Treace Announces New Supportive ALIGN3D™ Data to be Presented at the 2021 AOFAS Annual Meeting
Treace Medical Concepts (Nasdaq: TMCI), a pioneering orthopaedic medical device company, announced new data will be presented at the 2021 AOFAS Annual Meeting on September 22-25. The presentation will feature an interim analysis from the ALIGN3D™ clinical study, which evaluates the Lapiplasty® 3D Bunion Correction™ procedure. Lead author Dr. Dane Wukich will discuss outcomes from this multicenter study, focusing on patient recovery and radiographic results. The study aims to confirm effective bunion correction over a 24-month follow-up with 173 enrolled patients.
- New data presentation at a prominent medical conference (AOFAS) showcasing clinical study results.
- ALIGN3D™ study involves 173 patients, enhancing credibility of results.
- Focus on effective correction and maintenance of bunion deformity over 24-month follow-up.
- Final patient follow-up for primary endpoint not expected until the first half of 2023, delaying potential market impact.
- Interim results may not fully represent final outcomes, leading to uncertainty.
PONTE VEDRA, Fla., Sept. 01, 2021 (GLOBE NEWSWIRE) -- 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 Meeting
The 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 Concepts
Mark L. Hair
Chief Financial Officer
mhair@treace.net
(904) 373-5940
Investors:
Gilmartin Group
Lynn Lewis or Vivian Cervantes
IR@treace.net
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