Treace Presents Updated ALIGN3D™ Interim Data and Latest Product Innovations at the 2023 ACFAS Annual Conference

Rhea-AI Summary

Treace Medical Concepts (NasdaqGS: TMCI) announced the latest interim clinical data from its ALIGN3D™ study during the 2023 ACFAS Annual Conference. The study analyzed 128 patients, revealing a remarkable 99.1% maintenance of bunion correction at 24 months and only a 0.9% recurrence rate. Patients experienced an average return to weight-bearing in just 8.1 days, with an 80.8% reduction in pain at 24 months. High satisfaction rates were reported, with 97.3% of patients satisfied at 36 months. Treace also showcased innovations like the Micro-Lapiplasty™ and SpeedPlate™ systems, set for commercialization later this year.

Positive

• 99.1% maintenance of correction in bunion surgery after 24 months.
• 0.9% recurrence rate of bunions at 24 months.
• Average return to weight-bearing in just 8.1 days.
• 80.8% pain reduction at 24 months.
• 97.3% patient satisfaction at 36 months.

Negative

• None.

PONTE VEDRA, Fla., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of hallux valgus (commonly known as bunions) through its Lapiplasty® 3D Bunion Correction™ procedure today announced it will highlight new interim clinical data from the ALIGN3D™ study, and recent product innovations, at the 2023 American College of Foot and Ankle Surgeons (“ACFAS”) Annual Scientific Conference in Los Angeles, California.

The scientific poster titled, “Three Year Interim Analysis of a Five-Year Multicenter Study Assessing Radiographic and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing”,¹ includes an interim analysis of 128 patients from the ALIGN3D™ study with at least 24 months of follow-up following the Lapiplasty® Procedure demonstrating:

• Early return to weight bearing in a walking boot at an average 8.1 days;
• 99.1% maintenance of correction in radiographic measures of 3-dimensional bunion correction at 24 months (n=118) and a recurrence rate of 0.9%²
• 80.8% reduction in pain measured using the Visual Analog Scale (“VAS”) at 24 months (n=128);
• 92% and 90% improvement in walking/standing and social interaction patient-reported quality of life measures, respectively, using the Manchester-Oxford Foot Questionnaire (MOxFQ) through 36 months (n=41); and
• 97.3% of patients reporting they were satisfied or very satisfied with overall results of the procedure at 36 months (n=37).
  
  

John T. Treace, CEO, Founder and Board Member of Treace, said, “We are excited by the updated interim results from our ALIGN3D™ study showing high patient satisfaction with rapid return to weightbearing, low recurrence rates, and significant reduction in pain and patient reported outcome scores at 24 months following the Lapiplasty® procedure. As a company focused on improving surgical outcomes for bunion patients, we are committed to reporting the long-term results of our novel Lapiplasty® procedure though this unique 5-year, multicenter study.”

During the ACFAS Conference, Treace will feature its current and next-generation technologies at its exhibit booth including the Micro-Lapiplasty™ and SpeedPlate™ systems, which are expected to commercialize later this year. The Company will also be hosting Lapiplasty® and Adductoplasty® surgeon hands-on training labs featuring recently commercialized innovations, including the Lapiplasty® 3-n-1™ Guide, Lapiplasty® S4A Anatomic Plating Kit, and the SpeedRelease™ and TriTome™ tissue release instruments.

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 medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 65 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patented the Lapiplasty® 3D Bunion Correction™ System – a combination of instruments, implants, and surgical methods designed to surgically 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 expanded its offering with the Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of the midfoot to provide further support to hallux valgus patients. For more information, please visit www.treace.com.

About ACFAS Annual Conference

The American College of Foot and Ankle Surgeons 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.

1. The ACFAS Scientific Poster, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the study, will be accessible on Treace Medical’s Website at: https://www.lapiplasty.com/surgeons/journal-publications/.
2. 0.9% of patients (1 out of 114 patients) demonstrated radiographic recurrence at 24 month follow up timepoint. 1.4% of patients (2 out of 144 patients) demonstrated radiographic recurrence at 12 month follow up timepoint.

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 were the key findings from Treace Medical's ALIGN3D study presented at the 2023 ACFAS conference?

The ALIGN3D study found a 99.1% maintenance of bunion correction and a 0.9% recurrence rate at 24 months.

What is the timeline for Treace Medical's new products?

Treace expects to commercialize the Micro-Lapiplasty™ and SpeedPlate™ systems later in 2023.

What level of patient satisfaction was reported in the ALIGN3D study?

97.3% of patients reported being satisfied or very satisfied with the overall results at 36 months.

How quickly can patients return to weight-bearing after the Lapiplasty procedure?

Patients typically return to weight-bearing in an average of 8.1 days post-surgery.

What was the reduction in pain reported by patients after 24 months?

Patients reported an 80.8% reduction in pain as measured by the Visual Analog Scale.