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Treace Announces First Cases Utilizing RedPoint™ Intelliguide™ Patient Specific Instrumentation with the Adductoplasty® System for Correction of Midfoot Deformities

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Treace Medical Concepts (NASDAQ: TMCI) announced the successful implementation of IntelliGuide™ PSI technology with the Adductoplasty® System, marking a significant advancement in midfoot deformity correction. This system is the first patient-specific cut guide system available in the U.S. for bunion and midfoot deformity correction.

The technology uses AI-enabled software to convert patient CT-scans into pre-operative surgical plans and creates 3D-printed cut guides customized to each patient's deformity. The company has initiated a market release of IntelliGuide™ PSI for the Adductoplasty® Procedure, with full market release expected in the first half of 2025. Notably, midfoot deformities may affect up to 30% of bunion patients.

Treace Medical Concepts (NASDAQ: TMCI) ha annunciato l'implementazione con successo della tecnologia IntelliGuide™ PSI con il sistema Adductoplasty®, segnando un importante passo avanti nella correzione delle deformità del mesopiede. Questo sistema è il primo sistema di guida per tagli specifico per il paziente disponibile negli Stati Uniti per la correzione di alluci valghi e deformità del mesopiede.

La tecnologia impiega software abilitato all'IA per trasformare le TC dei pazienti in piani chirurgici pre-operatori e crea guide per il taglio stampate in 3D personalizzate per ogni deformità del paziente. L'azienda ha avviato il rilascio sul mercato dell'IntelliGuide™ PSI per la procedura Adductoplasty®, con un rilascio completo previsto nella prima metà del 2025. È importante notare che le deformità del mesopiede possono colpire fino al 30% dei pazienti con alluci valghi.

Treace Medical Concepts (NASDAQ: TMCI) anunció la implementación exitosa de la tecnología IntelliGuide™ PSI con el sistema Adductoplasty®, marcando un avance significativo en la corrección de las deformidades del mediopié. Este sistema es la primera guía de corte específica para el paciente disponible en los EE. UU. para la corrección de juanetes y deformidades del mediopié.

La tecnología utiliza software habilitado por IA para convertir las tomografías computarizadas de los pacientes en planes quirúrgicos preoperatorios y crea guías de corte impresas en 3D personalizadas para cada deformidad del paciente. La empresa ha iniciado un lanzamiento en el mercado de IntelliGuide™ PSI para el procedimiento Adductoplasty®, con un lanzamiento completo previsto para la primera mitad de 2025. Es importante señalar que las deformidades del mediopié pueden afectar hasta el 30% de los pacientes con juanetes.

Treace Medical Concepts (NASDAQ: TMCI)는 IntelliGuide™ PSI 기술의 성공적인 구현을 Adductoplasty® 시스템과 함께 발표했습니다. 이는 중족부 기형 교정의 중요한 발전을 의미합니다. 이 시스템은 미국에서 사용할 수 있는 최초의 환자 맞춤형 절단 가이드 시스템으로, 무지외반증과 중족부 기형 교정을 위해 개발되었습니다.

이 기술은 AI 기반 소프트웨어를 사용하여 환자의 CT 스캔을 수술 전 계획으로 변환하고 각 환자의 기형에 맞춤화된 3D 프린팅 절단 가이드를 생성합니다. 이 회사는 Adductoplasty® 절차를 위해 IntelliGuide™ PSI의 시장 출시를 시작했으며, 2025년 상반기에 전체 시장 출시가 예정되어 있습니다. 주목할 만한 점은, 중족부 기형이 무지외반증 환자의 최대 30%에 영향을 미칠 수 있다는 것입니다.

Treace Medical Concepts (NASDAQ: TMCI) a annoncé la mise en œuvre réussie de la technologie IntelliGuide™ PSI avec le système Adductoplasty®, marquant une avancée significative dans la correction des déformations du médio-pied. Ce système est le premier guide de découpe spécifique au patient disponible aux États-Unis pour la correction des oignons et des déformations du médio-pied.

La technologie utilise un logiciel alimenté par l'IA pour convertir les scanners CT des patients en plans chirurgicaux préopératoires et crée des guides de découpe imprimés en 3D personnalisés pour chaque déformation du patient. L'entreprise a lancé la mise sur le marché de l'IntelliGuide™ PSI pour la procédure Adductoplasty®, avec un lancement complet prévu pour la première moitié de 2025. Il est à noter que les déformations du médio-pied peuvent affecter jusqu'à 30 % des patients souffrant d'oignons.

Treace Medical Concepts (NASDAQ: TMCI) kündigte die erfolgreiche Implementierung der IntelliGuide™ PSI-Technologie mit dem Adductoplasty®-System an, was einen bedeutenden Fortschritt bei der Korrektur von Deformitäten im Mittelfuß darstellt. Dieses System ist das erste patientenspezifische Schnittführungs-System, das in den USA zur Korrektur von Hallux valgus und Mittelfußdeformitäten verfügbar ist.

Die Technologie nutzt KI-gestützte Software, um CT-Scans von Patienten in präoperative chirurgische Pläne umzuwandeln und erstellt 3D-gedruckte Schnittführungen, die auf die Deformität jedes Patienten zugeschnitten sind. Das Unternehmen hat mit der Markteinführung von IntelliGuide™ PSI für das Adductoplasty®-Verfahren begonnen, wobei eine vollständige Markteinführung in der ersten Hälfte von 2025 erwartet wird. Bemerkenswert ist, dass Mittelfußdeformitäten bis zu 30 % der Patienten mit Hallux valgus betreffen können.

