Surgalign Receives FDA Clearance for the HOLO Portal™ System, the 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 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc., (NASDAQ: SRGA), a global medical technology company focused on raising the standard of care by driving the evolution of health digital, today announced that it has received 510(k) clearance from the United States Food & Drug Administration (FDA) for its HOLO Portal surgical guidance system for use in lumbar spine procedures. The HOLO Portal System is Surgalign’s First Artificial Intelligence (AI) Driven Augmented Reality (AR) Guidance System for the Spine and First Clinical Application of HOLOMT AI digital health platform.

“Receiving initial clearance for the HOLO Portal system is an important milestone and represents a critical step towards building the foundations for digital surgery of the future. This system is designed to improve patient outcomes by providing smart solutions to our customers, and we believe it is truly revolutionary,” said Terry Rich, President and CEO of Surgalign. “With pending approval for our guidance app, our short-term goal is to get the platform into the hands of surgeons as we work towards a market launch. Although the current capabilities of the HOLO Portal system have the potential to deliver a quantum leap in the way surgical procedures are performed, we have a much broader vision for our HOLO AI digital health platform in a variety of healthcare specialties and across the continuum of care. “

The HOLO Portal system combines machine learning-based image guidance technology with AR, automated spine segmentation (i.e. anatomy recognition), and automated surgical planning to using 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 years of using digital technology in my practice,” said Dr. D. Greg Anderson, MD, PhD, and Professor in the Departments of Orthopedic Surgery and Neurology from Thomas Jefferson University. and Clinical Director of the Spine Section of the Rothman Institute Orthopedic Research Laboratory. “The system’s revolutionary combination of AR and AI will better inform surgical decisions for my patients and ultimately provide more accurate and efficient care in the surgical environment.” It’s really transformative. »

HOLO Portal is the result of six years of development and testing at Holo Surgical Inc., by Professor Cristian Luciano, PhD, virtual and augmented reality expert; spine surgeon Dr. Kris Siemionow, MD, PhD; and Professor Paul Lewicki, PhD, pioneer of AI and predictive analytics and founder of one of the first and largest predictive data mining companies. Surgalign acquired Holo Surgical in October 2020.

Professor Lewicki, “I recognize the power associated with HOLO technology, especially machine learning and AI algorithms and their ability to revolutionize healthcare. We have spent years developing neural networks based on the machine learning to teach computational 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 an elegant flow of information between the system and the doctor.

“I believe our technology has the potential to improve patient outcomes and reduce operative time through self-directed surgical planning and intraoperative guidance. The system displays anatomy in 3D, resulting in less tissue damage during surgery, due to better visualization,” added Dr. Siemionow. “When physicians use HOLO, they will realize that the system provides them with information they may currently be missing. Surgeons will quickly see how they can leverage technology in the operating room and beyond to provide better care.”

Preliminary results for the fourth quarter and full year 2021

Preliminary worldwide revenue for the quarter ended December 31, 2021 is expected to be in the range of $21.5-21.9 million.

Preliminary worldwide revenue for the full fiscal year ended December 31, 2021 is expected to be in the range of $90.2-90.6 million.

As of December 31, 2021, preliminary cash and cash equivalents are not expected to be less than $51.0 million after taking into account the cash consideration paid for Inteneural Networks Inc. (“INN”).

About Surgalign Holdings, Inc.

Surgalign Holdings, Inc. is a global medical technology company committed to the promise of digital health to drive transformation in the surgical landscape. Uniquely aligned and resourced to advance the standard of care, the company develops technologies that physicians and other healthcare providers will turn 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 its products in the United States and in more than 50 countries around the world through a growing network of leading independent distributors. Surgalign is headquartered in Deerfield, IL, with shopping, innovation and design centers in San Diego, California, 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 industry, the beliefs of our management and certain assumptions made by our management. . Words such as “anticipate”, “expect”, “intend”, “anticipate”, “believe”, “seek”, “estimate”, variations of these words and similar expressions are intended to identify these forward-looking statements. Forward-looking statements are not guarantees of future performance and are based on certain assumptions, including general economic conditions, as well as those in the company’s industry, and numerous other factors and risks identified in Form 10-K most recent company and other filings. with the SEC. Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Important factors that could cause actual results to differ materially from the anticipated results reflected in these forward-looking statements include the risks and uncertainties associated with the following: (i) risks relating to existing or potential litigation or actions regulatory matters arising from previously announced SEC and internal investigations and their findings; (ii) identification of control deficiencies, including material weaknesses in internal control over financial reporting and the impact thereof; (iii) potential reputational harm that the Company has or may suffer as a result of the findings of the SEC and related internal investigations and litigation; (iv) general global economic conditions and associated uncertainties; (v) the continued impact of the novel coronavirus COVID-19 pandemic and the Company’s attempts to mitigate it, particularly in the international markets served by the Company; (vi) the Company’s inability to successfully identify, develop and implement its strategic initiatives, including with respect to its digital surgery strategy; (vii) the reliability of our supply chain; (viii) our ability to meet our obligations, including purchase minimums, under our supplier and other agreements; (ix) the duration of the decline in demand for our products; (x) if or when demand for procedures involving our products will increase; (xi) the Company’s access to adequate operating cash flow, trade credit, borrowed funds and equity to fund its operations and pay its obligations as they come due, and the terms on which external financing may to be available, including the impact of adverse trends or disruptions in the global credit and equity markets; (xii) our financial condition and results, total revenues, products, gross margin and operations; (xiii) failure to realize or unanticipated costs related to the pursuit of anticipated benefits of the acquisitions of Holo Surgical, Inc. (“Holosurgical”) and Inteneural Networks (“INN”), including failure of products and services Holosurgical and INN from being satisfactorily developed or obtaining applicable regulatory approvals or due to the failure to commercialize and distribute their products; (xiv) failure to effectively integrate the businesses of Holosurgical and INN with those of the Company, including: retention of key personnel; the effect on relationships with customers, suppliers and other third parties; and diversion of management time and attention to integration; (xv) the number of shares and amount of cash that will be required in connection with any post-closing milestone payments, including as a result of changes in the market price of the Company’s common stock and their effect on the amount of cash required by the Company to fund all post-closing milestone payments related to the acquisitions; (xvi) the effect of our auditor’s resignation in early 2021 and our ability to successfully transition to our new auditor; (xvii) the persistence of recent quality issues with our global supply chain; (xviii) the effects of the resignations of our board of directors and our management team in 2021, including our ability to find qualified candidates to fill these vacancies; (xix) the effect and timing of changes in laws or governmental regulations; and (xx) other risks described in our public filings with the SEC. These factors should be carefully considered and should not place undue reliance on forward-looking statements. Each forward-looking statement contained in this communication speaks only as of the date of the particular statement. Copies of the Company’s filings with the SEC may be obtained by contacting the Company or the SEC or by visiting Surgalign’s website at www.surgalign.com or the SEC website at www.sec.gov. We undertake no obligation to update these forward-looking statements, except as required by law.

*Source: SmartTRAK Business Intelligence.