Treace Enters High Volume Osteotomy Market with Nanoplasty™ 3D Minimally Invasive Bunion Correction™ Procedure

Rhea-AI Summary

Treace Medical Concepts (TMCI) has announced the market release of the Nanoplasty™ 3D Minimally Invasive Bunion Correction™ System, marking its entry into the metatarsal osteotomy segment. This segment represents approximately 70% of the 450,000 annual bunion surgeries in the U.S. The new system performs bunion correction through a 1.5-centimeter hidden incision on the foot's side. Full commercialization is expected in the first half of 2025. This launch expands Treace's presence in the $5B+ US bunion market, complementing their existing Lapiplasty® and Adductoplasty® procedures.

Positive

• Entry into metatarsal osteotomy segment, representing 70% of 450,000 annual U.S. bunion surgeries
• Expansion into $5B+ US bunion market opportunity
• Product portfolio diversification with addition of minimally invasive solution

Negative

• market release phase indicates delayed full revenue potential until H1 2025

Insights

Medical Device Market Analyst

The launch of Nanoplasty™ represents a significant strategic expansion for Treace into the metatarsal osteotomy segment, which accounts for 70% of U.S. bunion surgeries. This positions the company to tap into an estimated $5B+ market opportunity. The technology's minimally invasive approach through a 1.5cm hidden incision addresses growing patient demand for less invasive procedures while maintaining 3D correction capabilities.

The system's design focus on reproducibility and reduced learning curve could accelerate surgeon adoption compared to existing MIS systems. With full commercialization planned for H1 2025, this product launch could significantly expand Treace's addressable market and surgeon customer base beyond their current Lapiplasty® users. The involvement of prominent surgeons from institutions like Duke University in the design process adds credibility and potential for faster market acceptance.

Positions Treace to Significantly Increase Penetration into Overall Bunion Market and Expand Surgeon Customer Base

PONTE VEDRA, Fla., Nov. 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 limited market release of the Nanoplasty™ 3D Minimally Invasive Bunion Correction^™ System and Procedure, a revolutionary approach to minimally invasive (MIS) bunion surgery.

The Nanoplasty™ MIS System is designed to deliver a reproducible 3D correction of the bunion deformity through a cosmetically appealing, hidden incision on the side of the foot and help patients get back to their active lifestyles. This system represents the Company’s first entry point 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 with the patented Lapiplasty^® Procedure, we are excited to announce the limited market release of the first in our lineup of minimally invasive osteotomy solutions,” stated John T. Treace, CEO and Founder of Treace. “The Nanoplasty™ Procedure allows us, for the first time, to address the large metatarsal osteotomy segment of our $5B+ US bunion market opportunity. The Nanoplasty™ Procedure, combined with our market-leading Lapiplasty® and Adductoplasty® Procedures, represents a significant milestone in our strategy to provide a comprehensive portfolio of elegantly instrumented 3D bunion solutions to address the evolving needs of surgeons and patients alike.”

Surgeon design team member for the Nanoplasty™ System, Jonathan Kaplan, MD (Associate Chief of the Foot and Ankle Division at Duke University) commented, “The Nanoplasty™ System is a game changer for surgeons seeking to engage the growing patient demand for MIS osteotomy bunion surgery without the complexity and steep learning curves of current MIS osteotomy systems on the market. The Nanoplasty™ System offers surgeons an advanced, instrumented solution allowing them to reproducibly correct all three planes of the patient’s bunion deformity through a discreet 1.5 centimeter incision hidden on the side of the foot.”

“As MIS surgeons, it’s our goal to alleviate patients’ bunion pain, allow them a quick return to their active lives, while minimizing incision size and visual scars. I am excited to partner with Treace and fellow MIS design team members, Tyler Gonzalez, MD, Holly Johnson, MD, Brian Loder, DPM, Oliver Schipper, MD, and Ettore Vulcano, MD, to bring leading-edge MIS technologies like Nanoplasty™ to patients,” Dr. Kaplan concluded.

Full commercialization of the Nanoplasty™ 3D MIS Bunion Correction^™ System is anticipated to occur within the first half of 2025.

More information on Treace’s products can be found at www.lapiplasty.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 Nanoplasty™ System in the first half of 2025 and the Company’s expectation that the combination of Lapiplasty® and Nanoplasty™ Procedures positions it well to continue to execute its strategy of becoming a comprehensive bunion solutions company and drive further penetration into the $5B+ US bunion market opportunity. 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.
2. Okuda R, et al. JBJS 2009; Okuda R, et al. JBJS 2007.

Dr. Kaplan 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 Treace Medical (TMCI) fully commercialize the Nanoplasty™ System?

Treace Medical plans to fully commercialize the Nanoplasty™ 3D MIS Bunion Correction™ System within the first half of 2025.

What market segment does the new Nanoplasty™ System target for TMCI?

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

What is the size of the incision required for TMCI's Nanoplasty™ procedure?

The Nanoplasty™ procedure requires a discreet 1.5-centimeter incision hidden on the side of the foot.