Surgalign Receives FDA Clearance for HOLO Portal™ System, the World’s First AI-driven AR Steering System for Backbone Surgical procedure and Reviews Preliminary Fourth Quarter and Full Yr 2021 Outcomes
Clearance is to be used within the lumbar portionof the $5 billion instrumented fusion market*
DEERFIELD, Unwell., Jan. 18, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc., (NASDAQ: SRGA) a world medical know-how firm centered on elevating the usual of care by driving the evolution of digital well being, as we speak introduced that it has obtained U.S. Food & Drug Administration (FDA) 510(okay) clearance for its HOLO Portal surgical steering system to be used inside lumbar backbone procedures. The HOLO Portal system is the world’s first synthetic intelligence (AI)-driven augmented actuality (AR) steering system for backbone and the primary medical utility of Surgalign’s HOLOTM AI digital well being platform.
“Receiving the preliminary clearance for the HOLO Portal system is a major milestone and represents a crucial step towards constructing the inspiration of the digital surgical procedure of the long run. This technique is designed to enhance affected person outcomes by delivering clever options to our clients, and we consider it’s really revolutionary,” mentioned Terry Wealthy, Surgalign’s president and chief government officer. “With clearance in hand for our steering utility, our near-term focus is getting the platform into the fingers of surgeons as we work in the direction of a market launch. Whereas the present capabilities of the HOLO Portal system have the potential to supply a quantum leap in the way in which surgical procedures are carried out, we now have a a lot bigger imaginative and prescient for our HOLO AI digital well being platform throughout a wide range of healthcare specialties and all through the care continuum.”
The HOLO Portal system combines machine learning-based picture steering know-how with AR, automated backbone segmentation (i.e., anatomy recognition), and automatic surgical planning using proprietary AI software program. Intraoperative pictures are autonomously processed by the AI system to create a patient-specific plan that’s introduced to the surgeon utilizing the AR show.
“HOLO Portal is the primary substantial innovation I’ve seen within the years of using digital know-how in my observe,” mentioned Dr. D. Greg Anderson, MD, PhD, and Professor within the Departments of Orthopaedic and Neurological Surgical procedure at Thomas Jefferson College and Medical Director of the Backbone Part of the Orthopaedic Analysis Laboratory on the Rothman Institute. “The system’s groundbreaking mixture of AR and AI will higher inform surgical selections for my sufferers and in the end ship extra correct and environment friendly care within the surgical atmosphere. It’s really transformative.”
HOLO Portal is the results of six years of growth and testing at Holo Surgical Inc., by digital and augmented actuality skilled Prof. Cristian Luciano, PhD; backbone surgeon Dr. Kris Siemionow, MD, PhD; and Prof. Paul Lewicki, PhD, a pioneer in AI and predictive analytics and founding father of one of many main and earliest corporations in predictive knowledge mining. Surgalign acquired Holo Surgical in October of 2020.
Professor Lewicki, “I acknowledge the ability related to HOLO know-how, particularly the machine studying and AI algorithms and their skill to revolutionize healthcare. We spent years creating machine studying primarily based neural networks to show the pc anatomy and handle particular surgical wants. The result’s displayed in 3D instantly within the surgeon’s sight view utilizing the AR show, permitting for a sublime circulation of data between the system and the doctor.”
“I consider our know-how has the potential for improved affected person outcomes and diminished operative time as a consequence of autonomous surgical planning and intraoperative steering. The system shows the anatomy in 3D, which permits for much less tissue injury in the course of the surgical process, as a consequence of improved visualization,” added Dr. Siemionow. “When physicians use HOLO, they may understand that the system gives them with info they could presently be lacking—surgeons will shortly see how they’ll leverage the know-how within the working room and past to ship higher care.”
Preliminary Fourth Quarter and Full Yr 2021 Outcomes
Preliminary international income for the quarter ended December 31, 2021, is anticipated to be inside a spread of $21.5 – $21.9 million.
Preliminary international income for the complete 12 months ended December 31, 2021, is anticipated to be inside a spread of $90.2 – $90.6 million.
As of December 31, 2021, preliminary money and money equivalents is anticipated to not be beneath $51.0 million after making an allowance for the money consideration paid for Inteneural Networks Inc. (“INN”).
About Surgalign Holdings, Inc.
