Exhibit 99.1
Surgalign Receives FDA Clearance for HOLO Portal™ System, the World’s First AI-driven AR Guidance System for Spine Surgery and Reports Preliminary Fourth Quarter and Full Year 2021 Results
Clearance is for use in the lumbar portion of the $5 billion instrumented fusion market*
DEERFIELD, Ill., Jan. 18, 2022 – Surgalign Holdings, Inc., (NASDAQ: SRGA) a global medical technology company focused on elevating the standard of care by driving the evolution of digital health, today announced that it has received U.S. Food & Drug Administration (FDA) 510(k) clearance for its HOLO Portal surgical guidance system for use within lumbar spine procedures. The HOLO Portal system is the world’s first artificial intelligence (AI)-driven augmented reality (AR) guidance system for spine and the first clinical application of Surgalign’s HOLOTM AI digital health platform.
“Receiving the initial clearance for the HOLO Portal system is a significant milestone and represents a critical step toward building the foundation of the digital surgery of the future. This system is designed to improve patient outcomes by delivering intelligent solutions to our customers, and we believe it is truly revolutionary,” said Terry Rich, Surgalign’s president and chief executive officer. “With clearance in hand for our guidance application, our near-term focus is getting the platform into the hands of surgeons as we work towards a market release. While the current capabilities of the HOLO Portal system have the potential to offer a quantum leap in the way surgical procedures are performed, we have a much larger vision for our HOLO AI digital health platform across a variety of healthcare specialties and throughout the care continuum.”
The HOLO Portal system combines machine learning-based image guidance technology with AR, automated spine segmentation (i.e., anatomy recognition), and automated surgical planning utilizing proprietary AI software. Intraoperative images are autonomously processed by the AI system to create a patient-specific plan that is presented to the surgeon using the AR display.
“HOLO Portal is the first substantial innovation I’ve seen in the years of utilizing digital technology in my practice,” said Dr. D. Greg Anderson, MD, PhD, and 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. “The system’s groundbreaking combination of AR and AI will better inform surgical decisions for my patients and ultimately deliver more accurate and efficient care in the surgical environment. It is truly transformative.”
HOLO Portal 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 AI and predictive analytics and founder of one of the leading and earliest companies in predictive data mining. Surgalign acquired Holo Surgical in October of 2020.
Professor Lewicki, “I recognize the power associated with HOLO technology, specifically the machine learning and AI algorithms and their ability to revolutionize healthcare. We spent years developing machine learning based neural networks to teach the computer anatomy and address specific surgical needs. The result is displayed in 3D directly in the surgeon’s field of vision using the AR display, allowing for an elegant flow of information between the system and the physician.”
* | Source: SmartTRAK Business Intelligence. |