FDA Events for Treace Medical Concepts (TMCI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Treace Medical Concepts (TMCI).
Over the past two years, Treace Medical Concepts has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALIGN3D. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ALIGN3D - FDA Regulatory Timeline and Events
ALIGN3D is a drug developed by Treace Medical Concepts for the following indication: Surgical treatment of Hallux Valgus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALIGN3D
- Announced Date:
- March 28, 2025
- Indication:
- Surgical treatment of Hallux Valgus
Announcement
Treace Medical Concepts, Inc 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.
AI Summary
Treace Medical Concepts, Inc. announced that at the 2025 American College of Foot and Ankle Surgeons Annual Meeting in Phoenix, Arizona, they presented updated interim data from their ALIGN3D™ and Mini3D™ Lapiplasty® clinical studies. In addition, the company shared the first results from the MTA3D™ Adductoplasty® clinical study. These presentations highlight positive clinical outcomes, including early return to weightbearing and significant improvements in pain and radiographic measures, which support the reliability of their new surgical procedures for bunion and midfoot deformity corrections.
CEO John T. Treace emphasized the company’s commitment to backing its surgical technologies with robust clinical data. The new information demonstrates how the ALIGN3D™, Mini3D™, and MTA3D™ studies reinforce the effectiveness of Lapiplasty® and Adductoplasty® procedures, aiming to improve surgical treatment options for patients with bunions and related foot deformities.
Read Announcement- Drug:
- ALIGN3D
- Announced Date:
- September 11, 2024
- Indication:
- Surgical treatment of Hallux Valgus
Announcement
Treace Medical Concepts, Inc announced it will highlight new product innovations and present new interim data for the ALIGN3D™ and Mini3D™ Lapiplasty® clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2024 in Vancouver, British Columbia, Canada from September 11-14, 2024.
AI Summary
Treace Medical Concepts, Inc. announced it will showcase its latest product innovations and share promising interim data for its ALIGN3D™ and Mini3D™ Lapiplasty® clinical studies at the upcoming American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2024. The conference will take place in Vancouver, British Columbia, Canada from September 11-14, 2024.
At the event, Treace will present new findings that demonstrate continued success in patient outcomes and surgical procedures. The ALIGN3D™ study data highlights sustained benefits at three and four years post-procedure, while the Mini3D™ study shows positive results at one and two years. CEO John T. Treace emphasized the company’s commitment to advancing the standard of care for bunion and midfoot deformities. Attendees will also witness the company’s dedication to innovative instrumented solutions designed to meet evolving surgical needs.
Read Announcement
Treace Medical Concepts FDA Events - Frequently Asked Questions
As of now, Treace Medical Concepts (TMCI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Treace Medical Concepts (TMCI) has reported FDA regulatory activity for ALIGN3D.
The most recent FDA-related event for Treace Medical Concepts occurred on March 28, 2025, involving ALIGN3D. The update was categorized as "Data Presentation," with the company reporting: "Treace Medical Concepts, Inc 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."
Currently, Treace Medical Concepts has one therapy (ALIGN3D) targeting the following condition: Surgical treatment of Hallux Valgus.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TMCI) was last updated on 7/10/2025 by MarketBeat.com Staff
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