ATEC Expands Platform with Launch of InVictus® OsseoScrew® Expandable Spinal Fixation
29 September 2021 - 3:00PM
Business Wire
First and only commercially available
expandable pedicle screw technology designed to optimize fixation
and address the clinical challenge of fixation failure in
compromised bone
Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative
solutions dedicated to revolutionizing the approach to spine
surgery, announced today the launch of the InVictus OsseoScrew
Expandable Spinal Fixation System.
InVictus OsseoScrew has been designed to be an alternative to
the conventional use of cemented fenestrated screws for patients
with compromised bone. The system is intended to restore spinal
column integrity, even in the absence of fusion, in patients with
advanced stage tumors involving the thoracic and lumbar spine in
whom life expectancy is of insufficient duration to permit
achievement of fusion. An expansion of the InVictus Posterior
Fixation Platform, InVictus OsseoScrew integrates seamlessly with
InVictus MIS and Open platforms as well as SafeOp™ Automated
EMG.
“InVictus OsseoScrew advances care for patients with compromised
bone quality; a testament of ATEC's pursuit of solutions for unmet
clinical needs," said Pat Miles, Chairman and Chief Executive
Officer. “The system enhances the versatility of InVictus, our
industry-leading comprehensive posterior fixation system, and
provides surgeons with greater optionality to customize patient
care. InVictus OsseoScrew will align well with the level-specific
bone density information that EOS will soon be capable of
ascertaining, establishing a foundation for the next-generation of
ATEC surgical planning.”
With a significant 29 percent increase in pull-out strength
compared to standard pedicle screws1, OsseoScrew is engineered to
address the clinical challenges of treating patients with
compromised bone. In a randomized clinical study In Europe,
patients with the system demonstrated clinical fusion and segment
stability outcomes comparable to cemented fenestrated screws, while
circumventing the risk of perivertebral cement leakage, a
frequently occurring complication that can lead to severe
complications.2 In the study, OsseoScrew demonstrated a
statistically significant lower prevalence of adverse device events
at 8%, compared to over 55% for cemented fenestrated screws.3
Christopher DeWald, MD, Assistant Professor and Director of the
Spine Deformity Section of Rush University, commented, “InVictus
OsseoScrew is a solution for an underserved patient population. The
system allows the surgeon a controlled expansion to optimize
fixation with improved screw purchase, while helping to minimize
the clinical challenge of pedicle screw failure by pull out. It can
be elegantly integrated with SafeOp to provide a more predictable
technique and reinforce confidence during screw insertion.”
Key Features of InVictus Osseoscrew Expandable Spinal
Fixation
- Achieves 29% greater pull-out strength over conventional
pedicle screws
- Designed to optimize pedicle fixation with expansion zone
location
- Promotes stabilization in patients with compromised bone
structures
About ATEC
ATEC, through its wholly owned subsidiaries, Alphatec Spine,
Inc., EOS imaging S.A. and SafeOp Surgical, Inc., is a medical
device company dedicated to revolutionizing the approach to spine
surgery through clinical distinction. ATEC's Organic Innovation
Machine™ is focused on developing new approaches that integrate
seamlessly with the Company’s expanding AlphaInformatiX Platform to
better inform surgery and more safely and reproducibly achieve the
goals of spine surgery. ATEC's vision is to become the Standard
Bearer in Spine. For more information, visit us at
www.atecspine.com
Forward-Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainty. Such statements are based on
management's current expectations and are subject to many risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. The Company
cautions investors that there can be no assurance that actual
results will not differ materially from those projected or
suggested in such forward-looking statements as a result of various
factors. Forward-looking statements include references to the
Company’s planned commercial launches, product introductions and
product integration, surgeon and market acceptance of Company
products and the Company’s ability to deliver key product features.
The important factors that could cause actual operating results to
differ significantly from those expressed or implied by such
forward-looking statements include, but are not limited to: the
uncertainty of success in developing new products or products
currently in the Company’s pipeline; failure to achieve acceptance
of the Company’s products; failure to obtain FDA or other
regulatory clearance or approval for new products, or unexpected or
prolonged delays in the process; continuation of favorable third
party reimbursement; the Company’s ability to compete with other
products and with emerging new technologies; product liability
exposure; patent infringement claims; and claims related to the
Company’s intellectual property. The words “believe,” “will,”
“should,” “expect,” “intend,” “estimate,” “look forward” and
“anticipate,” variations of such words and similar expressions
identify forward-looking statements, but their absence does not
mean that a statement is not a forward-looking statement. A further
list and description of these and other factors, risks and
uncertainties can be found in the Company’s most recent annual
report, and any subsequent quarterly and current reports, filed
with the Securities and Exchange Commission. ATEC disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise unless required by law.
1 Vishnubhotla S, McGarry WB, Mahar AT, et al. A titanium
expandable pedicle screw improves initial pullout strength as
compared with standard pedicle screws. Spine J 2011;11:777-81.
2 Zhang J, Wang G, Zhang N. A meta-analysis of complications
associated with the use of cement-augmented pedicle screws in
osteoporosis of spine. Orthop Traumatol Surg Res 2020 Dec
15:102791.
3 Data on file.
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version on businesswire.com: https://www.businesswire.com/news/home/20210929005313/en/
Investor/Media Contact: Tina Jacobsen, CFA Investor
Relations (760) 494-6790 investorrelations@atecspine.com
Company Contact: J. Todd Koning Chief Financial Officer
Alphatec Holdings, Inc. investorrelations@atecspine.com
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