Treace Announces Updated ALIGN3D™ Data at the 2022 ACFAS Scientific Conference
Treace Medical Concepts (TMCI) has presented the latest interim analysis from the ALIGN3D clinical study at the 2022 ACFAS Annual Scientific Conference. The analysis included data from 160 participants, demonstrating a return to weight-bearing in 8.5 days and significant improvements in pain reduction and quality of life after 12 and 24 months following the Lapiplasty procedure. Notably, the recurrence rates were low at 0.9% and 0.0% at 12 and 24 months, respectively. CEO John T. Treace expressed commitment to advancing clinical evidence supporting their solutions for bunion patients.
- Early weight-bearing return average of 8.5 days.
- Significant pain reduction and improved quality of life after 12 and 24 months.
- Low recurrence rates of 0.9% at 12 months and 0.0% at 24 months.
- Return to work within 4 weeks and full activity within 4 months.
- None.
PONTE VEDRA, Fla., Feb. 25, 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 podium presentation of the latest interim analysis from the ALIGN3D™ clinical study at the ongoing 2022 American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference in Austin, Texas.
Updated results of “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” was presented at the podium. Data on 160 study participants showed:
- Early return to weight bearing in a walking boot at an average 8.5 days;
- Significant improvement in radiographic measures of 3-dimensional bunion correction and patient reported pain reduction and quality of life measurements at 12 months (n=119) and through 24 months (n=52) following the Lapiplasty® procedure;
- Return to work within 4 weeks and to full, unrestricted activity within 4 months of procedure on average; and
- Low recurrence rate maintained;
0.9% (1 out of 116 patients) and0.0% (0 out of 54 patients) recurrence rates observed at 12 months and 24 months post-surgery, respectively.
John T. Treace, CEO, Founder and Board Member of Treace said, “We are pleased to announce new ALIGN3D™ data on additional patients followed through 12- and 24-months post-surgery that continue to demonstrate sustained, successful procedural and patient outcomes from our proprietary Lapiplasty® System, specifically designed to address the unmet needs of bunion patients. We remain committed to growing a body of clinical evidence that supports our differentiated solution, as we advance the standard of care for bunion surgery.”
An abstract on the podium presentation can be accessed by meeting attendees through the ACFAS mobile app. The new data is also 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 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 which could 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
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