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

Rhea-AI Summary

Surgalign Spine Technologies (NASDAQ: SRGA) announced the submission of a premarket notification 510(k) to the FDA for its innovative digital surgical guidance system. This system integrates augmented reality (AR) and artificial intelligence (AI) to provide real-time surgical guidance, enhancing accuracy in spinal surgeries. Developed over six years, this system allows surgeons to visualize patient-specific anatomy during procedures. The company aims to improve the efficiency of over 1.5 million annual instrumented spinal surgeries in the U.S. with this ground-breaking technology.

Positive

• Submission of 510(k) to FDA for a digital surgical guidance system.
• Combines AR and AI for enhanced surgical accuracy.
• Developed over six years, indicating strong R&D efforts.
• Potential to improve outcomes in over 1.5 million U.S. spinal surgeries per year.

Negative

• FDA clearance for the 510(k) is uncertain and is not guaranteed.

Augmented Reality and Artificial Intelligence Technology Acquired Via Holo Surgical Acquisition

DEERFIELD, Ill., May 10, 2021 (GLOBE NEWSWIRE) -- 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.

About Surgalign Holdings, Inc.

Surgalign Holdings, Inc. is a global medical technology company committed to the promise of digital surgery and is building out its digital surgery platform to drive transformation across the surgical landscape. Uniquely aligned and resourced to advance the standard of care, the company is building technologies surgeons will look to for what is truly possible for their patients. Surgalign is focused on bringing surgeons solutions that predictably deliver superior clinical and economic outcomes.

Surgalign markets products throughout the United States and in more than 50 countries worldwide through an expanding network of top independent distributors. Surgalign, a member of AdvaMed, is headquartered in Deerfield, IL, with commercial, innovation and design centers in San Diego, CA, Marquette, MI, and Wurmlingen, Germany. Learn more at www.surgalign.com and connect on LinkedIn and Twitter.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management's beliefs and certain assumptions made by our management. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," variations of such words and similar expressions are intended to identify
such forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including whether the FDA will clear the premarket notification 510(k) and the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company's SEC filings may be obtained by contacting the company or the SEC or by visiting Surgalign's website at www.surgalign.com or the SEC's website at www.sec.gov.

¹Pending 510(k), not available for sale within the United States

Investor and Media Contact:
Jonathon Singer
jsinger@surgalign.com
+1 224 303 4651

FAQ

What new technology has Surgalign submitted to the FDA?

Surgalign has submitted a premarket notification 510(k) for its digital surgical guidance system that utilizes augmented reality and artificial intelligence.

What is the significance of the 510(k) submission for SRGA?

The 510(k) submission is crucial for obtaining FDA clearance, which would allow the marketing of Surgalign's innovative surgical technology.

How does Surgalign's system improve spinal surgeries?

The system offers real-time visualization of internal anatomy and surgical guidance, enhancing precision during procedures.

What impact could Surgalign's system have on spinal surgeries?

It has the potential to improve the efficiency and outcomes of over 1.5 million instrumented spinal procedures performed annually in the U.S.