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What changed in Orthofix Medical Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Orthofix Medical Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+391 added−398 removedSource: 10-K (2026-02-24) vs 10-K (2025-02-25)

Top changes in Orthofix Medical Inc.'s 2025 10-K

391 paragraphs added · 398 removed · 344 edited across 2 sections

Item 1. Business

Business — how the company describes what it does

145 edited+23 added−20 removed102 unchanged
Biggest changeOur key strategies in this segment are: • Expand our position as the worldwide leader in limb reconstruction, including both internal and external solutions, through a patient-centric approach and digital treatment journey; • Leverage our cross-product OrthoNext digital platform, a uniquely developed pre and post planning, software that allows our clinicians to pre-plan surgery for patients so they can start surgeries with a greater degree of confidence, reduce surgical times, enable better outcomes, and follow up post operatively to evaluate the success of the chosen surgical plan; • Build on our historical position as a company at the forefront of innovation in the management of Charcot foot and ankle conditions by further investing into limb preservation technology advancements that address challenging conditions associated with diabetic foot; • Promote and invest in our Fitbone intramedullary limb lengthening platform, including the newly released Transport and Lengthening System – the only all internal bone transport intramedullary nail available in the U.S.; • Continue to be market leaders in deformity correction with our flagship TrueLok system, comprised of the most comprehensive external ring fixation solutions, and focusing on delivering enabling technology solutions to improve surgeons' ability to effectively treat their patients; • Continue to focus on complex fracture management in select global markets, with the Galaxy Fixation System and by providing single-use sterile pack procedural solutions to reduce costs and drive surgical efficiencies; • Collaborate with physicians and healthcare partners to improve patients’ lives through digitally transformative technology, clinical evidence, and our industry-leading medical education program, Orthofix Academy; • Continue the strong pace of new product launches; and • Acquire or license products, technologies, and companies to support these market opportunities.
Biggest changeOur key strategies in this segment are: • expand our position as the worldwide leader in limb reconstruction through a patient-centric approach that is able to leverage internal and external fixation devices and digital treatment solutions; • leverage our cross-product OrthoNext digital platform, a unique pre- and postoperative planning software platform developed to allow clinicians to plan procedures in advance, improving surgical preparedness, reducing operating time, enhancing outcomes, and supporting postoperative evaluation; 14 • build on our historical position as a company at the forefront of innovation in the management of Charcot foot and ankle conditions by further investing in limb preservation technology advancements that address challenging conditions associated with diabetic foot; • promote and invest in our Fitbone intramedullary limb lengthening platform, including the newly released Fitbone Transport and Lengthening System – the only all internal bone transport intramedullary nail available in the U.S.; • continue to be market leaders in deformity correction with our flagship TrueLok system, comprised of the most comprehensive external ring fixation solutions, and focusing on delivering enabling technology solutions to improve surgeons' ability to effectively treat their patients; • promote and invest in our TrueLok external fixation product platform, including the recently launched TrueLok Elevate System; • continue to focus on complex fracture management in select global markets, with the Galaxy Fixation System and by providing single-use sterile pack procedural solutions to reduce costs and drive surgical efficiencies; • collaborate with physicians and healthcare partners to improve patients’ lives through digitally transformative technology, clinical evidence, and our industry-leading medical education platform, Orthofix Academy; • continue the strong pace of new product launches; and • acquire or license products and, technologies, and acquire or collaborate with other entities to support these market opportunities.
Available Information and Orthofix Website Our filings with the Securities and Exchange Commission ("SEC"), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Proxy Statements for Meetings of Shareholders, registration statements, and amendments to those reports, are available free of charge on our website as soon as reasonably practicable after they are filed with, or furnished to, the SEC.
Available Information and Orthofix Website Our filings with the Securities and Exchange Commission ("SEC"), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Proxy Statements for Meetings of Shareholders, registration statements, and amendments to those filings, are available free of charge on our website as soon as reasonably practicable after they are filed with, or furnished to, the SEC.
PhysioStim Bone Healing Therapy PEMF non-invasive appendicular skeleton healing therapy used to enhance bone growth in nonunion fractures. AccelStim LIPUS healing therapy used to enhance bone growth in certain fresh, distal radius, and tibial diaphysis fractures and nonunion fractures.
PhysioStim Bone Healing Therapy PEMF non-invasive appendicular skeleton healing therapy used to enhance bone growth in nonunion fractures. AccelStim Bone Healing Therapy LIPUS healing therapy used to enhance bone growth in certain fresh, distal radius, and tibial diaphysis fractures and nonunion fractures.
Jazz Bands provide a temporary short-term stabilization as a bond anchor to aid in the repair of bone fractures. 7D FLASH Navigation System (Spine) A machine-vision navigation platform for use in open and mini-open posterior spinal procedures that uses proprietary visible light technology coupled with advanced software algorithms to deliver a fast, efficient, cost-effective, and radiation free solution for spine surgery. 7D FLASH Navigation System (Percutaneous) A valuable enhancement to the 7D FLASH Navigation System to address percutaneous spinal procedures; the camera-based technology, coupled with 7D Machine Vision algorithms, maintains the same fast, accurate, and efficient surgical workflow as the Spine platform, while also providing an imaging agnostic solution to percutaneous posterior spine surgery. 7D FLASH Navigation System (Cranial) A module on the 7D FLASH Navigation System that utilizes 7D Machine Vision Technology for cranial surgery; the visible light technology allows for a completely contactless workflow, acquires hundreds of thousands of virtual fiducials using the patient’s own anatomy, and results in nearly instantaneous cranial registrations to the skin or skull in almost any surgical position.
Jazz Bands provide a temporary short-term stabilization as a bond anchor to aid in the repair of bone fractures. 7D FLASH Navigation System (Spine) A machine-vision navigation platform for use in open and mini-open posterior spinal procedures that uses proprietary visible light technology coupled with advanced software algorithms to deliver a fast, efficient, cost-effective, and radiation free solution for spine surgery. 7D FLASH Navigation System (Percutaneous) A valuable enhancement to the 7D FLASH Navigation System to address percutaneous spinal procedures; the camera-based technology, coupled with proprietary machine vision algorithms, maintains the same fast, accurate, and efficient surgical workflow as the spine platform, while also providing an imaging agnostic solution to percutaneous posterior spine surgery. 7D FLASH Navigation System (Cranial) A module on the 7D FLASH Navigation System that utilizes machine vision technology for cranial surgery; the visible light technology allows for a completely contactless workflow, acquires hundreds of thousands of virtual fiducials using the patient’s own anatomy, and results in nearly instantaneous cranial registrations to the skin or skull in almost any surgical position.
Furthermore, we believe that the previous research work with Cleveland Clinic, the Chinese University of Hong Kong, and the University of Pennsylvania, allowing for characterization and demonstration of the Orthofix new PEMF waveform, is paving the way for signal optimization for a variety of new applications and indications.
Furthermore, we believe that the previous research work with Cleveland Clinic, The Chinese University of Hong Kong, and University of Pennsylvania, allowing for characterization and demonstration of the Orthofix new PEMF waveform, is paving the way for signal optimization for a variety of new applications and indications.
TrueLok Hexapod System ("TL-HEX") A hexapod external fixation system for deformity correction with associated software newly integrated into the OrthoNext platform, designed as a three-dimensional bone segment reposition module to augment the previously developed TrueLok frame.
