Treace Announces New Supportive ALIGN3D™ Data to be Presented at the 2021 AOFAS Annual Meeting
September 01 2021 - 10:00AM
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 the upcoming presentation of new data at
the 2021 American Orthopaedic Foot & Ankle Society (AOFAS)
Annual Meeting to be held September 22-25 in Charlotte, North
Carolina. The presentation describes the interim analysis from the
ALIGN3D™ clinical study.
Dane Wukich, MD, Professor and Chair of the
Department of Orthopaedic Surgery at the University of Texas,
Southwestern, is the lead author of, and will be presenting,
“Results of an Interim Analysis of a Prospective Multicenter Study
Assessing Radiographic and Patient Outcomes Following Triplanar
Tarsometatarsal Arthrodesis with Early Weightbearing” at the AOFAS
meeting. A poster summarizing the data and conclusions can be
accessed by meeting attendees through the AOFAS mobile app once the
conference begins on September 22, 2021. The new data will also be
made available on the Treace Medical website.
About the ALIGN3D™ Clinical Study The
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 Treace Medical Concepts Treace
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 active lives quickly.
About AOFAS Annual MeetingThe American
Orthopaedic Foot & Ankle Society® (AOFAS) mobilizes its global
community of foot and ankle orthopaedic specialists to improve
patient care through education, research, and advocacy. The AOFAS
Annual Meeting is the premier event for foot and ankle education,
offering presentations from renowned speakers, special interest
forums, social events, and the latest products and technology.
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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