Treace Announces Peer-Reviewed Publication of Four-Year Results of the ALIGN3D™ Lapiplasty® Multicenter Prospective Clinical Study
Treace Medical Concepts (NASDAQ:TMCI), a medical technology company specializing in bunion surgery solutions, has published four-year interim results from its ALIGN3D™ multicenter prospective study in the Journal of Foot & Ankle Surgery. The study, which followed 139 of 173 patients, demonstrated strong outcomes for the Lapiplasty® Procedure.
Key findings include an early return to protected weight bearing at 7.7 days, transition to athletic shoes at 6.5 weeks, and notably low recurrence rates of 0.8% using HVA>20° and 8.4% using HVA>15° at 48 months. Patient outcomes showed significant improvements, with an 81% reduction in pain and 89% improvement in walking/standing capabilities through the 48-month period.
Treace Medical Concepts (NASDAQ:TMCI), azienda tecnologica medica specializzata in soluzioni per la chirurgia delle alluce valgo, ha pubblicato i risultati intermedi a quattro anni del suo studio prospettico multicentrico ALIGN3D™ sulla rivista Journal of Foot & Ankle Surgery. Lo studio, che ha seguito 139 pazienti su 173, ha evidenziato risultati molto positivi per la procedura Lapiplasty®.
I risultati principali includono un ritorno precoce al carico protetto in 7,7 giorni, il passaggio alle scarpe sportive a 6,5 settimane e, in modo significativo, bassi tassi di recidiva dello 0,8% con HVA>20° e dell'8,4% con HVA>15° a 48 mesi. Gli esiti per i pazienti hanno mostrato miglioramenti significativi, con una riduzione del dolore dell'81% e un miglioramento dell'89% nella capacità di camminare e stare in piedi durante il periodo di 48 mesi.
Treace Medical Concepts (NASDAQ:TMCI), una empresa de tecnología médica especializada en soluciones para cirugía de juanetes, ha publicado resultados intermedios a cuatro años de su estudio prospectivo multicéntrico ALIGN3D™ en el Journal of Foot & Ankle Surgery. El estudio, que siguió a 139 de 173 pacientes, mostró resultados sólidos para el Procedimiento Lapiplasty®.
Los hallazgos clave incluyen un retorno temprano a la carga protegida en 7,7 días, la transición a calzado deportivo a las 6,5 semanas y, notablemente, bajas tasas de recurrencia del 0,8% usando HVA>20° y 8,4% usando HVA>15° a los 48 meses. Los resultados en los pacientes mostraron mejoras significativas, con una reducción del dolor del 81% y una mejora del 89% en la capacidad para caminar y estar de pie durante el período de 48 meses.
Treace Medical Concepts (NASDAQ:TMCI)는 무지외반증 수술 솔루션을 전문으로 하는 의료기술 회사로, Journal of Foot & Ankle Surgery에 ALIGN3D™ 다기관 전향적 연구의 4년 중간 결과를 발표했습니다. 총 173명 중 139명의 환자를 추적한 이 연구는 Lapiplasty® 시술의 우수한 결과를 입증했습니다.
주요 결과로는 7.7일 만에 보호 하중으로의 조기 복귀, 6.5주에 운동화 착용 전환, 그리고 48개월 시점에 HVA>20° 기준으로 재발률 0.8%, HVA>15° 기준으로 8.4%의 낮은 재발률을 보였습니다. 환자 결과는 통증이 81% 감소하고, 걷기/서기 능력이 89% 향상되는 등 48개월 동안 유의미한 개선을 나타냈습니다.
Treace Medical Concepts (NASDAQ:TMCI), une entreprise de technologie médicale spécialisée dans les solutions chirurgicales pour l'oignon du pied, a publié les résultats intermédiaires sur quatre ans de son étude prospective multicentrique ALIGN3D™ dans le Journal of Foot & Ankle Surgery. L'étude, qui a suivi 139 patients sur 173, a démontré d'excellents résultats pour la procédure Lapiplasty®.
Les résultats clés incluent un retour précoce à la mise en charge protégée en 7,7 jours, la transition vers des chaussures de sport à 6,5 semaines, et surtout des faibles taux de récidive de 0,8% avec un HVA>20° et de 8,4% avec un HVA>15° à 48 mois. Les résultats des patients ont montré des améliorations significatives, avec une réduction de la douleur de 81% et une amélioration de 89% des capacités de marche et de station debout sur la période de 48 mois.
Treace Medical Concepts (NASDAQ:TMCI), ein Medizintechnikunternehmen, das sich auf Lösungen für die Hallux-valgus-Chirurgie spezialisiert hat, hat Zwischenergebnisse über vier Jahre aus seiner prospektiven multizentrischen ALIGN3D™-Studie im Journal of Foot & Ankle Surgery veröffentlicht. Die Studie, die 139 von 173 Patienten verfolgte, zeigte starke Ergebnisse für das Lapiplasty®-Verfahren.
Wesentliche Erkenntnisse umfassen eine frühe Rückkehr zur geschützten Belastung nach 7,7 Tagen, den Übergang zu Sportschuhen nach 6,5 Wochen und bemerkenswert niedrige Rückfallraten von 0,8% bei HVA>20° und 8,4% bei HVA>15° nach 48 Monaten. Die Patientenergebnisse zeigten signifikante Verbesserungen mit einer 81%igen Schmerzlinderung und einer 89%igen Verbesserung der Geh- und Stehfähigkeit über den Zeitraum von 48 Monaten.
