Surgalign Announces 100th Case Completed Utilizing its Recently Launched Cortera™ Spinal Fixation System
15 Décembre 2022 - 2:30PM
Surgalign Holdings, Inc. (Nasdaq: SRGA), a global medical
technology company focused on elevating the standard of care by
driving the evolution of digital surgery, today announced a key
milestone for its recently introduced posterior fixation platform –
the Cortera™ Spinal Fixation System.
Surgalign received FDA 510(k) in August 2022 and Cortera and was
introduced in a limited market release shortly thereafter. In a
little over three months, the Company has successfully penetrated
target markets and today announced the completion of the 100th case
utilizing this new flagship pedicle screw system. During this
initial market release, Surgalign’s goal has been to collect
clinical and design feedback on the system from a wide range of
spine surgeons, representing the user needs and preferences of the
broader market. Efforts are now underway to secure additional
products and the Company intends to ramp up commercialization in
the first half of 2023 as it looks to grow its market share in the
estimated $2.2B US posterior fixation market.
“My early experience utilizing the Cortera system has been
incredibly promising,” said Dr. Sergey Neckrysh, Chief of
Spine Surgery at UI Health in Chicago, Illinois. “The
first generation of the system boasts a higher quality than many
screw systems that have been on the market for years. I treat a
range of patients presenting with basic degenerative pathologies to
complex deformities and revision needs, and I have found the
Cortera system to be a robust and reliable surgical solution that
allows me to provide best-in-class care to my patients.”
The Cortera system was designed based on feedback from some of
the most experienced and knowledgeable surgeons and engineers in
the world and at its core, is a 5.5/6.0mm rod pedicle screw system,
that has both open and MIS modules. The system boasts a
feature-rich screw design that maintains a comparatively low
profile and a newly designed locking mechanism. As previously
communicated, the Company intends to develop additional implants
and instruments to add to the Cortera System over the next 3-4
years and is also working to integrate Cortera with its HOLO
Portal™ surgical guidance system.
Terry Rich, President and Chief Executive Officer of Surgalign
stated, “Cortera represents the first organically developed product
at Surgalign and we believe holds great promise for our Company and
our customers. Market reception has been very strong to date and we
look forward to moving into the next phase of our commercial launch
in 2023, while continuing to drive innovation in the system.”
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 and
Twitter.
Forward Looking StatementsThis press release
contains forward-looking statements including, without limitation,
statements relating the intended use of proceeds from the
registered direct offering. These forward-looking statements are
based on management’s current expectations, estimates and
projections about our industry, our management’s beliefs and
certain assumptions made by our management. 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. Factors that
could cause actual results to differ materially from those
forward-looking statements include: 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 and
(xv) the effect and timing of changes in laws or in governmental
regulations. 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.
These forward-looking statements are not guarantees of future
performance and are subject to various risks and uncertainties,
including market and other conditions and the risks identified in
Surgalign’s most recent Annual Report on Form 10-K and other
filings with the SEC. Our actual results may differ materially from
the anticipated results reflected in these forward-looking
statements. Copies of Surgalign’s SEC filings may be obtained
without charge by visiting Surgalign’s website at www.surgalign.com
or the SEC’s website at 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
Wienergwiener@surgalign.com+ 1 917 887-8434 |
Surgalign Contact:Kristine
Simmonsksimmons@surgalign.com+ 1 619 206 4648 |
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