Treace Announces Clinical Study Data Demonstrating Positive Lapiplasty® and Adductoplasty® Outcomes at the 2025 ACFAS Annual Scientific Conference
Treace Medical Concepts (NASDAQ: TMCI) presented updated clinical data for its bunion and midfoot deformity treatments at the 2025 ACFAS Conference. The company showcased results from three key studies:
The ALIGN3D™ study (135 patients, 4-year follow-up) showed early weight bearing at 8.4 days and low recurrence rates of 0.8% (HVA>20°). The Mini3D™ study (75 patients, 1-year follow-up) demonstrated weight bearing at 7.9 days with 0% recurrence (HVA>20°). The MTA3D™ study (18 patients, 1-year follow-up) reported weight bearing at 7.5 days with significant improvements in both midfoot and bunion deformity correction.
All studies showed significant improvements in pain and patient-reported outcomes. Additional retrospective data from 43 patients undergoing Adductoplasty® and Lapiplasty® procedures showed positive clinical results over a 17.7-month follow-up period.
Treace Medical Concepts (NASDAQ: TMCI) ha presentato dati clinici aggiornati per i suoi trattamenti per alluce valgo e deformità del mesopiede durante la Conferenza ACFAS 2025. L'azienda ha mostrato i risultati di tre studi chiave:
Lo studio ALIGN3D™ (135 pazienti, follow-up di 4 anni) ha mostrato un carico precoce a 8,4 giorni e tassi di recidiva bassi dello 0,8% (HVA>20°). Lo studio Mini3D™ (75 pazienti, follow-up di 1 anno) ha dimostrato un carico a 7,9 giorni con 0% di recidiva (HVA>20°). Lo studio MTA3D™ (18 pazienti, follow-up di 1 anno) ha riportato un carico a 7,5 giorni con miglioramenti significativi sia nella correzione delle deformità del mesopiede che dell'alluce valgo.
Tutti gli studi hanno mostrato miglioramenti significativi nel dolore e nei risultati riportati dai pazienti. Dati retrospettivi aggiuntivi da 43 pazienti sottoposti a procedure di Adductoplasty® e Lapiplasty® hanno mostrato risultati clinici positivi su un periodo di follow-up di 17,7 mesi.
Treace Medical Concepts (NASDAQ: TMCI) presentó datos clínicos actualizados para sus tratamientos de juanetes y deformidades del mediopié en la Conferencia ACFAS 2025. La compañía mostró los resultados de tres estudios clave:
El estudio ALIGN3D™ (135 pacientes, seguimiento de 4 años) mostró una carga temprana a los 8,4 días y tasas de recurrencia bajas del 0,8% (HVA>20°). El estudio Mini3D™ (75 pacientes, seguimiento de 1 año) demostró carga a los 7,9 días con 0% de recurrencia (HVA>20°). El estudio MTA3D™ (18 pacientes, seguimiento de 1 año) reportó carga a los 7,5 días con mejoras significativas tanto en la corrección de deformidades del mediopié como de juanetes.
Todos los estudios mostraron mejoras significativas en el dolor y en los resultados reportados por los pacientes. Datos retrospectivos adicionales de 43 pacientes sometidos a procedimientos de Adductoplasty® y Lapiplasty® mostraron resultados clínicos positivos durante un período de seguimiento de 17,7 meses.
Treace Medical Concepts (NASDAQ: TMCI)는 2025 ACFAS 컨퍼런스에서 무지외반증 및 중족골 변형 치료를 위한 업데이트된 임상 데이터를 발표했습니다. 이 회사는 세 가지 주요 연구 결과를 선보였습니다:
ALIGN3D™ 연구 (135명 환자, 4년 추적 관찰)는 8.4일에 조기 체중 부하를 보여주었고, 0.8% (HVA>20°)의 낮은 재발률을 기록했습니다. Mini3D™ 연구 (75명 환자, 1년 추적 관찰)는 7.9일에 체중 부하를 보여주었고, 재발률은 0% (HVA>20°)였습니다. MTA3D™ 연구 (18명 환자, 1년 추적 관찰)는 7.5일에 체중 부하를 보고했으며, 중족골 및 무지외반증 교정에서 유의미한 개선을 보였습니다.