TrueLok Hexapod ("TL-HEX") System A hexapod external fixation system for deformity correction with associated software newly integrated into the OrthoNext platform, designed as a three-dimensional bone segment reposition module to augment the previously developed TrueLok frame.
These regulatory requirements include: product listing and establishment registration; Quality System Regulation ("QSR"), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the manufacturing process; labeling regulations and governmental prohibitions against the promotion of products for uncleared, unapproved, or off-label uses or indications; clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices; approval of product modifications that affect the safety or effectiveness of one of our PMA approved devices; Medical Device Adverse Event Reporting regulations, which require that manufacturers report to the FDA and other foreign governmental agencies if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur; post-approval restrictions or conditions, including post-approval study commitments; post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device; the FDA’s recall authority, whereby it can ask, or under certain conditions, order device manufacturers to recall a product from the market that is in violation of governing laws and regulations; regulations pertaining to voluntary recalls; and notices of corrections or removals.
These regulatory requirements include: product listing and establishment registration; Quality System Regulation ("QSR"), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the manufacturing process; labeling regulations and governmental prohibitions against the promotion of products for uncleared, unapproved, or off-label uses or indications; clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices; approval of product modifications that affect the safety or effectiveness of one of our PMA approved devices; Medical Device Adverse Event Reporting regulations, which require that manufacturers report to the FDA and other foreign governmental agencies if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur; post-approval restrictions or conditions, including post-approval study commitments; post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device; the FDA’s recall 20 authority, whereby it can ask, or under certain conditions, order device manufacturers to recall a product from the market that is in violation of governing laws and regulations; regulations pertaining to voluntary recalls; and notices of corrections or removals.
For a further discussion of these risks, please see Item 1A of this Annual Report under the heading "Risk Factors." We rely on confidentiality and non-disclosure agreements with employees, consultants, and other parties to protect, in part, trade secrets and other proprietary technology. We obtain assignments or licenses of varying durations for certain of our products from third parties.
For further discussion of these risks, please see Item 1A of this Annual Report under the heading "Risk Factors." We rely on confidentiality and non-disclosure agreements with employees, consultants, and other parties to protect, in part, trade secrets and other proprietary technology. We obtain assignments or licenses for varying durations for certain of our products from third parties.
We also partner with MTF Biologics to provide our customers allograft solutions (HCT/Ps) for various spine, orthopedic and other bone repair needs. MTF Biologics provides donor screening, processing, and quality standards that are expected by our customers. Our partnership with MTF allows us to exclusively market the Virtuos Lyograft, Trinity ELITE, FiberFuse and FiberFuse Strip, and certain other tissue forms.
We also partner with MTF to provide our customers allograft solutions (HCT/Ps) for various spine, orthopedic and other bone repair needs. MTF provides donor screening, processing, and quality standards that are expected by our customers. Our partnership with MTF allows us to exclusively market the Virtuos Lyograft, Trinity Elite, FiberFuse and FiberFuse Strip, and certain other tissue forms.
Regarding our Bone Growth Therapy business, we have participated in research at the Wake Forest University Health Sciences, Chinese University of Hong Kong, and University of California San Francisco, where scientists conducted animal and cellular studies 14 to identify the mechanisms of action of our PEMF signals on bone, cartilage, meniscus, nerve, and efficacy of healing.
Regarding our Bone Growth Therapy business, we have participated in research at Wake Forest University Health Sciences, The Chinese University of Hong Kong, and University of California San Francisco, where scientists conducted animal and cellular studies to identify the mechanisms of action of our PEMF signals on bone, cartilage, meniscus, nerve, and efficacy of healing.
In addition to these options, we also offer several different disc and endplate preparation options to satisfy the ACDF procedure. Revision Surgical Procedures As an adjunct to our posterior lumbar fixation portfolio, we offer two main products, Mariner Outrigger and Connectors, that are designed to help surgeons tackle difficult revision cases.
In addition to these options, we also offer several different disc and endplate preparation options to satisfy the ACDF procedure. 9 Revision Surgical Procedures As an adjunct to our posterior lumbar fixation portfolio, we offer two main products, Mariner Outrigger and Connectors, that are designed to help surgeons tackle difficult revision cases.
The Company was founded in Verona, Italy in 1980 and formally incorporated in 1987 in Curaçao as "Orthofix International N.V." In 2018, we completed a change in our jurisdiction of organization from Curaçao to the State of Delaware (the "Domestication") and changed our name to "Orthofix Medical Inc." As a result, we are a corporation existing under the laws of the State of Delaware.
The Company was founded in Verona, Italy in 1980 and formally incorporated in 1987 in Curaçao as "Orthofix International N.V." In 2018, we completed a change in our jurisdiction of organization from Curaçao to the State of Delaware and changed our name to "Orthofix Medical Inc." As a result, we are a corporation existing under the laws of the State of Delaware.
The system consists of circular and semi-circular external supports, secured to the bones by wires and half pins and interconnected by six struts, which allows multi-planar adjustment of the external supports. The rings’ positions are adjusted either rapidly or gradually in precise increments to perform bone segment repositioning in three-dimensional space.
The system consists of circular and semi-circular external supports, secured to the bones by wires and half pins and interconnected by six struts, which allows for multi-planar adjustment of the external supports. The rings’ positions are adjusted either rapidly or gradually in precise increments to perform bone segment repositioning in three-dimensional space.
The amount of time required to obtain approvals or clearances from regulatory authorities also differs from country to country. Unless an exemption applies, each medical device we commercially distribute in the U.S. is covered by premarket notification ("510(k)") clearance, letter to file, or approval of a premarket approval application ("PMA").
The amount of time required to obtain approvals or clearances from regulatory authorities also differs from country to country. Unless an exemption applies, each medical device we commercially distribute in the U.S. is covered by premarket notification ("510(k)") clearance, letter to file, or approval of a PMA.
Failure to meet the requirements of the regulation could adversely impact our business in the E.U. and other countries that utilize or rely on E.U. requirements for medical device registrations. 19 In the E.U., our products that contain human-derived tissue, including demineralized bone material, are not medical devices as defined in the MDR.
Failure to meet the requirements of the regulation could adversely impact our business in the E.U. and other countries that utilize or rely on E.U. requirements for medical device registrations. In the E.U., our products that contain human-derived tissue, including demineralized bone material, are not medical devices as defined in the MDR.
For a further description of some of the risks associated with matters described above, see Item 1A of this Annual Report under the heading "Risk Factors." 20 Certain Other Product and Manufacturing Regulations After a device is placed in the market, numerous regulatory requirements continue to apply.
For a further description of some of the risks associated with matters described above, see Item 1A of this Annual Report under the heading "Risk Factors." Certain Other Product and Manufacturing Regulations After a device is placed in the market, numerous regulatory requirements continue to apply.
LRS Advanced Limb Reconstruction System An external fixation solution for limb lengthening and deformity correction, that uses callus distraction to lengthen bone in a variety of procedures, 16 including bone transport, simultaneous compression and distraction at different sites, bifocal lengthening, and correction of deformities with shortening.
