Treace Medical Concepts, Inc. (“Treace” or the “Company”)
(NasdaqGS: TMCI), a medical technology company driving a
fundamental shift in the surgical treatment of bunions and related
midfoot deformities through its flagship Lapiplasty® and
Adductoplasty® Procedures, today announced three-year interim
clinical data from its ALIGN3D™ post-market study supporting the
use of the Lapiplasty® procedure for treating bunions were
presented in a podium presentation at the 2024 American College of
Foot and Ankle Surgeons (“ACFAS”) Annual Scientific Conference.
“This interim data from the ALIGN3D™ study
showed consistent, positive radiographic and patient-reported
outcomes maintained at three years,” stated Daniel Hatch, DPM, of
the Foot and Ankle Center of the Rockies in Greeley, Colorado and
presenting surgeon.¹ “Importantly, by providing a comprehensive, 3D
correction of the bunion deformity, study participants were able to
quickly return to protected weightbearing in approximately eight
days and get back to their active lifestyle with a low rate of
clinical complications and recurrence.”
“We are pleased that this three-year data from
our prospective, multicenter ALIGN3D™ study continues to
demonstrate sustained, successful patient outcomes from our
proprietary Lapiplasty® Procedure,” said John T. Treace, CEO,
Founder and Board Member of Treace. “We believe these three-year
clinical study results set a high standard for a commercial bunion
technology and one that further differentiates Lapiplasty® in the
marketplace with our surgeons and their patients. We look forward
to continuing to expand our market-leading body of clinical
evidence, as we advance the standard of care for bunion
surgery.”
ALIGN3D™ Clinical Study
The scientific presentation, titled “Three-Year
Analyses of a Five-Year Prospective Multicenter Study Assessing
Radiographic and Patient Reported Outcomes Following Triplanar
Tarsometatarsal Arthrodesis with Early Weightbearing,” featured
interim data from the prospective, five-year, multicenter ALIGN3D™
clinical study with 173 enrolled patients and demonstrated positive
results following the Lapiplasty® Procedure, which
included:
-
Early return to weight bearing in a walking boot at an average 8.4
days;
-
Low radiographic recurrence rates at latest visit of 0.9% using
HVA>20° (1 out of 115) and 5.2% using HVA>15° (6 out of
115);
-
81% reduction in pain measured using the Visual Analog Scale
(“VAS”) at 24 months (n=156);
-
86% and 85% improvement in walking/standing and social interaction
patient-reported quality of life measures, respectively, using the
Manchester-Oxford Foot Questionnaire (“MOxFQ”) through latest
subject visit [mean 40.5 months (n=118)];
-
Significant improvement in patient reported outcomes across all
Patient-Reported Outcomes Measurement Information System (“PROMIS”)
domains over time through latest subject visit [mean 40.5 months
(n=113)]; and
-
Low symptomatic non-union rate of 1.8% (3 out of 173).
The ALIGN3D™ study is ongoing, and patients are
expected to be followed for five years. The Company has submitted
its primary endpoint ALIGN3D™ manuscript to a top-tier,
peer-reviewed foot and ankle journal at the end of 2023 and expects
publication in 2024.
Mini3D™ Clinical Study
In addition to the ALIGN3D™ data, interim data
from the Company’s Mini3D™ prospective, multicenter study was
presented in a poster presentation at ACFAS titled “Interim
Analysis of a Prospective Multicenter Study Assessing Radiographic
and Patient Outcomes Following a Mini-Open Triplanar
Tarsometatarsal Arthrodesis with Early Weightbearing.” This
poster presentation included data from 103 enrolled patients and
demonstrated favorable clinical and patient-reported outcomes with
a mini-incision approach (median incision length: 3.5cm) at an
average follow-up time of 7.4 months post-procedure, including:
- Early return to weight-bearing in a walking boot at an average
7.8 days;
- Maintenance of radiographic correction (IMA, HVA, TSP) through
12 months;
- Significant reduction in pain (VAS) and significant improvement
in patient reported outcomes (MOxFQ) through 12 months; and
- Favorable scores for scar quality using the Patient and
Observer Scar Assessment Scale (“POSAS”).
Both ACFAS presentations, which include
additional details such as patient demographics,
inclusion/exclusion criteria, and complications reported in the
studies, are available on Treace’s website
at www.lapiplasty.com/surgeons/journal-publications/.
More information on Treace’s products can be found at
www.lapiplasty.com.
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; patient-reported quality of life measures;
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 the Mini3D™ Clinical
Study
The Mini3D™ clinical study is a prospective,
multicenter, post-market study designed to evaluate the ability of
the Lapiplasty® Mini-Incision™ Procedure to consistently
and reliably correct all three dimensions of the bunion deformity
and maintain the correction following accelerated return to
weight-bearing. The study’s primary endpoint is radiographic
recurrence of the bunion deformity at 24 months follow up.
Secondary endpoints include changes in three-dimensional
radiographic alignment; clinical radiographic healing; time to
start of weight-bearing in a boot and in shoes; pain; quality of
life; range of motion of the big toe joint; change, if any, in the
initial incision length and scar quality; change in radiographic
foot length and width as well as swelling; and any correlation
between the amount of time an external positioner is actively used
during the procedure with necrosis, blistering, bruising, and
tissue ulceration. The study is scheduled to enroll 105 patients,
aged 14 to 58 years, at 9 clinical sites in the United States with
9 participating surgeons.
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 expectations for publication of the
primary endpoint ALIGN3D™ manuscript in 2024. 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 its subsequent SEC filings. 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 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 67 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. To further support the needs of bunion patients,
Treace has introduced its Adductoplasty® Midfoot Correction
System, designed for reproducible surgical correction of the
midfoot as well as its Hammertoe PEEK Fixation System designed to
address hammertoe, claw toe and mallet toe deformities. The company
continues to expand its footprint in the foot and ankle market with
the introduction of its SpeedPlate™ Rapid Compression
Implants, an innovative fixation platform with broad versatility
across Lapiplasty® and Adductoplasty® procedures, as well
as other common bone fusion procedures of the foot. For more
information, please visit www.treace.com.
To learn more about Treace, connect with us on
LinkedIn, Twitter, Facebook and Instagram.
¹ Daniel Hatch, DPM is a member of Treace’s
Surgeon Advisory Board and a paid consultant for Treace.
Contacts:
Treace Medical Concepts,
Inc.Julie Dewey, IRCChief Communications & Investor
Relations Officerjddewey@treace.com | 209-613-6945
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