모든 연구는 통증 및 환자가 보고한 결과에서 유의미한 개선을 보여주었습니다. Adductoplasty® 및 Lapiplasty® 절차를 받은 43명의 환자로부터의 추가적인 회고적 데이터는 17.7개월의 추적 관찰 기간 동안 긍정적인 임상 결과를 보여주었습니다.
Treace Medical Concepts (NASDAQ: TMCI) a présenté des données cliniques mises à jour pour ses traitements des oignons et des déformations du médio-pied lors de la Conférence ACFAS 2025. L'entreprise a mis en avant les résultats de trois études clés :
L'étude ALIGN3D™ (135 patients, suivi de 4 ans) a montré une charge précoce à 8,4 jours et des taux de récidive faibles de 0,8% (HVA>20°). L'étude Mini3D™ (75 patients, suivi de 1 an) a démontré une charge à 7,9 jours avec 0% de récidive (HVA>20°). L'étude MTA3D™ (18 patients, suivi de 1 an) a rapporté une charge à 7,5 jours avec des améliorations significatives tant dans la correction des déformations du médio-pied que des oignons.
Toutes les études ont montré des améliorations significatives de la douleur et des résultats rapportés par les patients. Des données rétrospectives supplémentaires provenant de 43 patients ayant subi des procédures d'Adductoplasty® et de Lapiplasty® ont montré des résultats cliniques positifs sur une période de suivi de 17,7 mois.
Treace Medical Concepts (NASDAQ: TMCI) präsentierte aktualisierte klinische Daten zu seinen Behandlungen von Hallux valgus und Mittelfußdeformitäten auf der ACFAS-Konferenz 2025. Das Unternehmen stellte die Ergebnisse von drei wichtigen Studien vor:
Die ALIGN3D™-Studie (135 Patienten, 4 Jahre Nachbeobachtung) zeigte eine frühe Belastung nach 8,4 Tagen und eine niedrige Rückfallrate von 0,8% (HVA>20°). Die Mini3D™-Studie (75 Patienten, 1 Jahr Nachbeobachtung) demonstrierte eine Belastung nach 7,9 Tagen mit 0% Rückfall (HVA>20°). Die MTA3D™-Studie (18 Patienten, 1 Jahr Nachbeobachtung) berichtete von einer Belastung nach 7,5 Tagen mit signifikanten Verbesserungen sowohl bei der Korrektur von Mittelfuß- als auch Hallux valgus-Deformitäten.
Alle Studien zeigten signifikante Verbesserungen bei Schmerzen und von den Patienten berichteten Ergebnissen. Zusätzliche retrospektive Daten von 43 Patienten, die sich Adductoplasty®- und Lapiplasty®-Verfahren unterzogen, zeigten positive klinische Ergebnisse über einen Nachbeobachtungszeitraum von 17,7 Monaten.
- Zero recurrence rate (0%) in Mini3D study at 12 months using HVA>20°
- Extremely low recurrence rate (0.8%) in ALIGN3D study at 48 months using HVA>20°
- Consistent early return to weight bearing across all procedures (7.5-8.4 days)
- Significant improvements in pain and patient-reported outcomes across all studies
- Higher recurrence rate (7.7%) when using stricter HVA>15° criterion in ALIGN3D study
- sample size in MTA3D study with only 18 patients at one-year follow-up
Insights
Treace's presentation of multiple positive clinical datasets at the ACFAS conference represents significant clinical validation for their flagship Lapiplasty® and Adductoplasty® procedures. The ALIGN3D™ 4-year data demonstrates sustained correction with remarkably low recurrence rates of just 0.8% using the stricter HVA>20° criterion, addressing a key concern in bunion surgery. The Mini3D™ study shows comparable outcomes through smaller incisions, likely enhancing the procedure's appeal to both surgeons and patients.
