Orthofix Receives 510(k) Clearance and CE Mark for TrueLok Elevate Transverse Bone Transport System

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok^™ Elevate Transverse Bone Transport (TBT) System.

TrueLok™ Elevate Transverse Bone Transport (TBT) System

TrueLok Elevate provides a limb preservation treatment option for addressing bony or soft tissue deformities and defects such as diabetic foot ulcers and nonhealing or deep tissue wounds. While the TBT procedure has previously been reported,¹ TrueLok Elevate is the first dedicated system for TBT to receive FDA clearance. The product is currently available in a limited market release in the U.S. and select international markets.

“Transverse bone transport with TrueLok Elevate now enables surgeons to effectively address challenging conditions in a patient’s extremity by allowing for an efficient and reproducible method to create a bone segment in the tibia that can then be gradually distracted over a period of several days,” said Dr. Emmy Oji, a podiatric foot and ankle surgeon at Valley Foot and Ankle Specialty Providers, who was among the first surgeons to apply the TrueLok Elevate system to a patient. “Clinical publications have shown this approach improves blood circulation to the affected limb and promotes wound healing in diabetic foot, potentially reducing the need for amputation.” Additionally, first patient cases in Europe were performed in the UK and Germany.

According to the American Diabetes Association, over 160,000 amputations occur per year in the U.S. as a result of diabetic-related complications, representing a sizable market opportunity of approximately $1.2 billion. 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.^2,3 Therefore, TrueLok Elevate offers the potential to not only be a limb and cost-saving device, but most importantly, a life-saving solution to a challenging patient population.

“The introduction of the TrueLok Elevate system is a pivotal milestone in demonstrating our commitment to leading growth in the limb reconstruction market,” said Patrick Fisher, President of Global Orthopedics for Orthofix. “Within our orthopedics business, we are focusing on providing innovative solutions that spans four pillars: Limb Preservation, Extremity Deformity Correction, Limb Lengthening, and Complex Fracture Management to aid surgeons in managing patients with complex limb reconstruction needs.”

Those attending the American College of Foot & Ankle Surgeons (ACFAS) Annual Scientific Conference in Phoenix, AZ from March 27-30 can learn more about the TrueLok Elevate System by visiting booth 1045.

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. 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.

References:

1. Chen, Yan et al. “Effect of tibial cortex transverse transport in patients with recalcitrant diabetic foot ulcers: A prospective multicenter cohort study.” Journal of orthopaedic translation vol. 36 194-204. 12 Oct. 2022, doi:10.1016/j.jot.2022.09.002

2. Vuorlaakso, Miska 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

3. 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 Issue 3, A45

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 Orthofix on LinkedIn.

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, 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. The Company’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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Investors and Media

Julie Dewey, IRC

Chief Investor Relations & Communications Officer

JulieDewey@orthofix.com

209.613.6945

Source: Orthofix Medical Inc.

FAQ

What regulatory approvals has Orthofix (OFIX) received for the TrueLok Elevate system?

Orthofix has received both FDA 510(k) clearance and European CE Mark for the TrueLok Elevate Transverse Bone Transport System.

What is the market opportunity for Orthofix's (OFIX) TrueLok Elevate system in the US?

The system addresses a $1.2 billion market opportunity, targeting over 160,000 annual diabetic-related amputations in the U.S.

What are the healthcare costs associated with diabetic amputations that OFIX's TrueLok system aims to prevent?

Patients with diabetic foot ulcers who receive amputations face lifetime healthcare costs of over $640,000 for amputation-related care.

What is the current availability status of OFIX's TrueLok Elevate system?

The system is currently available in a market release in the United States and select international markets.

What is the mortality rate for diabetic patients who undergo amputation that OFIX's TrueLok system targets?

Patients with diabetic foot ulcers who receive an amputation have a five-year mortality rate of 57%.