Core Viewpoint - Treace Medical Concepts, Inc. reported preliminary, unaudited revenue results for Q4 and full-year 2025, indicating a mixed performance with a decrease in quarterly revenue but an increase in annual revenue, while emphasizing the company's focus on expanding its market share in bunion procedures and improving profitability [1][9]. Financial Performance - Preliminary revenue for Q4 2025 is estimated to be between $62.1 million and $62.5 million, representing an approximate 9% decrease at the midpoint compared to Q4 2024 [9]. - For the full year 2025, preliminary revenue is projected to be between $212.3 million and $212.7 million, reflecting an approximate 2% increase at the midpoint compared to the previous year, aligning with prior revenue guidance of $211 million to $213 million [9]. Market Position and Strategy - The company experienced mid-single-digit case volume growth in Q4 2025, driven by surgeon adoption of its expanded suite of 3D bunion technologies [3]. - Treace added approximately 202 new active surgeons in 2025, ending the year with around 3,337 active surgeons, marking a 6% increase year-over-year and representing about 33% of the estimated 10,000 U.S. surgeons performing bunion surgery [9]. Future Outlook - While Treace is not providing full-year 2026 guidance at this time, it anticipates continued positive procedure volume growth, despite facing headwinds from broader economic conditions and a shift in product mix [4]. - The company plans to offer financial guidance for 2026 during its Q4 2025 earnings conference call scheduled for February 26, 2026 [5]. Company Overview - Treace Medical Concepts is focused on advancing surgical management standards for bunions and related midfoot deformities, addressing a significant market with approximately 67 million affected Americans, of which 1.1 million are annual surgical candidates [12]. - The company has developed the Lapiplasty3D Bunion Correction System, which aims to correct bunion deformities in all three planes and secure the unstable joint, thereby addressing the root cause of bunions [12].

Core Insights - Treace Medical Concepts, Inc. is showcasing new product innovations and presenting interim data from the ALIGN3D and MTA3D clinical studies at the AOFAS Annual Meeting 2025 [1][2] Product Innovations - The company is highlighting the full commercial release of its expanded bunion portfolio, which includes new technologies such as Nanoplasty, Percuplasty, SpeedMTP, and IntelliGuide PSI, aimed at improving surgical outcomes for bunion patients [2][4] - The Nanoplasty procedure allows for 3D minimally invasive osteotomies through a single 1.5cm incision, while Percuplasty utilizes 0.5cm percutaneous incisions for a more efficient approach [4] - SpeedMTP provides a fusion option for bunion patients with arthritic great toe joints, combining advanced fixation technology for stability [4] - IntelliGuide PSI offers personalized 3D-printed cut guides for enhanced surgical workflow [4] Clinical Study Presentations - The ALIGN3D clinical study presented interim data showing early return to weight bearing in an average of 8.4 days and low radiographic recurrence rates of 7.7% at 48 months and 4.8% at 60 months [5][6] - The MTA3D clinical study is assessing outcomes following combined Adductoplasty and Lapiplasty procedures, with interim data showing significant improvements in pain and patient-reported scores at 12 months [7][12] Company Overview - Treace Medical Concepts aims to advance the standard of care for surgical management of bunions and related midfoot deformities, addressing a market of approximately 65 million Americans, with an estimated 1.1 million surgical candidates annually [11] - The company has developed the Lapiplasty 3D Bunion Correction System, which corrects bunion deformities in all three planes and secures the unstable joint [11][13]

Core Insights - Treace Medical Concepts, Inc. announced positive four-year interim results from its ALIGN3D™ study, demonstrating the effectiveness of the Lapiplasty Procedure for bunion treatment [1][2][3] Company Overview - Treace Medical Concepts is focused on advancing surgical management standards for bunions and related midfoot deformities, with an estimated 1.1 million annual surgical candidates in the U.S. [5][6] - The company has developed the patented Lapiplasty 3D Bunion Correction System, which addresses the root cause of bunions by correcting deformities in three planes [6] Clinical Study Details - The ALIGN3D™ study is a multicenter, prospective clinical study evaluating the Lapiplasty Procedure's outcomes, with 173 patients enrolled across seven clinical sites [3] - Key findings from the study include: - Early return to protected weight-bearing at an average of 7.7 days and return to athletic shoes at 6.5 weeks [5] - Low radiographic recurrence rates of 0.8% for HVA>20° and 8.4% for HVA>15° at 48 months [5] - Significant improvements in pain and patient-reported outcomes, with an 81% improvement in pain and 89% improvement in walking/standing [5] Market Positioning - The publication of the ALIGN3D™ study results is expected to enhance the market differentiation of the Lapiplasty Procedure among surgeons and patients [2] - The company aims to expand its clinical evidence base and continue improving the standard of care for bunion surgery [2]