Orthofix Announces Global Commercial Launch of the TrueLok Elevate Transverse Bone Transport System

Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced the global commercial launch of the TrueLok™ Elevate Transverse Bone Transport (TBT) System. TrueLok Elevate represents the first commercially available device in the U.S. with a patented design for use in the TBT procedure to provide a limb preservation treatment option for addressing bony or soft tissue deformities or defects, such as diabetic ulcers.

“I have been using the TrueLok Elevate System in my practice to treat patients with ulcers and other ischemic conditions and am pleased by the results I have observed so far,” said Victor Anciano, M.D., a foot and ankle surgeon in Louisville, KY, who has used TrueLok Elevate during the limited market release. “The system offers a reproducible, streamlined surgical approach as well as easy adjustability for the patient. I look forward to continuing to integrate this product into my practice to best treat patients who are at risk of losing their limb.”

Diabetes mellitus is projected to affect 11% of the global population (700 million people) by 2045.¹ According to the American Diabetes Association, over 160,000 amputations occur each year in the U.S. as a result of diabetic-related complications, representing a sizable market opportunity of approximately $1.2 billion.² In addition, published studies have shown that patients with diabetic foot ulcers who receive an amputation have a five-year mortality rate of 57% and are burdened with lifetime healthcare costs of just over $640,000 for care directly related to their amputation.³^,⁴ Therefore, TrueLok Elevate offers the potential to be a limb- and cost-saving device for a rapidly-growing patient population.

“The success of the TrueLok Elevate System during the limited market release advances our strategy to become the leading limb reconstruction company in the market, and in particular, expands our presence in the growing diabetic wound market with an innovative solution designed to address a challenging patient population and potentially reduce the burden of complications associated with soft tissue defects including ulcers,” said Patrick Fisher, President of Global Orthopedics for Orthofix. “We are committed to redefining the category of limb reconstruction through further innovation to ensure that our unique portfolio of industry-leading products continues to empower surgeons to excel in limb preservation, extremity deformity correction, limb lengthening and complex fracture management.”

The TrueLok Elevate System represents the latest addition to Orthofix’s flagship product line, the TrueLok family of multiplanar external fixators, including the TrueLok EVO and TL-HEX™ ring fixation systems. Since receiving FDA clearance and CE registration earlier this year, over 130 TrueLok Elevate procedures have been completed globally under a limited market release.

For indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the Instructions for Use or contact your local representative. Additional information about Orthofix’s full line of orthopedic solutions is available on Orthofix.com.

Internet Posting of Information

Orthofix routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.orthofix.com. Orthofix encourages investors and potential investors to consult the Orthofix website regularly for important information about Orthofix.

About Orthofix

Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, we deliver exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics and enabling technologies, including the 7D FLASH™ navigation system. To learn more, visit Orthofix.com and follow on LinkedIn.

References:

1. Maguire, B. “Europe’s amputation crisis, diabetes experts call for urgent new screening programs.” Euractiv’s Advocacy Lab May 1, 2024
2. https://diabetes.org/advocacy/amputation-prevention-alliance
3. Vuorlaakso, M et al. “Major Amputation Profoundly Increases Mortality in Patients With Diabetic Foot Infection.” Frontiers in Surgery vol. 8 655902. 30 Apr. 2021, doi:10.3389/fsurg.2021.655902
4. Palli, S et al. “Impact of a Limb Salvage Program on the Economic Burden of Amputation in the United States.” Value in Health vol. 19(3):A45. May 2016, doi:10.1016/j.jval.2016.03.098

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 Orthofix’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, 2024, which was filed with the Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent Quarterly Report on Form 10-Q or Current Report on Form 8-K filed with the SEC. Orthofix’s public filings with the SEC 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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