Positive
  • First-to-market with patient-specific cut guide system for bunion/midfoot deformities in the U.S.
  • Technology addresses a significant market with up to 30% of bunion patients affected by midfoot deformities
  • Planned full market release in first half of 2025 indicates clear commercialization timeline
Negative
  • market release phase could restrict immediate revenue potential
  • Full market release not expected until first half of 2025

Insights

The launch of IntelliGuide™ PSI for Adductoplasty® represents a significant technological advancement in bunion and midfoot deformity correction. This first-to-market patient-specific instrumentation system combines AI-enabled software with CT imaging to create personalized surgical guides, potentially improving precision and outcomes.

The addressable market is substantial, with up to 30% of bunion patients potentially having associated midfoot deformities. The technology's integration into both Lapiplasty® and Adductoplasty® procedures could strengthen Treace's competitive position and drive adoption. The planned progressive rollout with full market release by H1 2025 suggests a measured approach to ensure successful implementation and training.

The system's AI capabilities and personalization features align with broader healthcare trends toward precision medicine, while the 3D-printed guides may help reduce procedure time and improve surgical accuracy. Initial surgeon feedback indicates strong clinical benefits, which could accelerate market penetration and potentially improve reimbursement prospects.

This product launch strengthens Treace's market positioning in the foot surgery space. The company's strategy to build a comprehensive digital technology ecosystem demonstrates forward-thinking market development. The release approach allows for controlled market penetration while gathering real-world evidence and refining implementation protocols.

The technology addresses a significant market need, targeting the estimated 30% of bunion patients with midfoot deformities. This represents a substantial expansion opportunity within their existing customer base. The positive initial surgeon feedback suggests potential for strong adoption rates, particularly given the technology's ability to enhance surgical planning and execution.

The timing of full market release in H1 2025 provides a clear catalyst for future growth. This launch could help Treace maintain its leadership position and potentially expand market share in the competitive orthopedic space.

PONTE VEDRA, Fla., Dec. 04, 2024 (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 successful completion of the first cases combining IntelliGuide™ PSI technology with the Adductoplasty® System for a CT-based, patient specific correction personalized to the patient’s unique midfoot deformity.

IntelliGuide™ PSI, incorporating RedPoint™ technology, is the first and only patient-specific cut guide system available for correction of bunion and/or midfoot deformities in the U.S. IntelliGuide™ PSI provides an AI-enabled software approach to convert a patient’s CT-scan to a pre-operative surgical plan and produce a 3D-printed cut guide specific to the patient’s deformity for efficient and personalized intra-operative guidance. It is estimated that midfoot deformities, such as metatarsus adductus, may occur in up to 30% of bunion patients.1,2

Treace has now initiated a limited market release of IntelliGuide™ PSI for the Adductoplasty® Procedure and plans to expand surgeon access of IntelliGuide™ for both the Lapiplasty® and Adductoplasty® procedures progressively over the coming months with full market release expected within the first half of 2025.

“IntelliGuide™ PSI further advances our market leadership position in the surgical management of bunion and midfoot deformities, extending the established benefits of PSI personalized approaches to our Lapiplasty® and Adductoplasty® Procedures,” said John T. Treace, CEO, Founder and Board Member of Treace. “We look forward to further building out our ecosystem of enabling digital technologies as part of our strategy to provide a comprehensive portfolio of bunion and related midfoot solutions to address the evolving needs of our surgeon customers and patients.”

Eric Kuhlman, DPM of Center for Spine & Orthopedics in Denver, who performed an initial IntelliGuide™ Adductoplasty® case commented, “This technology is going to revolutionize the way that I approach treating patients with bunion and related midfoot deformities. The virtual planning process helped me fully visualize the complex three-dimensional metatarsus adductus midfoot correction before stepping foot in the OR and the 3D-printed cut guides added a new level of intra-operative precision, efficiency, and confidence to the procedure. Just as PSI has advanced other areas of orthopedics, I expect IntelliGuide™ PSI to rapidly expand our understanding and treatment of these common, yet challenging foot deformities.”

Forward-Looking Statements
This press release 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 expectations of innovation, product commercialization, market performance, and growth. 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, 2023, which was filed with the SEC on February 27, 2024, and its subsequent SEC filings. 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.

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 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 bunion patients, Treace has introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities. 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® and Adductoplasty® procedures, as well as other common bone fusion procedures of the foot. For more information, please visit www.treace.com.

To learn more about Treace, connect with us on LinkedInXFacebook and Instagram.

1. Aiyer AA, et al. Foot Ankle Int. 2014; 35:1292-1297.
2. Gribbin CK, et al. Foot Ankle Int. 2017; 38:14-19.

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

What is the new technology announced by Treace Medical Concepts (TMCI)?

Treace announced IntelliGuide™ PSI technology with the Adductoplasty® System, the first patient-specific cut guide system for bunion and midfoot deformity correction in the U.S., using AI-enabled software and 3D-printed cut guides.

When will Treace (TMCI) fully release IntelliGuide™ PSI to the market?

Treace plans to fully release IntelliGuide™ PSI for both Lapiplasty® and Adductoplasty® procedures within the first half of 2025.

What percentage of bunion patients may have midfoot deformities according to Treace (TMCI)?

According to the announcement, midfoot deformities may occur in up to 30% of bunion patients.

Treace Medical Concepts, Inc.

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