Orthofix Receives 510(k) Clearance and CE Mark for TrueLok Elevate Transverse Bone Transport System
Orthofix Medical Inc. (NASDAQ:OFIX) has received both FDA 510(k) clearance and European CE Mark for its TrueLok™ Elevate Transverse Bone Transport (TBT) System, marking a significant advancement in limb preservation treatment.
The system, currently in market release in the U.S. and select international markets, addresses bony and soft tissue deformities, including diabetic foot ulcers and nonhealing wounds. It is the first FDA-cleared dedicated system for TBT procedures, enabling surgeons to create and gradually distract bone segments in the tibia.
This innovation targets a $1.2 billion market opportunity, addressing the over 160,000 annual diabetic-related amputations in the U.S. Studies show patients with diabetic foot ulcers who undergo amputation face a 57% five-year mortality rate and lifetime healthcare costs exceeding $640,000 for amputation-related care.
Orthofix Medical Inc. (NASDAQ:OFIX) ha ricevuto sia l'approvazione FDA 510(k) che il Marchio CE europeo per il suo TrueLok™ Elevate Transverse Bone Transport (TBT) System, segnando un avanzamento significativo nel trattamento per la preservazione degli arti.
Il sistema, attualmente in fase di rilascio sul mercato negli Stati Uniti e in alcuni mercati internazionali selezionati, affronta le deformità ossee e dei tessuti molli, inclusi gli ulcere del piede diabetico e le ferite non guarenti. È il primo sistema dedicato per le procedure TBT ad essere approvato dalla FDA, consentendo ai chirurghi di creare e distrarre gradualmente i segmenti ossei nella tibia.
Questa innovazione mira a un mercato da 1,2 miliardi di dollari, affrontando oltre 160.000 amputazioni annuali correlate al diabete negli Stati Uniti. Studi mostrano che i pazienti con ulcere del piede diabetico che subiscono un'amputazione affrontano un tasso di mortalità del 57% a cinque anni e costi sanitari a vita superiori a $640.000 per le cure legate all'amputazione.
Orthofix Medical Inc. (NASDAQ:OFIX) ha recibido la aprobación 510(k) de la FDA y el Marcado CE europeo para su TrueLok™ Elevate Transverse Bone Transport (TBT) System, marcando un avance significativo en el tratamiento de preservación de extremidades.
El sistema, que actualmente se encuentra en lanzamiento en el mercado de EE. UU. y en algunos mercados internacionales seleccionados, aborda deformidades óseas y de tejidos blandos, incluidas las úlceras del pie diabético y heridas que no sanan. Es el primer sistema dedicado para procedimientos TBT que ha sido aprobado por la FDA, permitiendo a los cirujanos crear y distraer gradualmente segmentos óseos en la tibia.
Esta innovación apunta a una oportunidad de mercado de 1.2 mil millones de dólares, abordando más de 160,000 amputaciones anuales relacionadas con la diabetes en EE. UU. Los estudios muestran que los pacientes con úlceras del pie diabético que se someten a una amputación enfrentan una tasa de mortalidad del 57% a cinco años y costos de atención médica de por vida que superan los $640,000 para el cuidado relacionado con la amputación.
Orthofix Medical Inc. (NASDAQ:OFIX)는 TrueLok™ Elevate Transverse Bone Transport (TBT) System에 대해 FDA 510(k) 승인과 유럽 CE 마크를 모두 획득하여 사지 보존 치료의 중요한 발전을 이뤘습니다.
현재 미국 및 일부 국제 시장에서 출시되고 있는 이 시스템은 당뇨병성 발 궤양 및 치유되지 않는 상처를 포함한 뼈 및 연조직 기형을 해결합니다. TBT 절차를 위한 FDA 승인을 받은 최초의 전용 시스템으로, 외과의사가 경골의 뼈 조각을 생성하고 점진적으로 분리할 수 있도록 합니다.
이 혁신은 12억 달러의 시장 기회를 목표로 하며, 미국에서 매년 160,000건 이상의 당뇨병 관련 절단을 다룹니다. 연구에 따르면 당뇨병성 발 궤양이 있는 환자가 절단을 받을 경우 5년 사망률이 57%에 달하며, 절단 관련 치료에 대한 평생 의료비용은 640,000달러를 초과합니다.
Orthofix Medical Inc. (NASDAQ:OFIX) a obtenu à la fois l'approbation FDA 510(k) et le marquage CE européen pour son TrueLok™ Elevate Transverse Bone Transport (TBT) System, marquant une avancée significative dans le traitement de la préservation des membres.