Surgalign Holdings, Inc. is a world medical know-how firm dedicated to the promise of digital well being to drive transformation throughout the surgical panorama. Uniquely aligned and resourced to advance the usual of care, the corporate is constructing applied sciences physicians and different well being suppliers will look to for what is really potential for his or her sufferers. Surgalign is targeted on creating options that predictably ship superior medical and financial outcomes. Surgalign markets merchandise all through the USA and in additional than 50 nations worldwide by an increasing community of high impartial distributors. Surgalign is headquartered in Deerfield, IL, with business, innovation and design facilities in San Diego, CA, Warsaw and Poznan, Poland, and Wurmlingen, Germany. Study extra at www.surgalign.com and join on LinkedIn and Twitter.
Ahead Wanting Assertion
This press launch comprises forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995. These forward-looking statements are primarily based on administration’s present expectations, estimates and projections about our business, our administration’s beliefs and sure assumptions made by our administration. Phrases corresponding to “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such phrases and comparable expressions are meant to establish such forward-looking statements. The forward-looking statements are usually not ensures of future efficiency and are primarily based on sure assumptions together with common financial situations, in addition to these throughout the Firm’s business, and quite a few different components and dangers recognized within the Firm’s most up-to-date Type 10-Ok and different filings with the SEC. Our precise outcomes might differ materially from the anticipated outcomes mirrored in these forward-looking statements. Vital components that might trigger precise outcomes to vary materially from the anticipated outcomes mirrored in these forward-looking statements embrace dangers and uncertainties regarding the next: (i) dangers regarding current or potential litigation or regulatory motion arising from the beforehand introduced SEC and inner investigations and their findings; (ii) the identification of management deficiencies, together with materials weaknesses in inner management over monetary reporting and the affect of the identical; (iii) potential reputational injury that the Firm has or might undergo because of the findings of the SEC and inner investigations and associated litigation; (iv) common worldwide financial situations and associated uncertainties; (v) the continued affect of the COVID-19 novel coronavirus pandemic and the Firm’s makes an attempt at mitigation, notably in worldwide markets served by the Firm; (vi) the failure by the Firm to establish, develop and efficiently implement its strategic initiatives, notably with respect to its digital surgical procedure technique; (vii) the reliability of our provide chain; (viii) our skill to fulfill obligations, together with buy minimums, underneath our vendor and different agreements; (ix) the period of decreased demand for our merchandise; (x) whether or not or when the demand for procedures involving our merchandise will enhance; (xi) the Firm’s entry to satisfactory working money circulation, commerce credit score, borrowed funds and fairness capital to fund its operations and pay its obligations as they change into due, and the phrases on which exterior financing could also be out there, together with the affect of antagonistic traits or disruption within the international credit score and fairness markets; (xii) our monetary place and outcomes, whole income, product income, gross margin, and operations; (xiii) failure to understand, or surprising prices in in search of to understand, the anticipated advantages of the Holo Surgical, Inc. (“Holosurgical”) and Inteneural Networks (“INN”) acquisitions, together with the failure of Holosurgical’s and INN’s services and products to be satisfactorily developed or obtain relevant regulatory approvals or because of the failure to commercialize and distribute their merchandise; (xiv) the failure to successfully combine Holosurgical’s and INN’s operations with these of the Firm, together with: retention of key personnel; the impact on relationships with clients, suppliers, and different third events; and the diversion of administration time and a spotlight to the mixing; (xv) the variety of shares and amount of money that will probably be required in reference to any post-closing milestone funds, together with because of modifications within the buying and selling worth of the Firm’s frequent inventory and their impact on the amount of money wanted by the Firm to fund any post-closing milestone funds in reference to the acquisitions; (xvi) the impact of the resignation of our auditor in early 2021 and our skill to efficiently transition to our new auditor; (xvii) the continuation of current high quality points with respect to our international provide chain; (xviii) the results of resignations from our Board of Administrators and government management group in 2021, together with our skill to seek out certified candidates to fill these vacancies; (xix) the impact and timing of modifications in legal guidelines or in governmental laws; and (xx) different dangers described in our public filings with the SEC. These components ought to be thought of rigorously, and undue reliance shouldn’t be positioned on the forward-looking statements. Every forward-looking assertion on this communication speaks solely as of the date of the actual assertion. Copies of the Firm’s SEC filings could also be obtained by contacting the Firm or the SEC or by visiting Surgalign’s web site at www.surgalign.com or the SEC’s web site at www.sec.gov. We undertake no obligation to replace these forward-looking statements besides as could also be required by regulation.
Investor and Media Contact: Mike Vallie IR@surgalign.com +1 443 213 0499