Celebrating 30 Years of Clinical Use, More Than 100,000 Patients Worldwide Have Benefited From TrueLok Circular Fixation Products

Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the launch of the TrueLok^™ Phantom and Tornado Hinges, the latest addition to the Orthopedics TrueLok circular frame portfolio. Both hinges are designed for use with TrueLok circular frame offerings, including the TrueLok EVO Ring Fixation System introduced globally last year. The TrueLok EVO System is the only circular ring construct on the market that consists of both radiolucent rings and struts for clearer visualization of the bone under X-ray while also providing a lightweight frame for patient comfort.

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TrueLok™ Phantom and Tornado Hinges are the latest addition to the TrueLok circular frame portfolio that has been used to treat more than 100,000 patients worldwide over the last 30 years. (Photo: Business Wire)

“The TrueLok circular frame is the gold standard for external fixation for complex limb reconstruction and deformity correction procedures,” said Dr. David Frumberg, an orthopedic surgeon who directs the Limb Restoration and Lengthening Program in New Haven, Connecticut. “The introduction of the new Phantom and Tornado Hinges for the TrueLok system are important advancements that have changed how I apply circular frames by giving me the confidence that the patient will regain a more natural joint motion. The TrueLok EVO System with the Phantom Hinges has become my go-to construct for equinus deformity corrections amongst other applications.”

The TrueLok Phantom Hinge allows surgeons to achieve precise alignment when performing joint distraction or contracture correction procedures by maintaining the axis of rotation and joint mobility. The hinge is radiolucent, which makes it ideal for use with the TrueLok EVO System. The TrueLok Tornado Hinge features a flexible spring-like design that enables the natural joint motion to be restored following a joint distraction procedure. The Phantom Hinges and the Tornado Hinges are both for use in ankle and knee applications and sterile packaged for quick and easy use.

“As we celebrate the 30-year legacy of the TrueLok Ring Fixation System this year, we are proud to continue to innovate and build on this foundational technology that has to date been used by surgeons to treat more than 100,000 patients worldwide,” said Kimberley Elting, President of Global Orthopedics. “With the launch of these two new additions, Orthofix now has the most comprehensive hinge portfolio, demonstrating a continued commitment to invest in our industry-leading circular frame portfolio.”

Orthofix is the only orthopedic company that offers a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction and deformity correction. For those attending the 2023 Limb Lengthening and Reconstruction Society annual meeting in Lake Tahoe, CA, please visit the Orthofix booth to learn more about the TrueLok Circular Ring Fixation System.

The TrueLok family of products addresses the approximately $125 million circular external fixation market in the U.S. and the $278 million total global market¹. TrueLok Phantom and Tornado Hinges are now available in the U.S. and international markets and are designed for use with the TrueLok circular frame portfolio. Learn more about the full portfolio of Orthofix Orthopedic solutions here.

¹SmartTrak, 2023 – U.S. External Fixation Market Overview.

About Orthofix

The newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Its products are distributed in more than 68 countries worldwide.

The Company is headquartered in Lewisville, Texas and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France, and São Paulo, Brazil.

Forward-Looking Statements

This news release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “continue” or other comparable terminology. Orthofix cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6, 2023. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Orthofix does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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