Treace Highlights New Product Innovations and Updated ALIGN3D™ Clinical Study Data at the American Orthopaedic Foot & Ankle Society Annual Meeting 2023
2023年9月20日 - 8:00PM
Treace Medical Concepts, Inc. (“Treace” or the “Company”)
(NasdaqGS: TMCI), a medical technology company driving a
fundamental shift in the surgical treatment of hallux valgus
(commonly known as bunions) through its Lapiplasty® 3D Bunion
Correction® Procedure, today announced it will highlight new
product innovations and present new interim data for the ALIGN3D™
clinical study at the American Orthopaedic Foot & Ankle Society
(AOFAS) Annual Meeting 2023 in Louisville, Kentucky from September
20-23, 2023.
“As the industry’s only company solely focused
on advancing the standard of care in the surgical correction of
bunion and related midfoot deformities, we are excited to feature
our latest R&D innovations to surgeons attending the 2023 AOFAS
conference,” stated John T. Treace, CEO, Founder and Board Member
of Treace. “Our new SpeedPlate™ and Micro-Lapiplasty™ technologies
demonstrate Treace’s commitment to rapid innovation with a focus on
continually iterating the Lapiplasty® System with options for
increased procedural efficiency and reduced incision size
associated with the Lapiplasty® Procedure.”
Mr. Treace continued, “Interim data readouts
from our ongoing ALIGN3D™ clinical study continue to demonstrate
sustained, successful procedural and patient outcomes on additional
patients followed through 36- and 48-months post-procedure. We are
proud to continue our commitment to investing in clinical studies
and expanding the differentiated body of clinical evidence to
advance the Lapiplasty® Procedure as the standard of care for
bunion surgery.”
Several technologies will be highlighted
at Treace’s booth at the AOFAS conference, including:
-
SpeedPlate™ Implant Fixation Platform: This new
platform of Lapiplasty® fixation technology is designed for rapid
insertion while providing dynamic compression of the joint
surfaces. Since it can be implanted through a small 2cm incision,
the SpeedPlate™ technology not only offers broad applicability with
the Company’s standard Lapiplasty® and Adductoplasty® systems, but
also serves as the enabling fixation technology for our
Micro-Lapiplasty™ system. Full commercial launch of the SpeedPlate™
technology is anticipated in the fourth quarter of this year.
-
Micro-Lapiplasty™ Minimally Invasive
System: This advanced instrumentation option is designed
to further reduce the incision size and related tissue dissection
with the Lapiplasty® procedure. The advanced instrument set,
including the Micro-Lapiplasty™ 3-n-1™ Guide and other specialized
surgical instruments, allows the deformity correction and joint
preparation steps of the patented Lapiplasty® Procedure to be
performed through a 2cm incision. The Micro-Lapiplasty™ System is
currently in limited clinical release with full commercial launch
expected in the fourth quarter of this year.
- New
Lapiplasty® Innovations:
Recently commercialized innovations, including the LapiTome™ and
RazorTome™ Osteotomes and Hammertoe PEEK Fixation System, will also
be featured at Treace’s booth and in hands-on training
workshops.
ALIGN3D™ Clinical Study Poster
Presentation
The ALIGN3D™ clinical study poster presentation,
“Primary Endpoint Analysis for a Prospective Multicenter Study
Assessing Radiographic Recurrence and Patient Outcomes Following
Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing”,
will be presented by Robert Santrock, MD of Dovetail Orthopedics,
Fernandina Beach, FL on September 21 from 10:00 am to 10:45 am
ET.
The interim analysis includes 173 patients
treated with the Lapiplasty® Procedure with an average follow-up of
33.4 months. The data showed:
- Early return to
weight bearing in a walking boot at an average 8.4 days
(n=173);
- Low recurrence
rate, defined as loss of radiographic correction (HVA > 20°),
was observed in 0.7% of patients (1 of 151 patients) at 24 months
and 1.1% (1 of 95 patients) at 36 months; and
- 81% reduction in
pain (Visual Analog Scale) reported at 24 months post-procedure
(n=156).
The interim analysis also continued to report
statistically significant improvement in patient-reported outcomes,
including a 92% and 93% improvement in walking/standing as well as
social interaction at 36 months post-procedure, respectively, using
the Manchester-Oxford Foot Questionnaire (MOxFQ) scoring system
(n=100). Additionally, at 36 months post-procedure,
less than 5% of patients were unsatisfied with the overall results
of the procedure (n=96).
