Surgalign™ Expands Adoption of its HOLO Portal™ Surgical Guidance System in Virginia
13 Décembre 2022 - 6:00PM
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 StatementThis 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.
Investor and Media Contact: Glenn Wiener
gwiener@gwcco.com+ 1 917 887 8434 |
Surgalign Contact:Kristine
Simmonsksimmons@surgalign.com+1 619 206 4648 |
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