LRS Advanced Limb Reconstruction System An external fixation solution for limb lengthening and deformity correction, that uses callus distraction to lengthen bone in a variety of procedures, including bone transport, simultaneous compression and distraction at different sites, bifocal lengthening, and correction of deformities with shortening.
Within our Biologics product category, we market tissue for bone repair and reconstruction, an allogeneic bone matrix comprised of cancellous bone containing viable cells and a demineralized cortical bone component, as well as, demineralized cortical fibers, structural allografts, and an amniotic membrane, which is a natural tissue barrier.
Within our Biologics product category, we market tissue for bone repair and reconstruction, an allogeneic bone matrix comprised of cancellous bone containing viable cells and a demineralized cortical bone component, as well as, demineralized cortical fibers, 19 structural allografts, and an amniotic membrane, which is a natural tissue barrier.
Several devices in our portfolio utilize our patented pulsed electromagnetic field ("PEMF") technology, the safety and efficacy of which is supported by basic mechanism of action data in the scientific literature, as well as published data from level one randomized controlled clinical trials.
Several devices in our portfolio utilize our pulsed electromagnetic field ("PEMF") technology, the safety and efficacy of which is supported by basic mechanism of action data in the scientific literature, as well as published data from level one randomized controlled clinical trials.
Laws Protecting the Confidentiality of Health Information U.S. federal and state laws protect the confidentiality of certain health information, in particular individually identifiable information such as medical records, and restrict the use and disclosure of that protected information. At the federal level, the HHS promulgates health information privacy and security rules under HIPAA.
Laws Protecting the Confidentiality of Health Information U.S. federal and state laws protect the confidentiality of certain health information, in particular individually identifiable information such as medical records, and restrict the use and disclosure of that protected information. At the federal level, the 21 HHS promulgates health information privacy and security rules under HIPAA.
Designed for use with smartphones and other mobile devices, the STIM onTrack tool helps patients follow their prescription with daily treatment reminders and a device usage calendar. The app is free and available through the Android and Apple App Stores.
Designed for use with smartphones and other mobile devices, the STIM onTrack app helps patients follow their prescription with daily treatment reminders and a device usage calendar. The app is free and available through the Android and Apple App Stores.
While we make extensive efforts to ensure that our products do not infringe other parties’ patents and proprietary rights, our products and methods may be found by a court to be covered by patents held by our competitors or other third parties.
While we make extensive efforts to ensure that our products do not infringe other parties’ patents and proprietary rights, our products, technology, and methods may be found by a court to be covered by patents held by our competitors or other third parties.
The chart below presents reported net sales, which includes product sales and marketing service fees, by reporting segment for each of the years ended December 31, 2024, 2023, and 2022. 6 Financial information regarding our reportable business segments and certain geographic information is included in Part II, Item 7 of this Annual Report under the heading "Management’s Discussion and Analysis of Financial Condition and Results of Operations," and Note 16 of the Notes to the Consolidated Financial Statements in Item 8 of this Annual Report.
The chart below presents reported net sales, which includes product sales and marketing service fees, by reporting segment for each of the years ended December 31, 2025, 2024, and 2023. 6 Financial information regarding our reportable business segments and certain geographic information is included in Part II, Item 7 of this Annual Report under the heading "Management’s Discussion and Analysis of Financial Condition and Results of Operations," and Note 16 of the Notes to the Consolidated Financial Statements in Item 8 of this Annual Report.
FLASH External Ventricular Drain ("EVD") System (Cranial) The FLASH EVD system leverages proprietary LiveTrack Machine Vision hardware and software to generate high-resolution three-dimensional images embedded with hundreds of thousands of virtual fiducials.
FLASH External Ventricular Drain ("EVD") System (Cranial) The FLASH EVD System leverages LiveTrack, our proprietary machine vision hardware and software to generate high-resolution three-dimensional images embedded with hundreds of thousands of virtual fiducials.
Global Orthopedics Strategy Our strategy for the Global Orthopedics reporting segment has recently evolved to specifically focus on providing unrivaled limb reconstruction procedural solutions coupled with first-in-class service and support.
Global Limb Reconstruction Strategy Our strategy for the Global Limb Reconstruction reporting segment has recently evolved to specifically focus on providing unrivaled limb reconstruction procedural solutions coupled with first-in-class service and support.
OSCAR An ultrasonic powered surgical system for revision hip and knee arthroplasty. External Fixators External fixation, including our limb-lengthening systems, ProCallus, XCaliber, Pennig, Radiolucent Wrist Fixators, and Calcaneal Fixator.
OSCAR An ultrasonic powered surgical system for revision hip and knee arthroplasty. External Fixators External fixation, including our limb-lengthening systems, ProCallus, XCaliber, Pennig, Radiolucent Wrist Fixators, and Calcaneal Fixators.
DOJ") ("Evaluation of Corporate Compliance Programs" (updated March 2023)), the Office of 18 Inspector General (HCCA-OIG "General Compliance Program Guidance" (November 2023)), and the U.S. Sentencing Commission ("Effective Compliance and Ethics Programs" (November 2014)).
DOJ") ("Evaluation of Corporate Compliance Programs" (updated March 2023)), the Office of Inspector General (HCCA-OIG "General Compliance Program Guidance" (November 2023)), and the U.S. Sentencing Commission ("Effective Compliance and Ethics Programs" (November 2014)).
We typically acquire rights under such assignments or licenses in exchange for lump-sum payments or arrangements under which we pay a percentage of sales to the licensor.
We typically acquire rights under such assignments or licenses in exchange for lump-sum payments or arrangements under which we pay a percentage of sales to the assignor or licensor.
TrueLok EVO A modular circular external fixation system, available pre-assembled in sterile kits for complex fracture management, deformity correction, and limb preservation; it is the only circular fixation system to feature both radiolucent rings and struts that provides surgeons with clear radiographic visualization to better assess bone anatomy both during surgery and in post-operative care.
TrueLok EVO System A modular circular external fixation system, available pre-assembled in sterile kits for complex fracture management, deformity correction, and limb preservation; it is the only circular fixation system to feature both radiolucent rings and struts that provide surgeons with clear radiographic visualization to better assess bone anatomy both during surgery and in post-operative care.
It is indicated for patients at high-risk for non-fusion. The SpinalStim and CervicalStim systems are accompanied by an application for mobile devices called STIM onTrack. The mobile app includes a first-to-market feature that enables physicians to remotely view patient adherence to prescribed treatment protocols and patient reported outcome measures.
It is indicated for patients at high-risk for non-fusion. The SpinalStim and CervicalStim devices are accompanied by an application for mobile devices called STIM onTrack. This mobile app includes a first-to-market feature that enables physicians to remotely view patient adherence to prescribed treatment protocols and patient reported outcome measures.
Our anterior lumbar portfolio has several different footprints and lordotic options as well as options for integrated fixation or plating. These brands include Waveform A, Reef A, Pillar SA PTC, Unity Lumbosacral Plating, and Meridian. Our lateral portfolio takes full advantage of our top-of-the-line retractor systems to gain access to the disc space.
Our anterior lumbar portfolio has several different footprints and lordotic options as well as options for integrated fixation or plating. These brands include Waveform A, Reef A, Pillar SA PTC, and Meridian. Our lateral portfolio takes full advantage of our top-of-the-line retractor systems to gain access to the disc space.