Le système, actuellement en phase de lancement sur le marché américain et dans certains marchés internationaux sélectionnés, traite les déformations osseuses et des tissus mous, y compris les ulcères du pied diabétique et les plaies non cicatrisantes. C'est le premier système dédié aux procédures TBT à avoir reçu l'approbation de la FDA, permettant aux chirurgiens de créer et de distraire progressivement des segments osseux dans le tibia.
Cette innovation vise une opportunité de marché de 1,2 milliard de dollars, en réponse à plus de 160 000 amputations annuelles liées au diabète aux États-Unis. Des études montrent que les patients atteints d'ulcères du pied diabétique qui subissent une amputation font face à un taux de mortalité de 57 % sur cinq ans et des coûts de soins de santé à vie dépassant 640 000 $ pour les soins liés à l'amputation.
Orthofix Medical Inc. (NASDAQ:OFIX) hat sowohl die FDA 510(k)-Zulassung als auch das europäische CE-Zeichen für sein TrueLok™ Elevate Transverse Bone Transport (TBT) System erhalten, was einen bedeutenden Fortschritt in der Behandlung zur Erhaltung von Gliedmaßen darstellt.
Das System, das derzeit auf dem Markt in den USA und in ausgewählten internationalen Märkten erhältlich ist, behandelt Knochendeformitäten und Weichgewebsdeformitäten, einschließlich diabetischer Fußgeschwüre und nicht heilender Wunden. Es ist das erste von der FDA genehmigte System, das speziell für TBT-Verfahren entwickelt wurde, und ermöglicht es Chirurgen, Knochensegmente in der Tibia zu erstellen und schrittweise zu dehnen.
Diese Innovation zielt auf eine Marktchance von 1,2 Milliarden Dollar ab und adressiert über 160.000 jährliche amputationsbedingte Diabetesfälle in den USA. Studien zeigen, dass Patienten mit diabetischen Fußgeschwüren, die sich einer Amputation unterziehen, eine fünfjährige Sterblichkeitsrate von 57% haben und die lebenslangen Gesundheitskosten für amputationsbedingte Pflege über 640.000 Dollar betragen.
- First FDA-cleared dedicated system for Transverse Bone Transport procedures
- Addresses $1.2 billion market opportunity in diabetic-related amputations
- Potential to reduce healthcare costs compared to $640,000 lifetime amputation-related expenses
- Dual regulatory approval (FDA and CE Mark) expanding market access
- market release indicates restricted revenue potential in short term
Insights
Orthofix's FDA 510(k) clearance and CE Mark for their TrueLok Elevate system represents a significant regulatory milestone that positions the company to address a substantial unmet medical need. As the first dedicated system for Transverse Bone Transport to receive FDA clearance, this device establishes Orthofix as a pioneer in this specific application of external fixation technology.
The clinical significance is substantial - this system offers an alternative to amputation for diabetic foot ulcers and non-healing wounds by improving blood circulation through a controlled bone transport process. The mortality implications cannot be overstated - patients with diabetic-related amputations face a staggering 57% five-year mortality rate.
From a market perspective, this approval taps into a $1.2 billion opportunity addressing over 160,000 annual diabetic-related amputations in the US alone. The system's dual regulatory clearances (US and Europe) enable multi-market commercialization, though investors should note the current market release status signals a measured rollout approach rather than immediate widespread availability.
This approval strengthens Orthofix's position in the limb reconstruction sector, complementing their existing TrueLok product family while expanding their therapeutic reach into diabetic limb preservation - a high-value clinical area with significant payer interest given the $640,000 lifetime healthcare costs associated with each amputation.
This regulatory approval enhances Orthofix's competitive positioning in the high-margin external fixation segment. The TrueLok Elevate system targets a $1.2 billion addressable market opportunity specifically in diabetic-related amputations, providing a material growth vector for the company's Global Orthopedics division.
The economic value proposition is compelling from a payer perspective - with $640,000 in lifetime costs associated with each amputation, insurers have strong financial incentives to reimburse limb-preserving technologies that demonstrate clinical efficacy. This favorable reimbursement landscape should support adoption once the company expands beyond the current market release.
While revenue contribution will be modest initially due to the controlled rollout approach, this approval represents a meaningful portfolio expansion in Orthofix's core external fixation business. The company is strategically targeting the intersection of multiple high-growth segments: limb preservation, deformity correction, limb lengthening, and complex fracture management.
The dual regulatory approvals (FDA and CE Mark) provide maximum geographic flexibility as Orthofix executes its commercialization strategy. Investors should view this as part of the company's broader strategy to establish leadership in limb reconstruction with proprietary technologies that address critical clinical needs while delivering favorable economics to healthcare systems.
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
“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
According to the American Diabetes Association, over 160,000 amputations occur per year in the
“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
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
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
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