Treace Announces Interim Results from ALIGN3D™ Clinical Study at ACFAS 2021
May 19 2021 - 1:30PM
Treace Medical Concepts, Inc. (“Treace”) (Nasdaq: TMCI), a
commercial-stage orthopaedic medical device company driving a
paradigm shift in the surgical treatment of Hallux Valgus (commonly
known as bunions) through its Lapiplasty® 3D Bunion Correction™
procedure, today announced positive interim results from the
ALIGN3D™ clinical study in a podium presentation at the ongoing
American College of Foot and Ankle Surgeons (ACFAS) Annual
Scientific Conference.
Dr. George T. Liu, Associate Professor of
Orthopaedic Surgery at UT Southwestern Medical Center, and ALIGN3D™
participating surgeon presented the Interim Analysis of a Five-Year
Prospective Multicenter Study Assessing Radiographic and Patient
Reported Outcomes Following Triplanar Tarsometatarsal Arthrodesis
with Early Weightbearing. Data on the 128 study participants
included in the interim analysis demonstrated:
- Early return to
weightbearing in a walking boot at an average of 8.3 days;
- Significant
improvements in radiographic measurements of 3-dimensional bunion
correction (hallux valgus angle, intermetatarsal angle, and tibial
sesamoid position);
- 1.4% recurrence
rate observed (1 out of 72 patients) at 12 months post-surgery;
and
- Significant
improvements in patient-reported pain reduction and quality of life
measurements at 6 months, which were maintained at 12 months post
procedure.
“This interim data showed consistent, positive
radiographic and patient-reported outcomes starting at 6 weeks and
maintained at 12 months. Time to weightbearing of approximately 8
days in a walking boot compares favorably with up to 6-8 weeks,
often in a cast, associated with traditional Lapidus fusion.1 With
enrollment in the ALIGN3D™ study now completed, we look forward to
reporting on longer-term results in the future,” stated Dane
Wukich, MD, Professor and Chairman, Department of Orthopaedic
Surgery at the UT Southwestern Medical Center and the study’s lead
principal investigator.
John T. Treace, CEO of Treace commented, “The
Lapiplasty® 3D Bunion Correction™ system was developed to provide
surgeons the tools and surgical methods to reliably correct all 3
dimensions of the bunion deformity and address its root cause.
ALIGN3D™ is a unique and comprehensive 5-year study, and we are
pleased to report these positive interim results. We look forward
to continuing to build our robust portfolio of clinical evidence,
as we advance the standard of care for bunion surgery with our
proprietary Lapiplasty® procedure.”___________________________
1Catanzariti AR, et al. J Foot Ankle Surgery,
38:325-32 and Park CH, Ahn JY, Kim YM, Lee WC. Int
Orthop. 2013 Jun;37(6):1085-92.
About the ALIGN3D™ Clinical StudyThe ALIGN3D™
clinical study is a prospective, multicenter, post-market study
designed to evaluate outcomes of Lapiplasty® 3D Bunion Correction™
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 is anticipated in the first half of 2023.
About ACFAS Scientific ConferenceThe American
College of Foot and Ankle Surgeons (ACFAS) is a professional
society of more than 7,800 foot and ankle surgeons. The annual
ACFAS Scientific Conference is an educational event gathering foot
and ankle surgeons worldwide.
About Treace Medical ConceptsTreace Medical
Concepts, Inc. is a commercial-stage orthopaedic medical device
company with the goal of advancing the standard of care for the
surgical management of bunion deformities. Bunions are complex
3-dimensional deformities that originate from an unstable joint in
the middle of the foot. Treace has pioneered and patented the
Lapiplasty® 3D Bunion Correction™ system - a combination of
instruments, implants, and surgical methods designed to correct all
3 planes of the bunion deformity and secure the unstable joint,
addressing the root cause of the bunion and getting patients back
to their feet quickly in a walking boot.
To learn more about the benefits and risks of
Lapiplasty® 3D Bunion Correction™, or find a Lapiplasty® surgeon in
your area, please visit: www.AlignMyToe.com or
www.treace.com/patients.
Contacts:Treace Medical
ConceptsMark L. HairChief Financial
Officermhair@treace.net(904) 373-5940
Investors:Gilmartin GroupLynn
Lewis or Vivian CervantesIR@treace.net
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