Treace to Announce Latest ALIGN3D™ Data at the 2022 ACFAS Scientific Conference

Rhea-AI Summary

Treace Medical Concepts (TMCI) announced the podium presentation of interim analysis data from its ALIGN3D™ clinical study at the ACFAS Annual Scientific Conference from February 24-27, 2022, in Austin, Texas. The presentation, led by Dr. George Tye Liu, will focus on a five-year multicenter study evaluating outcomes of the Lapiplasty® 3D Bunion Correction™. The study, involving 173 patients, aims to assess the effectiveness of correcting hallux valgus deformity with a focus on various clinical outcomes. Final follow-up for primary endpoints is expected in the first half of 2023.

Positive

• Presentation of interim analysis at a reputable conference could enhance visibility and credibility.
• Involvement of a respected expert (Dr. Liu) may provide further validation of the Lapiplasty® procedure.
• The ALIGN3D™ study is comprehensive, encompassing 173 patients across multiple sites, indicating robust data collection.

Negative

• Final patient follow-up for the primary endpoint is not anticipated until the first half of 2023, indicating a lengthy wait for conclusive results.
• Dependence on clinical outcomes for market acceptance may expose the company to risks if results are unfavorable.

PONTE VEDRA, Fla., Feb. 01, 2022 (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 podium presentation of the latest interim analysis from the ALIGN3D™ clinical study at the 2022 American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference to be held in February 24-27 in Austin, Texas.

George Tye Liu, DPM, Associate Professor of Orthopaedic Surgery at UT Southwestern Medical Center and ALIGN3D™ participating surgeon, will be presenting “One- and Two-Year Analysis of a Five-Year Prospective Multicenter Study Assessing Radiographic and Patient Reported Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing” at the ACFAS scientific conference on Friday, February 25 at 11:08am CST. An abstract on the podium presentation can be accessed by meeting attendees through the ACFAS mobile app once the conference begins on February 24. 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 walking 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 and related midfoot correction. 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 helping patients get back to their active lifestyles. Treace recently expanded its offering with the Adductoplasty™ Midfoot Correction System, designed for reproducible correction of the midfoot to provide further support to hallux valgus patients. For more information, please visit www.treace.com.

About ACFAS Scientific Conference

The 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.

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

FAQ

What is the ALIGN3D™ clinical study related to TMCI?

The ALIGN3D™ clinical study evaluates the outcomes of the Lapiplasty® 3D Bunion Correction™ for managing hallux valgus.

When will the ALIGN3D™ study results be presented?

The interim analysis results will be presented at the ACFAS Annual Scientific Conference from February 24-27, 2022.

Who is presenting the ALIGN3D™ study data?

Dr. George Tye Liu will present the study's data at the conference.

How many patients are involved in the ALIGN3D™ clinical study?

The study includes 173 patients across seven clinical sites in the United States.

When is the final follow-up for the ALIGN3D™ study expected?

Final follow-up for the primary endpoint is anticipated in the first half of 2023.