Treace to Announce Interim Results from ALIGN3D™ at ACFAS 2021
Treace Medical Concepts (TMCI) announced that interim results of its ALIGN3D™ clinical study will be presented at the ACFAS Scientific Conference on May 19, 2021. The study evaluates the effectiveness of the Lapiplasty® 3D Bunion Correction™ in treating hallux valgus, involving 173 patients across seven sites. Key endpoints include recurrence of the bunion deformity and patient-reported outcomes after two years. The final follow-up for primary endpoints is expected in the first half of 2023, indicating ongoing commitment to advancing surgical treatment standards.
- 173 patients enrolled at 7 clinical sites for the ALIGN3D™ study.
- Focus on innovative Lapiplasty® 3D Bunion Correction™ method addressing bunion deformities.
- Final patient follow-up for primary endpoint not expected until first half of 2023.
PONTE VEDRA, Fla., May 12, 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), today announced that interim results from its ALIGN3D™ clinical study will be presented at the upcoming American College of Foot and Ankle Surgeons (ACFAS) Scientific Conference.
On May 19, 2021 at the Latest in Foot Surgery Session, the Interim Analysis of a Five-Year Prospective Multicenter Study Assessing Radiographic and Patient Reported Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing, will be presented by Dr. George T. Liu of UT Southwestern Medical Center.
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. 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 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.
About Treace Medical Concepts
Treace Medical Concepts 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.
To learn more about 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 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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