pedicle screw placement. These high complication rates are the main impetus for developing computerized navigation systems and robotic assisted spinal surgery. Robots can potentially help spine surgeons improve accuracy by positioning a guide tube over a preplanned target and can improve precision by scaling the surgeon’s hand movements and reducing tremor; robots also minimize exposure to radiation. Several retrospective analyses have shown comparable accuracy rates between robotic-assisted and conventional screw insertion techniques.
In theory, robotic systems can improve intraoperative localization, especially in patients with more challenging anatomy, while allowing access through smaller incisions. The development of smaller and smaller robotic manipulators and camera systems that are capable of fitting inside very tight spaces make these capabilities possible. Minimally invasive surgery offers several advantages to the patient: smaller incisions, lower risk of infection, and minimal muscle retraction, which can decrease postoperative pain, opioid use, and the length of hospital stays.
Another major theoretical advantage is that robotic-assisted spinal surgery, especially minimally invasive surgery, may reduce radiation exposure since robotic placement decreases the need for using intraoperative fluoroscopy. Radiation exposure as a health hazard to medical personnel is an ever-increasing concern.
Theoretically, if a robot enables easier access with rapid response and holds an accurate and precise surgical trajectory through a less invasive exposure, surgical time could be decreased. However, additional factors regarding operative time require consideration: additional setup time is needed to mount and register a robot, and planning time is needed for the surgeon to identify the desired trajectory. Current data indicate that the decrease in surgery time due to the performance of the robot is offset by the increased setup and planning time. Most available studies reported no significant time difference between robot-assisted and fluoroscopically guided procedures.
The main disadvantage of robotassisted spinal surgery is its technological complexity relative to fluoroscopically guided surgery, which leads to a large increase in potential sources of surgical error. Some of these technological errors may be difficult for the inexperienced surgeon to recognize; therefore, poor outcomes may occur if the technology is relied upon blindly. A particularly troublesome error that has been documented with robotassisted techniques is poor accuracy between preoperative three-dimensional images and the real-time anatomy of the patient. The source of this error can be poor image quality, inaccurate registration, inaccurate or inadequate patient tracking, or a combination of these factors. In some reports, cases of noticeable inaccuracy were dealt with by simply reprogramming the screw trajectory a few millimeters by eye; in other cases, the screws were removed and repositioned by hand.
- Robotics in Spinal Surgery: The Future is Here.BARROW QUARTERLY • Vol. 26, No. 1 • 2016 (Hector Soriano-Baron, MD Eduardo Martinez-del-Campo, MD Neil R. Crawford, PhD Nicholas Theodore, MD, FAANS, FACS)