The poster, which includes additional details,
can be accessed by AOFAS meeting attendees on a kiosk at the Annual
Meeting or on the mobile app. The Company plans to submit its
primary endpoint ALIGN3D™ manuscript for publication in a top-tier
peer-reviewed foot and ankle journal later in 2023.
More information on Treace’s products can be
found at www.lapiplasty.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. All statements other than statements of
historical fact are forward-looking statements, including, but not
limited to the Company’s expectation that the full commercial
launch of the SpeedPlate™ technology and Micro-Lapiplasty™ System
is anticipated in the fourth quarter of this year; and the Company
plans to submit its primary endpoint ALIGN3D™ manuscript for
publication in a top-tier peer-reviewed foot and ankle journal
later in 2023. Forward-looking statements are based on
management’s current assumptions and expectations of future events
and trends, which affect or may affect the Company’s business,
strategy, operations or financial performance, and actual results
and other events may differ materially from those expressed or
implied in such statements due to numerous risks and uncertainties.
Forward-looking statements are inherently subject to risks and
uncertainties, some of which cannot be predicted or quantified.
Factors that could cause actual results or other events to differ
materially from those contemplated in this press release can be
found in the Risk Factors section of Treace’s public filings with
the Securities and Exchange Commission (SEC), including its Annual
Report on Form 10-K for the year ended December 31, 2022, and any
subsequent Quarterly Report on Form 10-Q or Current Report on Form
8-K. Because forward-looking statements are inherently subject to
risks and uncertainties, you should not rely on these
forward-looking statements as predictions of future events. These
forward-looking statements speak only as of their date and, except
to the extent required by law, the Company undertakes no obligation
to update these statements, whether as a result of any new
information, future developments or otherwise.
Internet Posting of
Information
Treace routinely posts information that may be
important to investors in the “Investor Relations” section of its
website at www.treace.com. The Company encourages investors and
potential investors to consult the Treace website regularly for
important information about Treace.
About the ALIGN3D™ Clinical Study
The ALIGN3D™ clinical study is a prospective,
multicenter, post-market study designed to evaluate outcomes of the
Lapiplasty® 3D Bunion Correction® procedure in the surgical
management of symptomatic hallux valgus. The study will evaluate
for consistent and reliable correction of all three dimensions of
the bunion deformity with the Lapiplasty® Procedure, as well as
maintenance of such correction following accelerated return to
weight-bearing, initially in a walking boot. The primary
effectiveness endpoint is radiographic recurrence of the hallux
valgus deformity at 24 months follow-up. Key secondary endpoints
include change in three-dimensional radiographic alignment;
clinical radiographic healing; time to start of weight-bearing in a
boot and in shoes; pain; quality of life; and range of motion of
the big toe joint. The study enrolled 173 patients, aged 14 to 58
years, at 7 clinical sites in the United States with 13
participating surgeons. Final patient follow-up for the primary
endpoint was completed in the first half of 2023.
About Treace Medical
Concepts
Treace Medical Concepts, Inc. is a medical
technology company with the goal of advancing the standard of care
for the surgical management of bunion and related midfoot
deformities. Bunions are complex 3-dimensional deformities that
originate from an unstable joint in the middle of the foot and
affect approximately 65 million Americans, of which Treace
estimates 1.1 million are annual surgical candidates. Treace has
pioneered and patented the Lapiplasty® 3D Bunion Correction® System
– a combination of instruments, implants, and surgical methods
designed to surgically correct all 3 planes of the bunion deformity
and secure the unstable joint, addressing the root cause of the
bunion and helping patients get back to their active lifestyles.
Treace expanded its offering with the Adductoplasty® Midfoot
Correction System, designed for reproducible surgical correction of
the midfoot to provide further support to hallux valgus patients.
For more information, please visit www.treace.com.
To learn more about Treace, connect with us on
LinkedIn, Twitter, Facebook and Instagram.
Contacts:
Treace Medical Concepts,
Inc.Julie Dewey, IRCChief Communications & IR
Officerjddewey@treace.com | 209-613-6945
Treace Medical Concepts (NASDAQ:TMCI)
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