Treace Expands Reach into High-Volume Osteotomy Market with Second MIS Osteotomy Platform, Percuplasty™ Percutaneous 3D Bunion Correction® Procedure

Rhea-AI Summary

Treace Medical Concepts (TMCI) announced the market release of its Percuplasty™ Percutaneous 3D Bunion Correction® System, marking the company's second entry into the metatarsal osteotomy segment. This segment represents approximately 70% of the 450,000 annual bunion surgeries in the U.S.

The Percuplasty™ System offers a minimally invasive approach through percutaneous incisions, designed to minimize post-operative pain and accelerate recovery. This launch follows the Nanoplasty™ System release, expanding Treace's portfolio in the $5B+ US bunion market. Full commercialization is expected in the second half of 2025.

Positive

• Expansion into largest bunion surgery segment (70% of 450,000 annual US procedures)
• Entry into $5B+ market opportunity
• Product portfolio diversification with second minimally invasive system

Negative

• Full commercialization delayed until H2 2025
• Currently market release only

Insights

Medical Device Analyst

The launch of Percuplasty™ represents a strategic expansion into the metatarsal osteotomy segment, which accounts for roughly 70% of the 450,000 annual U.S. bunion surgeries. This move could significantly increase Treace's total addressable market within the $5B+ US bunion market. The system's minimally invasive approach addresses growing patient demand for less invasive procedures with faster recovery times.

The technology's key differentiator lies in its instrumented, reproducible approach to 3D correction through percutaneous incisions. This addresses two critical market needs: surgeon adoption ease and patient recovery optimization. The planned full commercialization in H2 2025 allows time for clinical validation and surgeon training programs, important for successful market penetration in the medical device sector.

Simple explanation: Think of this like introducing a new, more precise GPS system for surgeons - it makes a complex operation simpler and more accurate, while being less invasive for patients, similar to keyhole surgery versus traditional open surgery.

Market Research Analyst

This product launch strategically positions Treace to capture a larger share of the high-volume osteotomy market. With their second platform targeting the dominant 70% segment of bunion surgeries, the company is executing a clear market penetration strategy. The technology's focus on reproducibility and ease of use directly addresses the primary adoption barriers in minimally invasive surgery (MIS).

The staged commercialization approach, starting with a market release, is a prudent strategy that allows for controlled market feedback and potential refinements before full launch. This could help maintain premium pricing and optimize market acceptance. For investors, this represents a significant growth catalyst, expanding both the addressable market and potential surgeon customer base.

Simple explanation: Imagine a company that previously sold only premium cars now introducing a mid-range model - they're expanding their market reach while maintaining their reputation for quality, potentially reaching many more customers.

Positions Treace to Significantly Increase Share of Overall Bunion Market and Expand Surgeon Customer Base

PONTE VEDRA, Fla., Dec. 30, 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 limited market release and first surgical cases utilizing the Percuplasty™ Percutaneous 3D Bunion Correction^® System and Procedure.

The Percuplasty™ System provides an instrumented, reproducible approach to 3D correction of the bunion deformity through cosmetically appealing, percutaneous incisions designed to minimize post-op pain and swelling, and help patients get back to their active lifestyles quickly. This system represents the Company’s second entry into the metatarsal osteotomy segment--the largest segment of the bunion market--currently estimated to represent approximately 70% of the 450,000 bunion surgeries performed annually in the U.S.¹

“As the pioneers and leaders in 3D Bunion Correction^®, we are excited to announce the limited market release of Percuplasty™ Percutaneous 3D Bunion Correction System, the second offering in our lineup of instrumented systems designed to democratize 3D minimally invasive osteotomy surgery,” stated John T. Treace, CEO and Founder of Treace. “The Percuplasty™ System follows the limited release of the Nanoplasty™ System, providing an additional, highly differentiated solution in the large metatarsal osteotomy segment of our $5B+ US bunion market opportunity. This represents another significant milestone in our strategy to provide a comprehensive portfolio of instrumented 3D bunion systems to meet the evolving needs of surgeons and patients.”

Oliver N. Schipper MD, of Anderson Orthopaedic Clinic and a member of Treace’s Surgeon Design Team, who performed initial cases with the Percuplasty™ System, commented, “I expect Percuplasty™ will expand surgeon and patient access to the improved recovery and cosmetic benefits of percutaneous bunion surgery through its elegant instrumentation designed to precisely dial in the correction in all three planes and guide the application of fast, low-profile fixation through truly “poke hole” incisions.” Dr. Schipper continued, “For surgeons who are seeking to meet the growing patient demand for MIS bunion surgery without the complexity and steep learning curve traditionally associated with these challenging surgical approaches, the Percuplasty™ System is the new benchmark designed to deliver the user-friendly, reproducible results surgeons have come to expect from Treace.”

Full commercialization of the Percuplasty™ Percutaneous 3D Bunion Correction^® System is anticipated to occur in the second half of 2025.

More information on Treace’s products can be found at www.treace.com

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 planned full commercialization of the Company’s Percuplasty™ System in the second half of 2025, and the Company’s expectations regarding expanded surgeon and patient access, growing patient demand for MIS bunion surgery, and that the Company is positioned to significantly increase its share of the overall bunion market and expand its surgeon customer base. 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, 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 LinkedIn, X, Facebook and Instagram.

1. iData Research, Inc., 2022.
   

Dr. Schipper is a paid consultant for the Company.

Contacts:

Treace Medical Concepts, Inc.

Mark L. Hair
Chief Financial Officer
mhair@treace.net
(904) 373-5940

Investors:
Gilmartin Group
Vivian Cervantes
IR@treace.net

FAQ

When will TMCI's Percuplasty™ System be fully commercialized?

Full commercialization of the Percuplasty™ System is expected in the second half of 2025.

What market share does the metatarsal osteotomy segment represent for TMCI?

The metatarsal osteotomy segment represents approximately 70% of the 450,000 bunion surgeries performed annually in the U.S.

What is the total market opportunity for TMCI's bunion correction systems?

The US bunion market opportunity is estimated to be over $5 billion.

How many minimally invasive bunion correction systems does TMCI now offer?

TMCI now offers two minimally invasive systems: the Percuplasty™ System and the Nanoplasty™ System.

What are the key benefits of TMCI's new Percuplasty™ System?

The system offers minimally invasive surgery through percutaneous incisions, designed to minimize post-op pain and swelling, and enable faster patient recovery.