Surgalign™ Expands Adoption of its HOLO Portal™ Surgical Guidance System in Virginia
Richmond, VA medical facility is fourth to clinically use HOLO Portal, the world’s first artificial intelligence (AI)-driven, augmented reality (AR) guidance system for spine surgery
DEERFIELD, Ill., Dec. 13, 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 additional commercialization of its HOLO Portal surgical guidance system. The Company is pleased to report that multiple cases have been successfully performed in Virginia leveraging the HOLO Portal system, with the first case performed by Joshua P. Herzog, MD, a board-certified orthopedic spine surgeon with OrthoVirginia in Richmond, Virginia.
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.
In January 2022, Surgalign 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 working to expand the system’s limited market release and intends to further increase 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.
“I am confident that the increased precision and ability of this enabling technology will improve the recovery and outcome for my patients,” said Dr. Herzog. Terry Rich, President and CEO of Surgalign, added, “Congratulations to Dr. Herzog and the team at OrthoVirginia for completing the first clinical case in Virginia with the Surgalign HOLO Portal system. The performance of the system to date coupled with the positive surgeon feedback generated by the technology, continues to validate our high expectations and drive our overall goal to transform patient outcomes with our AI technology.”
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 approximately 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, Twitter and Instagram.
Forward Looking Statement
This press release contains forward-looking statements based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management, and such forward-looking statements include (among others) statements regarding anticipated future financial and operating performance (including forecasted full-year revenue and number of HOLO sites secured), product rationalization and expense reduction initiatives and the results thereof, potential third party financing and anticipated cash needs. 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. The forward-looking statements are not guarantees of future performance and are based on certain assumptions including general economic conditions, as well as those within the Company’s industry, and numerous other factors and risks identified in the Company’s most recent Form 10-K, 10-Q 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 risks and uncertainties relating to the following: (i) the Company’s access to adequate operating cash flow, trade credit, borrowed funds and equity capital to fund its operations and pay its obligations as they become due, and the terms on which external financing may be available, including the impact of adverse trends or disruption in the global credit and equity markets; (ii) risks relating to existing or potential litigation or regulatory actions; (iii) the identification of control deficiencies, including material weaknesses in internal control over financial reporting; (iv) general worldwide economic conditions and related uncertainties; (v) the continued impact of the COVID-19 and the Company’s attempts at mitigation, particularly in international markets served by the Company; (vi) the failure by the Company to identify, develop and successfully implement its strategic initiatives, particularly with respect to its digital surgery strategy; (vii) the reliability of our supply chain; (viii) our ability to meet obligations, including purchase minimums, under our vendor and other agreements; (ix) whether or when the demand for procedures involving our products will increase; (x) our financial position and results, total revenue, product revenue, gross margin, and operations; (xi) failure to realize, or unexpected costs in seeking to realize, the expected benefits of the Holo Surgical Inc. (“Holo Surgical”) and Inteneural Networks Inc. (“INN”) acquisitions, including the failure of Holo Surgical’s and INN’s products and services to be satisfactorily developed or achieve applicable regulatory approvals or as a result of the failure to commercialize and distribute its products; (xii) the failure to effectively integrate Holo Surgical’s and INN’s operations with those of the Company, including: retention of key personnel; the effect on relationships with customers, suppliers, and other third parties; and the diversion of management time and attention to the integration; (xiii) 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 trading price of the Company’s common stock and their effect on the amount of cash needed by the Company to fund any post-closing milestone payments in connection with the acquisitions; (xiv) the continuation of recent quality issues with respect to our global supply chain; (xv) the effect and timing of changes in laws or in governmental regulations; and (xvi) other risks described in our public filings with the SEC. These factors should be considered carefully, and undue reliance should not be placed on the forward-looking statements. Each forward-looking statement in this communication speaks only as of the date of the particular statement. Copies of the Company's SEC filings may be obtained by contacting the Company or the SEC or by visiting Surgalign’s website at http://www.surgalign.com/ or the SEC’s website at http://www.sec.gov/. We undertake no obligation to update these forward-looking statements except as may be required by law.
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Released December 13, 2022