Most notably, this conference marks the first presentation of MTA3D™ Adductoplasty® data, expanding Treace's addressable market into midfoot deformity correction. While this dataset is smaller (18 patients), it demonstrates the company's strategic expansion beyond their core bunion correction technology.
Consistent across all studies is the early return to weightbearing (7.5-8.4 days), a significant advantage over traditional approaches that often require weeks of immobilization. The patient-reported outcome improvements further validate these procedures from both clinical and quality-of-life perspectives.
This growing clinical evidence portfolio strengthens Treace's position with surgeons, patients, and potentially payers, as the company builds a comprehensive data foundation supporting their differentiated approach to bunion and midfoot deformity correction.
PONTE VEDRA, Fla., March 28, 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 through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced the presentation of updated interim data for the ALIGN3D™ and Mini3D™ Lapiplasty® clinical studies, as well as the first presentation of the MTA3D™ Adductoplasty® clinical study, at the 2025 American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting in Phoenix, Arizona.
“We are excited to feature our growing body of clinical data to surgeons attending the 2025 ACFAS conference,” stated John T. Treace, CEO, Founder and Board Member of Treace. “This builds on our commitment to support our flagship Lapiplasty® and Adductoplasty® procedures with clinical evidence and notably marks the first meeting where all three of our prospective, multicenter studies are presented, including our ALIGN3D™, Mini3D™, and MTA3D™ studies, demonstrating positive clinical outcomes and further differentiating these procedures with surgeons and patients.”
ALIGN3D™ Lapiplasty® Clinical Study Presentation
ALIGN3D™ clinical study results presented by Daniel Hatch, DPM (Foot & Ankle Center of the Rockies, Greeley, CO) on Friday, March 28 as a podium presentation entitled, “Four-Year Analysis of a Five-Year Prospective Multicenter Study Assessing Radiographic Recurrence and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing.” The featured interim data from the prospective, five-year, multicenter ALIGN3D™ clinical study of the Lapiplasty® Procedure included interim analysis of 135 of 173 patients treated with at least four years of follow-up. The data showed:
- Early return to protected weight bearing at an average 8.4 days;
- Low radiographic recurrence rates of
0.8% using HVA>20° and7.7% using HVA>15° at 48 months; and - Continued significant improvement in pain and patient-reported outcome scores (MOxFQ and PROMIS) at 48 months.
Mini3D™ Lapiplasty Mini-Incision™ Clinical Study Presentation
Mini3D™ clinical study results presented by Jody McAleer, DPM (Jefferson City Medical Group, Jefferson City, MO) on Friday, March 28 as a podium presentation entitled, “Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following an Instrumented Mini-Open Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing.” The featured results of this prospective, multicenter Mini3D™ clinical study of the Lapiplasty® Mini-Incision™ Procedure (median incision length: 3.5cm) included interim analysis of 75 of 105 patients treated with at least one year follow-up. The data showed:
- Early return to protected weightbearing at an average 7.9 days;
- Low radiographic recurrence rates of
0.0% using HVA>20° and5.5% using HVA>15° at 12 months; and - Significant improvements in pain and patient-reported scores (MOxFQ and PROMIS) at 12 months.
MTA3D™ Adductoplasty® Clinical Study Presentation
MTA3D™ clinical study results presented by Paul Dayton, DPM (Foot and Ankle Center of Iowa, Ankeny, IA) on Friday, March 28 as a poster presentation, entitled “Interim 1-Year Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient-Reported Outcomes Following Combined Metatarsus Adductus and Hallux Valgus Correction through 3rd, 2nd, and 1st Tarsometatarsal Arthrodesis with Early Weightbearing.” The featured interim data from the prospective, five-year, multicenter MTA3D™ clinical study of the patients undergoing both the Adductoplasty® and Lapiplasty® procedures included interim analysis of 18 of 38 patients treated with at least one year follow-up. The data showed:
- Early return to protected weightbearing at an average 7.5 days;
- Clinically significant improvement relative to baseline in radiographic measures of both midfoot (metatarsus adductus) and 3D bunion deformity correction at 12 months; and
- Clinically significant reduction in pain and patient-reported scores (MOxFQ and PROMIS) at 12 months.