These allografts are regulated under the FDA’s Human Cell, Tissues and Cellular and Tissue-Based Products ("HCT/P") regulatory paradigm and not as a medical device, biologic, or a drug. These tissues are regulated by the FDA as minimally-manipulated tissue and are covered by the FDA’s "Good Tissues Practices" regulations, which cover all stages of allograft processing.
These allografts are regulated under the FDA’s Human Cell, Tissues and Cellular and Tissue-Based Products ("HCT/P") regulatory paradigm and not as a medical device, biologic, or drug. These tissues are regulated by the FDA as minimally-manipulated tissue and are covered by the FDA’s "Good Tissue Practice" regulations, which cover all stages of allograft processing.
Our largest portfolio of products is within DBMs, which includes both putty and fiber-based forms that provide different handling and performance based on clinical applications. Leading this portfolio are Strand Plus, 100% DBM Fiber with Accell, Evo3/Evo3c, and DBM putty with Accell. ABM is a key differentiator within the DBM market.
Our largest portfolio of products is within DBMs, which includes both putty and fiber-based forms that provide different handling and performance based on clinical applications. Leading the DMB portfolio are Strand Plus, 100% DBM fiber with Accell, Evo3/Evo3c, and DBM putty with Accell. ABM is a key differentiator within the DBM market.
In addition to our allograft solutions (HCT/Ps), we market and distribute additional demineralized bone putties, resorbable mesh with demineralized particulates, and synthetic putties and strips that are regulated by the FDA as medical devices. We also provide ancillary technologies regulated by the FDA as medical devices that aid in the delivery of our bone grafting options clinically.
In addition to our allograft solutions (HCT/Ps), we market and distribute additional demineralized bone putties, resorbable mesh with demineralized particulates, and synthetic putties and strips that are regulated by the FDA as medical devices. We also provide ancillary technologies regulated by the FDA as medical devices that aid in the surgical delivery of our bone grafting options.
Sacroiliac ("SI") Joint Fusion Procedures Firebird SI is a minimally invasive screw system that is intended for fixation of sacroiliac joint disruptions in skeletally mature patients. This has been, and continues to be, a product differentiator, as many competitors do not offer SI fixation options.
Sacroiliac ("SI") Joint Fusion Procedures Firebird SI is a 3D printed, minimally invasive screw system that is intended for fixation of sacroiliac joint disruptions in skeletally mature patients. This has been, and continues to be, a product differentiator, as many competitors do not offer SI fixation options.
Competition The global spine, biologics, orthopedics, and image guided surgery markets are highly competitive. We face significant competition in these markets from the spine and orthopedic divisions of large multinational medical device companies, established companies focused solely or primarily on spine and orthopedics, and from smaller, emerging companies focused on product innovation.
Competition The global spine, biologics, limb reconstruction, and image guided surgery markets are highly competitive. We face significant competition in these markets from the spine and orthopedic divisions of large multinational medical device companies, established companies focused solely or primarily on spine and orthopedics, and from smaller, emerging companies focused on product innovation.
Our primary competitors in the Biologics, Enabling Technologies, and Spinal Implants markets include Alphatec Spine, Baxter, B. Braun, Brainlab, Bioventus, Cerapedics, DePuy Synthes Spine (a Johnson & Johnson company), Globus Medical, Highridge Medical, Medtronic, Stryker, XTANT Medical, and various smaller public and private companies.
Our primary competitors in the Biologics, Enabling Technologies, and Spinal Implants markets include Alphatec Spine, Baxter, B. Braun, Brainlab, Bioventus, Cerapedics, DePuy Synthes Spine (a Johnson & Johnson company), Globus Medical, Highridge Medical, Medtronic, VB Spine, XTANT Medical, and various smaller public and private companies.
The terms of our license and assignment agreements vary in length from a specified number of years, to the life of the patents, or for the economic life of the product. These agreements generally provide for royalty payments and termination rights in the event of a material breach.
The terms of our license and assignment agreements vary in length from a specified number of years, to the life of the patent, or for the economic life of the product. These agreements generally provide for royalty payments and termination rights in the event of a material breach.
("ACHC"), for medical supply provider services with respect to durable medical equipment, prosthetics, orthotics, and supplies ("DMEPOS"). ACHC, a private, not-for-profit corporation, which is certified to ISO 9001:2015 standards, was developed by home care and community-based providers to help companies improve business operations and quality of patient care.
("ACHC"), for medical supply provider services with respect to durable medical equipment, prosthetics, orthotics, and supplies ("DMEPOS"). ACHC, a private, not-for-profit corporation, which is certified to International Organization of Standardization ("ISO") 9001:2015 standards, was developed by home care and community-based providers to help companies improve business operations and quality of patient care.
In the U.S., we typically consign our Biologics products and consign or loan our Spinal Implants and Orthopedics implant sets to hospitals and independent sales agents, who in turn deliver them to the hospital for a single surgical procedure. In other instances, we leave sets with hospitals that are high volume users for use in multiple procedures.
In the U.S., we typically consign our Biologics products and consign or loan our Spinal Implants and Limb Reconstruction implant sets to hospitals and independent sales agents who in turn deliver them to the hospital for a single surgical procedure. In other instances, we leave sets with hospitals that are high volume users for use in multiple procedures.
These competitors are focused on bringing new technologies to market and acquiring technologies and technology licenses that directly compete with our products or that have potential product advantages that could render our products obsolete or noncompetitive. Our Bone Growth Therapies product category competes principally with similar products marketed by Highridge Medical, Enovis, Bioventus, Theragen, and Xstim.
These competitors are focused on bringing new technologies to market and acquiring technologies and technology licenses that directly compete with our products or that have potential product advantages that could render our products obsolete or noncompetitive. Our Bone Growth Therapies product category competes principally with similar products marketed by EBI, Enovis, Bioventus, Theragen, and Xstim.
The SpinalStim device is a non-invasive spinal fusion stimulator system designed for the treatment of the lumbar region of the spine. The device uses proprietary technology and a wavelength to generate a PEMF signal.
The SpinalStim device is a non-invasive spinal fusion stimulator system designed for the treatment of the lumbar region of the spine. The device uses proprietary technology and a wavelength to generate a PEMF signal. The U.S.
Devices deemed to pose low risk are placed in Class I, devices deemed to pose moderate risk are placed in Class II, and devices deemed to pose the greatest risks, requiring more regulatory controls to provide a reasonable assurance of safety and effectiveness, or devices deemed not substantially equivalent to a device that previously received 510(k) clearance (as described below), are placed in Class III.
Devices deemed to pose low risk are placed in Class I, devices deemed to pose moderate risk are placed in Class II, and devices deemed to pose the greatest risks, requiring more regulatory controls to provide a reasonable assurance of safety and effectiveness, or devices deemed not substantially equivalent to a device that previously received 510(k) clearance, are placed in Class III.
We have exclusive worldwide rights to market the Virtuous and Trinity Elite, and exclusive rights to market the FiberFuse tissues in the U.S. Our other leading tissue forms and synthetics such as, Strand Plus, Strand, Evo3, Evo3c, Ballast, Cove, and Mozaik are all processed internally through IsoTis Orthobiologics.
