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

PONTE VEDRA, Fla., Dec. 04, 2024 (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 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.

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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.

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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

[email protected]

(904) 373-5940

Investors:

Gilmartin Group

Vivian Cervantes

[email protected]