Additionally, results from a retrospective study on the Adductoplasty® Procedure were presented by Jody McAleer, DPM (Jefferson City Medical Group, Jefferson City, MO) on Friday, March 28 as a podium presentation, entitled “Instrumented Correction of Metatarsus Adductus with Hallux Valgus – A Multicenter Radiographic Assessment.” The data from this retrospective clinical study of patients undergoing both the Adductoplasty® and Lapiplasty® procedures included an analysis of 43 patients treated with a mean follow up of 17.7 months, demonstrating positive clinical results and radiographic correction of both the midfoot (metatarsus adductus) and 3D bunion deformities.
All ACFAS presentations, which include additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the studies, will be available on Treace’s website at www.lapiplasty.com/surgeons/journal-publications/ following their presentations at ACFAS. More information on Treace’s products can be found at www.lapiplasty.com.
About the ALIGN3D™ Clinical Study
The ALIGN3D™ clinical study is a prospective, multicenter, post-market study designed to evaluate outcomes of the Lapiplasty® 3D Bunion Correction® procedure 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. 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.
About the Mini3D™ Clinical Study
The Mini3D™ clinical study is a prospective, multicenter, post-market study designed to evaluate the ability of the Lapiplasty® Mini-Incision™ Procedure to consistently and reliably correct all three dimensions of the bunion deformity and maintain the correction following accelerated return to weight-bearing. The study’s primary endpoint is radiographic recurrence of the bunion deformity at 24 months follow up. Secondary endpoints include changes in three-dimensional radiographic alignment; clinical radiographic healing; time to start of weight-bearing in a boot and in shoes; pain; quality of life; range of motion of the big toe joint; scar quality; change in radiographic foot length and width as well as swelling. The study enrolled 105 patients, aged 14 to 58 years, at 9 clinical sites in the United States with 9 participating surgeons.
About the MTA3D™ Clinical Study
The MTA3D™ clinical study is a prospective, multicenter, post-market study designed to evaluate the combined Adductoplasty® and Lapiplasty® Procedures for patients in need of metatarsus adductus and hallux valgus corrective surgery. The study will evaluate for consistent, maintained radiographic correction and patient reported outcome scores following combined Adductoplasty® and Lapiplasty® procedures. The primary effectiveness endpoint is maintenance of radiographic correction of the hallux valgus and metatarsus adductus deformities. Key secondary endpoints include clinical radiographic healing, time to start weight-bearing in boot and shoes, pain, quality of life, and range of motion of the big toe joint. The study will treat up to 80 patients, aged 14 years and up, at up to 13 clinical sites in the United States. Patients will be followed for 5 years following the procedures.
Internet Posting of Information
Treace routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.treace.com. The Company encourages investors and potential investors to consult the Treace website regularly for important information about Treace.
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 bunion surgeons and address the four classes of bunions, Treace introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, the SpeedMTP™ Rapid Compression Implant for addressing bunions through big toe joint fusions, and two systems for minimally invasive osteotomy surgeries: the Nanoplasty™ 3D Minimally Invasive Bunion Correction System and the Percuplasty™ Percutaneous 3D Bunion Correction System. The Company continues to expand its footprint in the foot and ankle market with the introduction of its SpeedPlate™ Rapid Compression Implants, an innovative fixation platform with broad versatility across Lapiplasty®, Adductoplasty® and SpeedMTP™ procedures, as well as other common bone fusion procedures of the foot. For more information, please visit www.treace.com.
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Contacts:
Treace Medical Concepts
Mark L. Hair
Chief Financial Officer
mhair@treace.net
(904) 373-5940
Investors:
Gilmartin Group
Vivian Cervantes
IR@treace.net
FAQ
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