We have exclusive worldwide rights to market Virtuos and Trinity Elite, and exclusive rights to market the FiberFuse tissues in the U.S. Our other leading tissue forms and synthetics, such as Strand Plus, Strand, Evo3, Evo3c, Ballast, Cove, and Mozaik are all processed internally through IsoTis Orthobiologics, Inc.
We receive marketing fees through our collaboration with MTF Biologics for Virtuous, Trinity Elite, FiberFuse, and certain other tissues. MTF Biologics processes the tissues, maintains inventory, and invoices hospitals, surgery centers, and other points of care for service fees, which are submitted by customers via purchase orders.
We receive marketing fees through our collaboration with MTF for Virtuos, Trinity Elite, FiberFuse, and certain other tissues. MTF processes the tissues, maintains inventory, and invoices hospitals, surgery centers, and other points of care for service fees, which are submitted by customers via purchase orders.
Our Bone Growth Therapies product category is largely supported by a hybrid distribution network of direct sales representatives and independent distributors, whereas our Spinal Implants, Biologics, and Orthopedics sales organizations primarily consist of regional and territory business managers who oversee a broad network of independent distributors and sales agents.
Our Bone Growth Therapies product category is largely supported by a hybrid distribution network of direct sales representatives and independent distributors, whereas our Spinal Implants, Biologics, and Limb Reconstruction sales organizations primarily consist of regional and territory business managers who oversee a broad network of independent distributors and sales agents.
Our team refines or redesigns the prototype as necessary based on the results of the product testing, allowing our team to perform rapid iterations of the design-prototype-test development cycle. Our clinical and regulatory personnel work in parallel with our product engineering personnel to facilitate regulatory clearances of our products.
Our development teams refines or redesigns the prototype as necessary based on the results of the product testing, allowing us to perform rapid iterations of the design-prototype-test development cycle. Our clinical and regulatory personnel work in parallel with our product engineering personnel to facilitate regulatory clearances of our products.
The shares of common stock of Orthofix, as the corporate parent entity in the combined company structure, continue following the Merger to trade on NASDAQ under the symbol "OFIX".
Following the Merger, the shares of common stock of Orthofix, as the corporate parent entity in the combined company structure, continued to trade on NASDAQ under the symbol "OFIX".
This includes the design of specific software modules, features, and tracked instruments designed to meet the needs of a wide range of procedures including, degenerative, complex, revision, minimally invasive and deformity spine procedures. In addition, we are also exploring opportunities to integrate the 7D FLASH Technology into a variety of orthopedic applications to treat patients of all ages.
This includes the design of specific software modules, features, and tracked instruments designed to meet the needs of a wide range of procedures including degenerative, complex, revision, minimally invasive, and spinal deformity cases. In addition, we are also exploring opportunities to integrate the 7D FLASH Navigation technology into a variety of orthopedic applications to treat patients of all ages.
Although we take steps designed to provide that our products are safe and free of agents that can cause disease, products that contain materials derived from animals, including our products, may become subject to additional regulation, or even be banned in certain countries, because of concern over the potential for prion transmission.
Although we take steps designed to ensure that our products are safe and free of agents that can cause disease, products that contain materials derived from animals, including our products, may become subject to additional regulation, or even be banned in certain countries, because of concerns over the potential for prion transmission.
We believe that these product development efforts allow our team to provide solutions that respond to the needs of our surgeon customers and their patients.
We believe that these product development efforts allow us to provide solutions that respond to the needs of our surgeon customers and their patients.
These biologic, device, or drug HCT/Ps must comply both with the requirements exclusively applicable to HCT/Ps and with requirements applicable to biologics, devices, or drugs, including premarket clearance or approval from the FDA. Section 361 of the Public Health Service Act authorizes the FDA to issue regulations to prevent the introduction, transmission, or spread of communicable disease.
These biologic, device, or drug HCT/Ps must comply both with the requirements exclusively applicable to HCT/Ps and with requirements applicable to biologics, devices, or drugs, including 510(k) clearance or PMA approval from the FDA. Section 361 of the Public Health Service Act authorizes the FDA to issue regulations to prevent the introduction, transmission, or spread of communicable disease.
Our Spinal Implants and Global Orthopedics products are, for the most part, classified as Class II devices and the instruments used with these products are generally classified as Class I. Our 7D FLASH Navigation System is classified as Class II and certain accessories thereto are classified as Class I.
Our Spinal Implants and Global Limb Reconstruction products are, for the most part, classified as Class II devices and the instruments used with these products are generally classified as Class I. Our 7D FLASH Navigation System is classified as Class II and certain accessories thereto are classified as Class I.
Our relations with our Italian employees, who numbered 229 at December 31, 2024, are governed by the provisions of a National Collective Labor Agreement setting forth mandatory minimum standards for labor relations in the metal mechanic workers industry. We are not a party to any other collective bargaining agreements.
Our relations with our Italian employees, who numbered 247 at December 31, 2025, are governed by the provisions of a National Collective Labor Agreement setting forth mandatory minimum standards for labor relations in the metal mechanic workers industry. We are not a party to any other collective bargaining agreements.
Traditional spine navigation requires a preoperative CT or intraoperative radiation for image acquisition and registration. 7D MRVision is the 13 first and only solution that eliminates radiation from the entire navigation workflow. Further enhancements and new features to the Spine Module and Percutaneous Module are in development and are expected to launch in 2025.
Traditional spine navigation requires a preoperative CT scan or intraoperative radiation for image acquisition and registration. 7D MRVision is the first and only solution that eliminates radiation from the entire navigation workflow. Further enhancements and new features to the Spine Module and Percutaneous Module are in development and are expected to launch in 2026.
These sets typically contain the instruments, including disposables, and implants required to complete a surgery. Our Orthopedics business provides a wide array of single use pack procedural solutions, alleviating the burden of instrument sets.
These sets typically contain the instruments, including disposables, and implants required to complete a surgery. Our Limb Reconstruction business provides a wide array of single use pack procedural solutions, alleviating the burden of instrument sets.
Our cellular allografts portfolio features a market-leading graft with Trinity Elite and recently released Virtuous Lyograft, both co-branded with MTF Biologics. Trinity Elite, an allograft with viable cells, has maintained position as a market leader with over a decade of clinical evidence and a series of peer-reviewed publications.
Our cellular allografts portfolio features a market-leading graft with Trinity Elite, and the recently released Virtuos Lyograft, both co-branded with MTF. Trinity Elite, an allograft with viable cells, has maintained position as a market leader with over a decade of clinical evidence and a series of peer-reviewed publications.
This completely integrated business unit allows for a continuous feedback cycle with research and development, marketing, manufacturing, and quality to ensure high-quality products delivered with consistent customer fulfillment. To date, our Biologics products are offered primarily in the U.S. market, due in part to restrictions on providing U.S. human donor tissue and bovine collagen in certain countries.
This completely integrated business unit allows for a continuous feedback cycle among our research and development, marketing, manufacturing, and quality management units to ensure high-quality products and consistent customer fulfillment. To date, our Biologics products are offered primarily in the U.S. market, due in part to restrictions on providing U.S. human donor tissue and bovine collagen in certain countries.
Bone Growth Therapies, Spinal Implants, Enabling Technologies, and Global Orthopedic Products We generally design, develop, assemble, test, and package our Bone Growth Therapies, Spinal Implants, Enabling Technologies, and Global Orthopedic products, and subcontract the manufacturing of a substantial portion of the component parts and instruments.
