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Surgalign™ Announces Clinical Site Expansion in the Commercialization of its HOLO Portal™ Surgical Guidance System in Ohio

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Surgalign Holdings announced the clinical use of its HOLO Portal, the first AI-driven augmented reality guidance system for spine surgery. Dr. Selvon St. Clair performed the first surgery using this system at the Orthopaedic Institute of Ohio. The HOLO Portal utilizes AI for real-time 3D visualization, improving surgical precision. Surgalign received FDA clearance for lumbar spine procedures earlier this year and is expanding its market release. CEO Terry Rich expressed optimism about the technology's potential to enhance patient outcomes.

Positive
  • Successful first surgery using HOLO Portal performed by Dr. Selvon St. Clair.
  • HOLO Portal is the first AI and AR surgical guidance system, enhancing 3D visualization.
  • FDA clearance received for HOLO Portal usage in lumbar spine procedures.
  • Plans for further expansion and new applications on the HOLO platform.
Negative
  • None.

This marks the second medical facility to clinically use HOLO Portal, the world’s first artificial intelligence (AI)-driven, augmented reality (AR) guidance system for spine surgery

DEERFIELD, Ill., July 06, 2022 (GLOBE NEWSWIRE) -- 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 continued momentum in the commercialization of its HOLO Portal surgical guidance system. The Company is pleased to report that Selvon St. Clair, MD, PhD, and a board certified orthopaedic and spinal surgeon at the Orthopaedic Institute of Ohio, performed his first case with the HOLO Portal system.

HOLO Portal is the world’s first surgical guidance system to incorporate AI and AR. This is the first clinical application of Surgalign’s HOLO™ AI digital health platform. The system’s AI processes intraoperative images to autonomously segment and label the anatomy and plan patient-specific pedicle screw trajectories that are approved by the surgeon. The HOLO Portal system uses AR to overlay the segmented AI reconstruction over the patient’s actual anatomy, providing real-time 3D visualization throughout the surgical procedure. This AR display helps surgeons visualize trajectories and guides surgical instruments.

“With previous technology the surgeon has had to process three 2D images on a monitor across the room increasing the cognitive load on the surgeon in the case. With the HOLO Portal system, the AI anatomic segmentation displayed through AR provides a 3D visualization within the surgical field. My first case was seamless—easy to setup, and the crisp holographic image facilitated precise screw positioning increasing my confidence in the system,” said Dr. St. Clair, who completed his orthopedic surgery residency at Cleveland Clinic and his spine fellowship at Emory University School of Medicine Spine Center, GA.

Dr. Frank Fumich, also of the Orthopaedic Institute of Ohio, added, “The system continues to impress me as well, but more importantly, the technology will help patients by displaying key guidance information within the surgical field with minimal distractions. We look forward to utilizing the HOLO Portal surgical guidance system as we continuously look for new and innovative ways to improve patient outcomes.”

In January 2022, the Company received U.S. Food & Drug Administration (FDA) 510(k) clearance for use of the HOLO Portal system within lumbar spine procedures. The Company is currently expanding the system’s limited market release and intends to ramp up its site locations throughout the year. As cases are performed and data is accumulated, the Company also intends to integrate new applications on its platform to advance the quality of care and improve outcomes for patients.

“Congratulations to Dr. St. Clair for completing the first surgical case in Ohio with the Surgalign HOLO Portal system,” said Terry Rich, President and CEO of Surgalign. “We couldn’t be more pleased with the performance of our HOLO Portal system to date, and the surgeon excitement generated by the technology is palpable. We believe to be on the cusp of something special here at Surgalign and look forward to bringing the benefit of HOLO Portal technology to thousands more patients to come.”

About Surgalign Holdings, Inc.
Surgalign Holdings, Inc. is a global medical technology company committed to the promise of digital health to drive transformation across the surgical landscape. Uniquely aligned and resourced to advance the standard of care, the Company is building technologies physicians and other health providers will look to for what is truly possible for their patients. Surgalign is focused on developing 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 is headquartered in Deerfield, IL, with commercial, innovation and design centers in San Diego, CA, Warsaw and Poznan, Poland, 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 products, company, and industry, our management's beliefs, and certain assumptions made by our management. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," and other variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include statements regarding the features, capabilities and benefits of the HOLO Portal system. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in our 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.

Investor and Media Contact:
Glenn Wiener
gwiener@gwcco.com
+1 917 887 8434
Surgalign Contact:
Kristine Simmons
ksimmons@surgalign.com
+1 619 206 4648

 


FAQ

What is the HOLO Portal system by Surgalign?

HOLO Portal is the world's first AI-driven augmented reality surgical guidance system for spine surgery, providing real-time 3D visualization.

When was the first surgery using the HOLO Portal performed?

The first surgery using the HOLO Portal was performed on July 6, 2022, by Dr. Selvon St. Clair.

What FDA clearance has Surgalign received for the HOLO Portal?

Surgalign received FDA 510(k) clearance for the HOLO Portal system for use in lumbar spine procedures in January 2022.

What are the benefits of using the HOLO Portal in surgery?

The HOLO Portal improves surgical precision through AI-driven 3D visualization, reducing cognitive load on surgeons and enhancing patient outcomes.

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