Treace Medical Concepts (TMCI) FDA Approvals $2.78 0.00 (0.00%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$2.91 +0.13 (+4.68%) As of 05/22/2026 06:29 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Treace Medical Concepts' Drug in the FDA Approval ProcessThis 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. Highlights - September 10,2025Highlights Drug: ALIGN3DAnnounced Date: September 10, 2025Indication: Surgical treatment of Hallux ValgusAnnouncementTreace Medical Concepts, Inc announced it will highlight new product innovations and present new interim data for the ALIGN3D™ and MTA3D™ clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2025 in Savannah, Georgia from September 10-13, 2025.AI SummaryTreace Medical Concepts, Inc. will showcase its latest product innovations and share new interim data from its ALIGN3D™ and MTA3D™ clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting in Savannah, Georgia, on September 10–13, 2025. The company plans to highlight its expanded bunion surgery portfolio and the commercial release of enhanced solutions for surgeons. At its exhibit booth, Treace will introduce several technologies, including Nanoplasty® MIS 3D Bunion Correction, Percuplasty™ Percutaneous 3D Bunion Correction, the SpeedMTP® MTP Fusion System, and IntelliGuide™ patient-specific 3D-printed cut guides. Other featured offerings are the Micro-Lapiplasty® minimally invasive system, the SpeedAkin™ anatomic compression implant, and a range of biologics for foot and ankle fusion procedures. New interim results include ALIGN3D™ data showing an average return to weightbearing in 8.4 days, low radiographic recurrence rates (7.7% at 48 months and 4.8% at 60 months), and sustained pain and function improvements. MTA3D™ 1-year data reveal an 7.9-day return to weightbearing, significant correction of deformities, and notable reductions in pain and patient-reported scores.Read AnnouncementData Presentation - March 28,2025Data Presentation Drug: ALIGN3DAnnounced Date: March 28, 2025Indication: Surgical treatment of Hallux ValgusAnnouncementTreace 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 SummaryTreace 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 AnnouncementInterim Data - September 11,2024Interim Data Drug: ALIGN3DAnnounced Date: September 11, 2024Indication: Surgical treatment of Hallux ValgusAnnouncementTreace 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 SummaryTreace 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 Has Treace Medical Concepts received FDA approval? As of now, Treace Medical Concepts (TMCI) has not received any FDA approvals for its therapy in the last two years. What drugs has Treace Medical Concepts submitted to the FDA? In the past two years, Treace Medical Concepts (TMCI) has reported FDA regulatory activity for ALIGN3D. What is the most recent FDA event for Treace Medical Concepts? The most recent FDA-related event for Treace Medical Concepts occurred on September 10, 2025, involving ALIGN3D. The update was categorized as "Highlights," with the company reporting: "Treace Medical Concepts, Inc announced it will highlight new product innovations and present new interim data for the ALIGN3D™ and MTA3D™ clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2025 in Savannah, Georgia from September 10-13, 2025." What conditions do Treace Medical Concepts' current drugs treat? Currently, Treace Medical Concepts has one therapy (ALIGN3D) targeting the following condition: Surgical treatment of Hallux Valgus. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AC Immune FDA EventsAgios Pharmaceuticals FDA EventsAssembly Biosciences FDA EventsBriacell Therap FDA EventsBioLineRx FDA EventsFibroBiologics FDA EventsGilead Sciences FDA EventsOncolytics Biotech FDA EventsRegeneron Pharmaceuticals FDA EventsAbbVie FDA EventsMerck & Co., Inc. FDA EventsAgenus FDA EventsAdagio Medical FDA EventsAktis Oncology FDA EventsAkari Therapeutics FDA Events 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 Related Companies Spyglass Pharma FDA Events Brainsway FDA Events NeuroPace FDA Events Tactile Systems Technology FDA Events Delcath Systems FDA Events ClearPoint Neuro FDA Events Sight Sciences FDA Events Profound Medical FDA Events Orchestra BioMed FDA Events Sanara MedTech FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:TMCI last updated on 9/10/2025 by MarketBeat.com Staff. 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Highlights - September 10,2025Highlights Drug: ALIGN3DAnnounced Date: September 10, 2025Indication: Surgical treatment of Hallux ValgusAnnouncementTreace Medical Concepts, Inc announced it will highlight new product innovations and present new interim data for the ALIGN3D™ and MTA3D™ clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2025 in Savannah, Georgia from September 10-13, 2025.AI SummaryTreace Medical Concepts, Inc. will showcase its latest product innovations and share new interim data from its ALIGN3D™ and MTA3D™ clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting in Savannah, Georgia, on September 10–13, 2025. The company plans to highlight its expanded bunion surgery portfolio and the commercial release of enhanced solutions for surgeons. At its exhibit booth, Treace will introduce several technologies, including Nanoplasty® MIS 3D Bunion Correction, Percuplasty™ Percutaneous 3D Bunion Correction, the SpeedMTP® MTP Fusion System, and IntelliGuide™ patient-specific 3D-printed cut guides. Other featured offerings are the Micro-Lapiplasty® minimally invasive system, the SpeedAkin™ anatomic compression implant, and a range of biologics for foot and ankle fusion procedures. New interim results include ALIGN3D™ data showing an average return to weightbearing in 8.4 days, low radiographic recurrence rates (7.7% at 48 months and 4.8% at 60 months), and sustained pain and function improvements. MTA3D™ 1-year data reveal an 7.9-day return to weightbearing, significant correction of deformities, and notable reductions in pain and patient-reported scores.Read Announcement
Data Presentation - March 28,2025Data Presentation Drug: ALIGN3DAnnounced Date: March 28, 2025Indication: Surgical treatment of Hallux ValgusAnnouncementTreace 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 SummaryTreace 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
Interim Data - September 11,2024Interim Data Drug: ALIGN3DAnnounced Date: September 11, 2024Indication: Surgical treatment of Hallux ValgusAnnouncementTreace 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 SummaryTreace 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