Bone Growth Therapies, Spinal Implants, Enabling Technologies, and Global Limb Reconstruction Products We generally design, develop, assemble, test, and package our Bone Growth Therapies, Spinal Implants, Enabling Technologies, and Global Limb Reconstruction products, and subcontract the manufacturing of a substantial portion of the component parts and instruments.
Fitbone Intramedullary Limb-Lengthening System An intramedullary lengthening system intended for limb lengthening of the femur and tibia, surgically implanted in the bone through a minimally invasive procedure; it includes an external telemetry control set that manages the distraction process, and is the only intramedullary limb lengthening system with an FDA-cleared pediatric indication.
Fitbone Intramedullary Limb-Lengthening System An intramedullary lengthening system intended for limb lengthening of the femur and tibia, surgically implanted in the bone through an MIS procedure; it includes an external telemetry control set that manages the distraction process, and is the only intramedullary limb lengthening system with an FDA-cleared pediatric indication.
OrthoNext Digital Platform A digital software platform developed specifically to enable surgeons to perform deformity analysis, plan out the correction, and template the appropriate implant to use. The platform includes modules for the JuniOrtho Plating System, Fitbone Intramedullary Limb Lengthening System, and more recently added TL-Hex system.
OrthoNext Digital Platform A digital software platform developed specifically to enable surgeons to perform deformity analysis, prepare a correction procedure plan, and template the appropriate implant to use. The platform includes modules for the JuniOrtho Plating System, Fitbone Intramedullary Limb Lengthening System, and more recently, the TL-HEX system.
Growth initiatives include: • A regular cadence of new and differentiated product launches supporting our spine implant and enabling technologies, biologics, and bone growth therapies portfolios; • Ongoing, global sales channel optimization and expansion; • Reinforcement of our bone growth stimulation business through the collection and dissemination of clinical evidence, and the delivery of new and novel value-added services; • Conducting clinical research to support and broaden our spine implant, biologics, and bone growth stimulation portfolios; • Acquiring or licensing products, technologies, and companies to further expand and enhance our spine portfolio; • Investing in the further development of our pre-clinical and clinical programs designed to generate peer-reviewed scientific evidence in support of our products; and • Attracting, developing, and retaining key talent.
Growth initiatives include: • a regular cadence of new and differentiated product launches supporting our spinal implants and enabling technologies, biologics, and bone growth therapies portfolios; • ongoing, global sales channel optimization and expansion; • reinforcement of our bone growth stimulation business through the collection and dissemination of clinical evidence, and the delivery of new and novel value-added services; • conducting clinical research to support and broaden our spinal implants, biologics, and bone growth stimulation portfolios; • acquiring or licensing products and technologies, and acquiring or collaborating with other entities to further expand and enhance our spine portfolio; • investing in the further development of our pre-clinical and clinical programs designed to generate peer-reviewed scientific evidence in support of our products; and • attracting, developing, and retaining key talent.
Similar to our SpinalStim and CervicalStim systems, the PhysioStim device is also accompanied by the STIM onTrack mobile app, enabling physicians treating patients with nonunion fractures to remotely view and assess patient adherence to prescribed treatment protocols and patient reported outcome measures.
Similar to our SpinalStim and CervicalStim systems, the PhysioStim devices are also accompanied by the STIM onTrack mobile app, enabling physicians treating patients with nonunion fractures to remotely view and assess patient adherence to prescribed treatment protocols and patient reported outcome measures.
Synthetics Cove, Mozaik To address the synthetic market segment, this portfolio includes an advanced bioactive synthetic and a value-based offering to meet different customer profiles. Provided in both putty and strip formulations. Procedure specific solutions Market-differentiated products focused on solving clinical problems tied to specific procedure techniques in spine for fusion.
Synthetics Cove, Mozaik To address the synthetic market segment, this portfolio includes an advanced bioactive synthetic and a value-based offering to meet different customer profiles. Available in both putty and strip formulations. Procedure specific solutions Market-differentiated products focused on solving clinical problems tied to specific spinal fusion procedure techniques.
Our Bone Growth Therapies products and the M6-C artificial cervical disc are currently classified as Class III, and have been approved for commercial distribution in the U.S. through the PMA process. However, an FDA panel recommended that bone growth stimulator devices be reclassified by the FDA from Class III to Class II devices with special controls.
Our Bone Growth Therapies products are currently classified as Class III, and have been approved for commercial distribution in the U.S. through the PMA process. However, an FDA panel recommended that bone growth stimulator devices be reclassified by the FDA from Class III to Class II devices with special controls.
Cellular Bone Matrixes ("CBM") Trinity Elite, Virtuos Lyograft Comprised of demineralized cortical bone fibers and cancellous bone with retained cells, cellular allografts are used during surgery that is designed to aid in the success of a spinal fusion or bone fusion procedure. Provided in either a cryopreserved or shelf-stable form.
Cellular Bone Matrixes Trinity Elite, Virtuos Lyograft Comprised of demineralized cortical bone fibers and cancellous bone with retained cells, these types of cellular allografts are used during surgery that is designed to aid in the success of a spinal fusion or bone fusion procedure. Available in either a cryopreserved or shelf-stable form.
We market our Enabling Technologies portfolio through a direct sales force in the U.S. who collaborate with our independent sales agents to generate either a capital sale or to place systems and components in an account in a capital efficient manner in return for a long-term revenue commitment for our Spinal Implants and/or Biologics products.
We market our Enabling Technologies portfolio through a direct sales force in the U.S. who collaborate with our independent sales agents to generate either a capital sale or place systems and components with a hospital in return for a long-term revenue commitment for our Spinal Implants and/or Biologics products.
Several of our solutions address this through handling characteristics of product, shape and design, instrumentation to aid delivery, or even added materials to aid in graft containment. All of these solutions are to improve the ease of use and consistency of our products while driving better clinical outcomes.
Several of our solutions address these issues through product handling characteristics, shape and design, instrumentation to aid delivery, or even added materials to aid in graft containment. All of these features aim to improve the ease of use and consistency of our products while driving better clinical outcomes.
These sets are constructed with an industry-leading number of connectors, specially designed rods, and instruments to aid in these cases. Giving surgeons a tremendous number of options is the key to the success of these sets.
These sets are constructed with an industry-leading number of connectors, specially designed rods, and instruments to aid in these cases. Giving surgeons an extensive range of options is the key to the success of these sets.
Our products are distributed in more than 60 countries worldwide. 22 Reporting Segments and Product Categories We manage our business by two reporting segments, Global Spine and Global Orthopedics, which account for 84% and 16%, respectively, of our total net sales in 2024.
Our products are distributed in more than 60 countries worldwide. 22 Reporting Segments and Product Categories We manage our business by two reporting segments, Global Spine and Global Limb Reconstruction, which account for 84% and 16%, respectively, of our total net sales in 2025.
Interbody Our robust interbody group has options for every approach vector, including anterior lumbar, posterior lumbar, and lateral. Within each group there are several material types, including a thermoplastic compound called PEEK, 3D printed titanium with FDA approved Nanotechnology claims, and two different composites, Nanometalene and PTC, comprised of both PEEK and titanium.
