ATEC Announces Novel PTP Approach
October 05 2020 - 5:13PM
Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq:
ATEC), a medical device company dedicated to revolutionizing the
approach to spine surgery, announced today that over 500 prone
transpsoas, or PTP™, surgeries have been successfully performed at
multiple sites across the United States. The Company is
on track to commercially launch the PTP procedure early in the
fourth quarter.
Designed by the team that created the lateral
approach for spine fusion, ATEC’s PTP technique leverages the
benefits achieved via lateral spine fusion procedures to treat a
wide range of patient pathologies. Its principal difference from
the standard lateral procedure relies on positioning the patient
prone, allowing for a streamlined surgical approach that addresses
many of the challenges that have limited adoption of lateral spine
fusion. Specifically, the PTP approach minimizes unnecessary
patient repositioning, enhances time efficiencies, provides
surgeons increased optionality, and more reproducibly achieves
spinal alignment objectives. The comprehensive approach seamlessly
integrates the PTP Patient Positioning System, the SIGMA-PTP Access
System, IdentiTi indication-specific interbody solutions, the
InVictus Spinal Fixation System, and importantly, the SafeOp Neural
InformatiX System, which objectively monitors the location and the
intraoperative health of the lumbar plexus.
“The team that disrupted the spine market with
XLIF® has leveraged decades of lateral experience and procedural
know-how to revolutionize spine surgery once again,” said Pat
Miles, Chairman and Chief Executive Officer. “Where lateral surgery
has been one of the fastest growing segments in spine, we estimate
that adoption has only reached roughly 30% of surgeons. Prone
patient positioning is not only more familiar to spine surgeons, it
also enables a consistent orthogonal surgical approach that
improves predictability and surgical reproducibility. The result is
an approach that is more accessible and capable of addressing the
entire market for lumbar surgery, not just lateral fusion
procedures.”
Miles continued, “While others repurpose systems
designed for something else and validate with cadaveric testing,
ATEC’s edge is in the development of procedure-specific solutions
that thoughtfully optimize the entire approach. We are applying the
learnings from over 500 surgeries to build a successful technique
from the ground up. We designed the first-of-its-kind PTP patient
positioner to obviate the current arduous and inconsistent practice
of taping patients to the OR table for lateral decubitus spine
surgery. The PTP positioner exactly situates the patient so that
surgeons can maximize the spinal alignment and other anatomic
benefits of prone positioning and increase access to challenging
L4-L5 levels. We also developed an approach-specific retractor,
which attaches robustly to the patient positioner to maintain both
the patient and the retractor’s position throughout the surgery.
Spine’s greatest lateral expertise is at ATEC, and we are eager to
champion an entirely new paradigm for lateral surgery.”
Luiz Pimenta, MD, PhD, ATEC’s Chief Medical
Officer and the spine surgeon recognized as the pioneer of the
lateral approach affirmed, “PTP is clearly the next step forward
for lateral surgery, a conviction that I shared with a surprised
audience at last year’s NASS (North American Spine Society)
Conference. It brings together the benefits of a less invasive
transpsoas (orthogonal)approach with the advantages of an ergonomic
prone position. The positioning allows for reproducible
single-position surgery that enables surgeons to achieve sagittal
alignment goals, the most crucial determinant of long-term spine
surgery patient outcomes.1 With over 500 PTP surgeries performed to
date, we have set new standards, fine-tuned the technique and
acquired incredible confidence in its potential to meaningfully
advance spine fusion surgery.”
PTP technology will be highlighted this week at
ATEC’s virtual NASS booth. Please click here, or visit Booth
1525.
The PTP approach was featured in the European
Spine Journal, a peer-reviewed publication, in May 2020. Click here
to access the article.
About Alphatec Holdings,
Inc.
Alphatec Holdings, Inc. (ATEC), through its
wholly-owned subsidiaries, Alphatec Spine,
Inc. 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 SafeOp Neural InformatiX System to safely and reproducibly
treat spine’s various pathologies and achieve the goals of spine
surgery. Alphatec’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 a number of 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,
solutions and platforms, 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 by the
surgeon community; 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 for procedures performed using the Company’s
products; 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.
Investor/Media Contact:Tina
JacobsenInvestor Relations (760)
494-6790ir@atecspine.com
Company Contact:Jeff BlackChief Financial
OfficerAlphatec Holdings, Inc. ir@atecspine.com
1 Pimenta, AMaral, Taylor, Tohmeh, Pokorny, Rodrigues, Arnoni,
Guirelli, Batista (May 2020) The prone transpsoas technique:
preliminary radiographic results of a multicenter experience.
European Spine Journal.
https://doi.org/10.1007/s00586-020-06471-y
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