Treace Highlights New Product Innovations and Updated Positive Clinical Study Data at the 2026 ACFAS Annual Scientific Conference
PONTE VEDRA, Fla., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. ("Treace" or the "Company") (NASDAQ:TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities, today announced it will highlight new product innovations and present new interim data for the ALIGN3D™, MTA3D™, and SpeedMTP® clinical studies at the American College of Foot and Ankle Surgeons ("ACFAS") Annual Scientific Conference in Las Vegas, Nevada from February 24-26, 2026.
"We are proud to showcase our latest clinical data and innovations at ACFAS, including our next-generation Lapiplasty® instrumentation and fixation technology platforms," said John T. Treace, CEO, Founder and Chairman of Treace. "These new Lapiplasty® technologies further advance our comprehensive 3D bunion solution portfolio, also featuring Nanoplasty®, Percuplasty™, SpeedMTP®, and IntelliGuide® PSI, to accelerate our penetration into the bunion market and advance our leadership position. We also look forward to sharing compelling clinical evidence from prospective, multicenter studies that continues to differentiate our flagship Lapiplasty® and Adductoplasty® procedures, as well as new retrospective clinical data on our SpeedMTP® procedure."
Treace will feature clinical data and several new technologies at our ACFAS exhibit booth and host surgeon training events on these innovations, including:
- SpeedTMT™ Rapid Compression Implant: New at ACFAS 2026, SpeedTMT™ is our latest advancement in Lapiplasty® SpeedPlate® fixation. SpeedTMT™ utilizes our novel hybrid fixation technology, combining SpeedPlate® dynamic fixation with our FastPitch® locking screws for our most robust Lapiplasty® fixation option, while still maintaining an ultra-low profile. Full commercialization of SpeedTMT™ is expected in the second half of 2026.
- Lapiplasty® Lightning™ System: New at ACFAS 2026, the Lightning system is our next-generation Lapiplasty® instrumentation platform. Lightning is designed to provide surgeons with greater accuracy and control of the 3D correction while also reducing surgical steps for a faster procedure. Full commercialization of the Lightning system is expected in late 2026.
- Nanoplasty® MIS 3D Bunion Correction: The Nanoplasty® procedure is designed to accelerate surgeon access to 3D MIS osteotomies and is performed through a single 1.5cm hidden incision on the side of the foot. Nanoplasty® is a disruptive system for rapid adoption of MIS through a guided saw cut (no burr learning curve is required), instrumentation to dial-in the 3D correction, and the predictable strength of locking fixation designed for early weightbearing.
- Percuplasty™ Percutaneous 3D Bunion Correction: The Percuplasty™ procedure is our second system designed to accelerate surgeon access to MIS osteotomies. Performed through 0.5cm percutaneous incisions, Percuplasty™ is designed to bring a more efficient and predictable approach to MIS surgeons through self-drilling screw implants and elegant instrumentation that dials in the 3D correction and accurately targets implant placement.
- SpeedMTP® MTP Fusion System: SpeedMTP® extends the benefits of SpeedPlate® technology to provide surgeons with a fusion option to address bunion patients with arthritic great toe (MTP) joints. SpeedMTP® combines our market-leading SpeedPlate® dynamic compression fixation technology with our Fastpitch® locking screws to rapidly deliver an ultra-low profile implant with high-strength and stability.
- IntelliGuide® PSI: IntelliGuide® PSI is a platform technology delivering personalized 3D-printed cut guides for Lapiplasty® and Adductoplasty® procedures. IntelliGuide® delivers intelligent pre-op 3D planning and titanium 3D-printed guides with integrated 3D correction for a streamlined surgical workflow.
ALIGN3D™ Lapiplasty® Clinical Study Presentation
The ALIGN3D™ Lapiplasty® clinical study podium presentation, "Association Between Sesamoid Position and Long Term Outcomes Following Triplanar Tarsometatarsal Arthrodesis at 4-Year Follow-Up", will be presented by Daniel Hatch, DPM, Foot & Ankle Center of the Rockies (Greeley, CO) on Tuesday, February 24 in the 10:15am PST session.
The featured interim data from the prospective, five-year, multicenter ALIGN3D™ clinical study included interim analysis of 146 of 173 total patients treated with at least four years of follow-up following the Lapiplasty® Procedure. The data showed:
- Early return to weight bearing in a walking boot at an average 8.4 days;
- Low radiographic recurrence rates using HVA>15° of 8.4% (12 of 143 patients) at 48 months; and
- Risk of recurrence at 48 months was 95% lower in patients with corrected tibial sesamoid position of 3 or less (an indicator of 3-plane correction) at 6 weeks post-op.
MTA3D™ Adductoplasty® Clinical Study Presentation
The MTA3D™ Adductoplasty® clinical study podium presentation, "Interim 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", will be presented by Paul Dayton, DPM, Foot & Ankle Center of Iowa (Ankeny, IA) on Tuesday, February 24 in the 10:15am PST session.
The featured interim data from the prospective, two-year, multicenter MTA3D™ clinical study of the patients undergoing both the Adductoplasty® and Lapiplasty® procedures included interim analysis of 33 of 60 and 14 of 60 patients treated with at least one and two year follow-up, respectively. The data showed:
- Early return to weight bearing in a walking boot at an average 7.9 days;
- Clinically significant improvement and maintenance of radiographic measures of both midfoot (metatarsus adductus) and 3D bunion deformity correction through 24 months; and
- Clinically significant reduction in pain and patient-reported scores (VAS, MOxFQ, and PROMIS) through 24 months.
SpeedMTP® Retrospective Clinical Study Scientific Poster (SCI765)
Results from a retrospective study on the SpeedMTP® system will be presented by Jody McAleer, DPM, Jefferson City Medical Group (Jefferson City, MO) as a poster presentation, entitled "Interim 6-Month Analysis of a Retrospective Review of First MTP Healing and Return to Weight-Bearing Following Arthrodesis Using a Dynamic Compression Implant System." The data from this retrospective clinical study of patients undergoing great toe joint (1st MTP) fusion with the SpeedMTP® system included an analysis of 43 patients treated with a mean follow up of 6.4 months, demonstrating early return to weight bearing in a walking boot at an average of 3.7 days with full radiographic union achieved in all patients at 6 months follow-up.
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 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.
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 a 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 2 years following the procedures.
Forward-Looking Statements
This press contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements, including, but not limited to, the Company's: anticipated future product launches and the timing of such product launches; and acceleration of its penetration into the bunion market and advancement of its leadership position. Forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company's business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of Treace's public filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 27, 2025, and Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of their date, and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
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 67 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, and the SpeedMTP® 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.
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Contacts:
Treace Medical Concepts
Mark L. Hair
Chief Financial Officer
[email protected]
(904) 373-5940
Investors:
Gilmartin Group
Philip Trip Taylor
[email protected]