Interbody Our robust interbody group has options for every approach vector, including anterior lumbar, posterior lumbar, and lateral. Within each group there are several material types, including a thermoplastic compound called PEEK, 3D Printed Ti, and two different composites, NanoMetalene and PTC, each comprised of both PEEK and titanium.
For our spine and orthopedics products, our product development teams, in consultation with design surgeons, formulate a design for the product and then our machinists build prototypes for testing our prototyping development and testing operation at our 17 facilities. We use a broad scope of technologies designed to allow us to meet the complex engineering requirements of customers.
For our spine and limb reconstruction products, our product development teams, in consultation with design surgeons, formulate a design for the product and then our machinists build prototypes for testing our prototyping development and testing operation at our facilities. We use a broad range of technologies designed to allow us to meet the complex engineering requirements of customers.
For Global Orthopedics devices, our principal competitors include DePuy Synthes, Stryker, Smith & Nephew, Globus Medical, Enovis, Paragon 28, and OrthoPediatrics.
For Global Limb Reconstruction devices, our principal competitors include DePuy Synthes, Stryker, Smith & Nephew, Globus Medical, Enovis, Paragon 28, and OrthoPediatrics.
The FDA has approved the SpinalStim system as a spinal fusion adjunct to increase the probability of fusion success and as a non-operative treatment for salvage of failed spinal fusion at least nine months post-operatively. Our CervicalStim product remains the only FDA-approved bone growth stimulator on the market indicated for use as an adjunct to cervical spine fusion surgery.
Food and Drug Administration ("FDA") has approved the SpinalStim device as a spinal fusion adjunct to increase the probability of fusion success and as a non-operative treatment for salvage of failed spinal fusion at least nine months post-operatively. 11 Our CervicalStim device remains the only FDA-approved bone growth stimulator on the market indicated for use as an adjunct to cervical spine fusion surgery.
The novel technology allows for a fast image reconstruction for surgical navigation with no disruption to surgeon workflow and eliminates radiation exposure during the procedure to the patient, surgeon, and operating room staff. Our Spine Module is our leading product in the FLASH Navigation Portfolio.
This novel technology allows for a fast image reconstruction for surgical navigation with no disruption to surgeon workflow and eliminates radiation exposure during the procedure to the patient, surgeon, and operating room staff. Our Spine Module, geared towards open spine procedures, is our leading product in the 7D FLASH Navigation portfolio.
Patents, Trade Secrets, Assignments and Licenses We rely on a combination of patents, trade secrets, assignment and license agreements, and non-disclosure agreements to protect our proprietary intellectual property. We possess numerous U.S. and foreign patents, have numerous pending patent applications, and have license rights under patents held by third parties.
Patents, Trade Secrets, Assignments and Licenses We rely on a combination of patents, trademarks, trade secrets, assignments, licenses, and confidentiality agreements to protect our intellectual property. We possess numerous U.S. and foreign patents, have numerous pending patent applications, and have license rights under patents held by third parties.
Like the spine and orthopedics product development process, our software engineers, product managers, and design surgeons are working towards the full integration of our spinal implants and biologics product lines with our machine vision 7D FLASH Navigation System.
Like the spine and limb reconstruction product development process, our software engineers, product managers, and design surgeons are working towards the full integration of our spinal implants and biologics product lines with our 7D FLASH Navigation System.
Human Capital Resources Our key human capital objectives in managing our business include attracting, developing, and retaining top talent while integrating diversity, equity, and inclusion principles into our core values. Employees As of December 31, 2024, we had 1,616 employees worldwide. Of these, 1,256 were employed in the U.S. and 360 were employed at other non-U.S. locations.
Human Capital Resources Our key human capital objectives in managing our business include attracting, developing, and retaining top talent while integrating diversity, equity, and inclusion principles into our core values. Employees As of December 31, 2025, we had 1,605 employees worldwide. Of these, 1,222 were employed in the U.S. and 383 were employed at other non-U.S. locations.
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.
By providing medical technologies that heal musculoskeletal pathologies, Orthofix delivers exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, limb reconstruction solutions, biologics and enabling technologies, including the 7D FLASH Navigation System.
In 2024, we further enhanced the 7D FLASH Navigation System with the release of our 7D MRVision utilizing MRIguidance’s BoneMRI software to generate a synthetic CT from an MRI scan that can be used for surgical planning and spinal navigation with the 7D FLASH Navigation System Spine Module.
In 2025, we further commercialized the 7D FLASH Navigation System with the release of our 7D MRVision. Utilizing MRIguidance’s BoneMRI software to generate a synthetic computed tomography ("CT") from an MRI scan, 7D MRVision can be used with the 7D FLASH Navigation System Spine Module for surgical planning and spinal navigation.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeDollar) other than their functional currency. 2024 Compared to 2023 Interest expense, net, increased $21.0 million • Unfavorable change of $13.3 million attributable to an increase in outstanding indebtedness compared to prior year • Unfavorable change of $6.9 million attributable to the extinguishment of the Financing Agreement with Blue Torch Finance LLC • Unfavorable change of $0.8 million as a result of the conversion of the convertible loan with Neo Medical into preferred equity securities in the second quarter of 2024 and subsequent sale of such securities in the fourth quarter of 2024 Other expense, net, increased $8.7 million • Unfavorable change of $6.0 million associated with changes in foreign currency exchange rates, as we recorded a non-cash remeasurement loss of ($4.4 million) in 2024 compared to a gain of $1.6 million in 2023 • Unfavorable change of $2.5 million associated with gains and losses recognized on certain investments measured at fair value Income Tax Expense Percentage Change (U.S.
Biggest changeDollar) other than their functional currency. 2025 Compared to 2024 Interest expense, net, decreased $12.1 million • Favorable change of $11.4 million associated with the extinguishment of our former Financing Agreement with Blue Torch Finance LLC and from favorable interest rates and amortization of debt issuance costs after refinancing our outstanding indebtedness in November 2024 • Favorable change of $0.9 million resulting from interest earned on certain Employee Retention Credit refunds received during 2025 • Partially offset by an unfavorable change of $0.2 million as a result of the conversion of our former convertible loan with Neo Medical into preferred equity securities in the second quarter of 2024 Other income (expense), net, increased $17.7 million • Favorable change of $7.3 million associated with foreign currency exchange rates, as we recorded a non-cash remeasurement gain of $2.9 million in 2025 compared to a loss of $4.4 million in 2024 • Favorable change of $5.1 million, related to impairments totaling $6.8 million on certain investments measured at fair value in prior year and partially offset by a $1.7 million gain recognized in the prior year upon conversion of the Neo Medical convertible loan into shares of equity 59 • Favorable change of $4.8 million from the receipt of Employee Retention Credit refunds received during 2025 Income Tax Expense Percentage Change (U.S.
In particular, certain of our DBM products are priced at a premium to competitors' DBM products and a significant price reduction could result in a material adverse effect on our profitability. • Physicians increasingly have moved from independent, out-patient practice settings toward employment by hospitals and other larger healthcare organizations, which align physicians’ product choices with their employers’ price sensitivities and adds to pricing pressures.
In particular, certain of our DBM products are priced at a premium to competitors' DBM products and a significant price reduction could result in a material adverse effect on our profitability. • Physicians have increasingly moved from independent, out-patient practice settings toward employment by hospitals and other larger healthcare organizations, which align physicians’ product choices with their employers’ price sensitivities and adds to pricing pressures.
