Surgalign (SRGA) Submits Premarket Notification 510(k) of Its Digital Surgical Guidance System

Surgalign Spine Technologies (NASDAQ: SRGA) a global medical technology company focused on elevating the standard of care through the evolution of digital surgery, today announced it has submitted a premarket notification 510(k) to the U.S. Food & Drug Administration (FDA) for its digital surgical guidance system.1

Surgalign is seeking its first FDA clearance for a hardware and software system that provides intuitive visualization of the patient's internal anatomy and real-time surgical guidance based on intraoperative 3D scans. The first-of-its-kind system combines optical-based guidance technology with augmented reality (AR), “intelligent” spine segmentation and surgical planning utilizing a proprietary artificial intelligence (AI) platform.

Intraoperative 3D digital imaging is transferred to the Surgalign system to create a patient-specific, color-coded “intelligent” model of scanned anatomy that is displayed to the surgeon using augmented reality placed directly over the patient. Machine learning/AI, using a neural network model, has been trained and validated for anatomical segmentation of the lumbar spine based on a large database of pre-analyzed (user analyzed and segmented anatomy) and preprocessed computerized tomography patient scans. The system quickly identifies the patient’s anatomy to help the surgeon for case planning and pedicle screw placement including the location, size, angle, and trajectory in the AR display.

“Having utilized digital technology in my practice for more than two decades, the Surgalign system is the first transformational innovation I’ve seen in the digital realm. Its unique combination of AR/AI will not only allow me to make better decisions for my patients but will allow me to deliver more accurate and efficient care in the surgical environment. It is truly a gamechanger,” said Dr. D. Greg Anderson, Professor in the Departments of Orthopaedic and Neurological Surgery at Thomas Jefferson University and Clinical Director of the Spine Section of the Orthopaedic Research Laboratory at the Rothman Institute.

“Training the next generation of spinal surgeons will require innovative technologies to enhance the understanding of difficult anatomy and provide a more standardized pathway in the delivery of spine care. Surgalign is advancing digital solutions to significantly improve spine surgery,” said Dr. Rajiv Sethi who is the Chair of the Neuroscience Institute, Director of Spine Research, and Director of Complex Spine Surgery at the Virginia Mason Medical Center in Seattle, Washington. He is also a clinical professor at the University of Washington specializing in health services research in the Program of Health Economics and Outcomes Methodology.

Surgalign’s digital surgical guidance system may offer the opportunity for improved planning and visualization to surgeons in the U.S. who perform more than 1.5 million instrumented spinal procedures each year.

Surgalign’s product is the result of six years of development and testing at Holo Surgical, Inc., by virtual and augmented reality expert Prof. Cristian Luciano, PhD; spine surgeon Dr. Kris Siemionow, MD, PhD; and Prof. Paul Lewicki, PhD, a pioneer in artificial intelligence and predictive analytics. Surgalign acquired Holo Surgical in October of 2020.

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