- Low radiographic recurrence rates of 0.8% using HVA>20° at 48 months
- Significant patient improvements with 81% pain reduction and 89% walking/standing improvement
- Quick recovery with weight bearing at 7.7 days and return to athletic shoes at 6.5 weeks
- Results demonstrate sustained successful outcomes over a long-term 4-year period
- None.
Insights
Treace's Lapiplasty shows strong 4-year clinical results with very low recurrence rates, validating their bunion correction approach.
The publication of four-year interim results from Treace's ALIGN3D multicenter prospective study represents significant clinical validation for their Lapiplasty Procedure. The data demonstrates remarkably low recurrence rates of just
What makes these results particularly compelling is the durability of correction. Bunion recurrence is a well-known challenge with traditional osteotomy procedures, often requiring revision surgeries. The study also documents impressive functional improvements with an
From a clinical adoption perspective, the early weight-bearing data (average 7.7 days) and return to athletic shoes (6.5 weeks) addresses a key patient concern about recovery time. The robust sample size of 139 patients with four-year follow-up from the original 173 participants provides statistical credibility to these findings.
This peer-reviewed publication in the Journal of Foot & Ankle Surgery establishes a substantial evidence base that Treace can leverage to drive physician education and adoption. For medical technology companies, this level of clinical validation is often a critical inflection point that helps transition a procedure from novel technology to standard of care, particularly when published in respected specialty journals with long-term data.
PONTE VEDRA, Fla., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities, today announced the peer-reviewed publication of the four-year interim results from its ALIGN3D™ multicenter prospective study demonstrating positive clinical and radiographic outcomes of the Lapiplasty® Procedure in the Journal of Foot & Ankle Surgery.
The published results entitled, “Four-Year Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing for Hallux Valgus: A Multicenter Prospective Study” include interim data on 139 of 173 study patients treated with at least four years of follow-up from Lapiplasty® in the prospective, five-year, multicenter ALIGN3D™ clinical study. The data showed:
- Early return to protected weight bearing at an average of 7.7 days and return to athletic shoes at 6.5 weeks;
- Low radiographic recurrence rates of
0.8% using HVA>20° and8.4% using HVA>15° at 48 months; and - Continued significant improvement in pain and patient-reported outcome scores (VAS, MOxFQ and PROMIS), including an
81% improvement in pain and89% improvement in walking/standing on the MOxFQ scoring system through 48 months.
John T. Treace, CEO, Founder and Chairman of Treace said, “We are pleased to announce this new peer-reviewed publication from our flagship ALIGN3D™ study demonstrating sustained, successful patient outcomes from our proprietary Lapiplasty® Procedure out to four years. This long-term, multicenter, prospective study sets a high standard for a commercial bunion technology and further differentiates Lapiplasty® in the marketplace with surgeons and patients. We look forward to expanding our market-leading body of clinical evidence as we continue to focus on advancing the standard of care for bunion surgery.”
“These interim results from the ALIGN3D™ study showed consistent, positive radiographic and patient-reported outcomes maintained at four years,” stated Daniel Hatch, DPM, of the Foot and Ankle Center of the Rockies in Greeley, Colorado and publication author.¹ “Importantly, by consistently performing a comprehensive 3D correction of the bunion deformity, the recurrence rates with the Lapiplasty® Procedure are very low and compare favorably to long-term studies of traditional osteotomy with high rates of recurrence.2”
The full publication, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the studies, is available on the Journal of Foot & Ankle Surgery website https://www.jfas.org/article/S1067-2516(25)00210-8/fulltext.
About the ALIGN3D™ Clinical Study
The ALIGN3D™ clinical study is a prospective, multicenter, post-market clinical study designed to evaluate outcomes of the Lapiplasty® 3D Bunion Correction® procedure in the surgical management of symptomatic hallux valgus. The study evaluates consistency and reliability of 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. 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 was completed in the first half of 2023, and study completion with 5-year data is expected in 2026.
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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 three 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. To further support the needs of surgeons and bunion patients, Treace offers its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, two systems for minimally invasive osteotomy procedures, namely the Nanoplasty® 3D Minimally Invasive Bunion Correction System and the Percuplasty™ Percutaneous 3D Bunion Correction System, as well as the SpeedMTP® MTP Fusion System. Treace continues to expand its footprint in the marketplace by extending its SpeedPlate® rapid compression implant platform to new applications, as well as providing surgeons with advanced digital solutions with its IntelliGuide® patient specific, pre-op planning and cut guide technology. For more information, please visit www.treace.com.
To learn more about Treace, connect with us on LinkedIn, X, Facebook and Instagram.
1 Daniel Hatch, DPM is a member of Treace’s Surgeon Advisory Board and a paid consultant for Treace.
2 Lalevee M, et al. Recurrence Rates With Longer-Term Follow-up After Hallux Valgus Surgical Treatment With Distal Metatarsal Osteotomies: A Systematic Review and Meta-analysis. Foot & Ankle International. 2023;44:210-222.
Contacts:
Treace Medical Concepts
Mark L. Hair
Chief Financial Officer
mhair@treace.net
(904) 373-5940
Investors:
Gilmartin Group
Philip Trip Taylor
IR@treace.net
FAQ
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