The Initial Term Loan and Delayed Draw Term Loans, to the extent ultimately drawn, will each mature in November 2029, following an interest-only payment period ending December 2028, and monthly amortization of principal and accrued interest between January 2029 and November 2029.
The Initial Term Loan and Delayed Draw Term Loans, to the extent ultimately drawn, will each mature in November 2029, following an interest-only payment period ending December 2028, and monthly amortization of principal and accrued interest between January 2029 and November 2029.
Healthcare fraud and abuse laws potentially applicable to our operations include: • The federal Anti-Kickback Statute, which prohibits knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in exchange for or to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program (such as the Medicare or Medicaid programs); • The federal Stark law, which prohibits physician self-referral, specifically a referral by a physician of a Medicare or Medicaid patient to an entity providing designated health services if the physician or an immediate family member has a financial relationship with that entity; • Federal false claims laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other federal government payors that are false or fraudulent; and • State and non-U.S. laws analogous to each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by non-governmental or non-U.S. governmental third-party payors, including commercial insurers.
Healthcare fraud and abuse laws potentially applicable to our operations include: • The federal Anti-Kickback Statute, which prohibits knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in exchange for or to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program (such as the Medicare or Medicaid programs); • The federal Stark law, which prohibits physician self-referral, specifically a referral by a physician of a Medicare or Medicaid patient to an entity providing designated health services if the physician or an immediate family member has a financial relationship with that entity; • Federal false claims laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other federal government payors that are false or fraudulent; and 39 • State and non-U.S. laws analogous to each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by non-governmental or non-U.S. governmental third-party payors, including commercial insurers.
Market acceptance of any of our products requires, among other things, that we timely secure regulatory clearance and/or approval; demonstrate the value of our products, both to our physician customers and payors, which may require that we collect clinical data and/or conduct clinical studies; effectively educate and train our physician customers and their staff on the proper use of our products; obtain and maintain coverage and adequate reimbursement for our products, both within and outside the U.S., including under Medicare and 34 Medicaid and from private payors; attract and retain a network of independent sales agents and stocking distributors focused on neurophysicians and orthopedic spine physicians; develop and execute effective marketing strategies; protect the proprietary positions of our products, including through patent protection; and consistently produce quality products in sufficient quantities to meet demand.
Market acceptance of any of our products requires, among other things, that we timely secure regulatory clearance and/or approval; demonstrate the value of our products, both to our physician customers and payors, which may require that we collect clinical data and/or conduct clinical studies; effectively educate and train our physician customers and their staff on the proper use of our products; obtain and maintain coverage and adequate reimbursement for our products, both within and outside the U.S., including under Medicare and Medicaid and from private payors; attract and retain a network of independent sales agents and stocking distributors focused on neurophysicians and orthopedic spine physicians; develop and execute effective marketing strategies; protect the proprietary positions of our products, including through patent protection; and consistently produce quality products in sufficient quantities to meet demand.
The Credit Agreement contains customary affirmative and negative covenants, including limitations on our and our subsidiaries’ ability to incur additional debt, grant or permit additional liens, make certain investments and acquisitions, merge or consolidate with others, dispose of certain assets, pay dividends and distributions, pay subordinated indebtedness, and enter into affiliate transactions, as well as financial covenants that we (i) maintain $15.0 million of unrestricted cash in U.S.-based accounts, and (ii) maintain a maximum total debt-to-EBITDA leverage ratio no greater than 4.0x during the term of the facility.
The Credit Agreement contains customary affirmative and negative covenants, including limitations on our and our subsidiaries’ ability to incur additional debt, grant or permit additional liens, make certain investments and acquisitions, merge or consolidate with others, dispose of certain assets, pay dividends and distributions, pay subordinated indebtedness, and enter into affiliate 49 transactions, as well as financial covenants that we (i) maintain $15.0 million of unrestricted cash in U.S.-based accounts, and (ii) maintain a maximum total debt-to-EBITDA leverage ratio no greater than 4.0x during the term of the facility.
The success of any of our new product offerings or enhancement or modification to our existing products will depend on several factors, including our ability to: • properly identify and anticipate physician and patient needs; • develop new products, enhancements, or modifications in a timely manner; • obtain regulatory clearance and/or approvals for new products or product enhancements or modifications in a timely manner; • achieve timely alpha and/or full commercial launches of new products; • provide adequate training to potential users of new products and product enhancements or modifications; • receive adequate reimbursement approval of third-party payors such as Medicaid, Medicare, and private insurers; • gain broad market acceptance (including by physicians); and • develop an effective marketing and distribution network.
The success of any of our new product offerings or enhancement or modification to our existing products will depend on several factors, including our ability to: • properly identify and anticipate physician and patient needs; • develop new products, enhancements, or modifications in a timely manner; • obtain regulatory clearance and/or approvals for new products or product enhancements or modifications in a timely manner; • achieve timely alpha and/or full commercial launches of new products; • provide adequate training to potential users of new products and product enhancements or modifications; • receive adequate reimbursement approval of third-party payors such as Medicaid, Medicare, and private insurers; 30 • gain broad market acceptance (including by physicians); and • develop an effective marketing and distribution network.
There can be no assurance that the FDA will not at some future date re-classify the allograft tissues, and the reclassification of this product from a human tissue to a medical device could have adverse consequences for us or 35 for the supplier of this product and make it more difficult or expensive for us to conduct this business by requiring premarket clearance or approval, as well as compliance with additional post-market regulatory requirements.
There can be no assurance that the FDA will not at some future date re-classify the allograft tissues, and the reclassification of this product from a human tissue to a medical device could have adverse consequences for us or for the supplier of this product and make it more difficult or expensive for us to conduct this business by requiring premarket clearance or approval, as well as compliance with additional post-market regulatory requirements.
Executive Summary Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, 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.
Executive Summary 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.
U.S. government agencies continue efforts to modify regulations promulgated under the ACA. For example, CMS began permitting states to impose work requirements on persons covered by Medicaid expansion plans, certain federal subsidies to insurers have ended, and certain short-term insurance plans not offering the full array of ACA benefits have been allowed to extend in duration.
U.S. government agencies continue efforts to modify regulations promulgated under the ACA. For example, CMS began permitting states to impose work requirements on persons covered by Medicaid expansion plans, certain federal subsidies have ended, and certain short-term insurance plans not offering the full array of ACA benefits have been allowed to extend in duration.
In addition, we have been and may in the future be subject to litigation and claims that we caused an employee, or encouraged/assisted an 46 independent sales agent, to breach the terms of his or her non-competition or non-solicitation agreement. Defending and litigating these claims is expensive and time-consuming, and could divert management attention and resources away from our business.
In addition, we have been and may in the future be subject to litigation and claims that we caused an employee, or encouraged/assisted an independent sales agent, to breach the terms of his or her non-competition or non-solicitation agreement. Defending and litigating these claims is expensive and time-consuming, and could divert management attention and resources away from our business.
If we fail to maintain an effective system of internal controls or if management or our independent registered public accounting firm were to discover material weaknesses in 27 our internal controls, we may be unable to produce reliable financial reports or prevent fraud, which could harm our financial condition and operating results, and could result in a loss of investor confidence and a decline in our stock price.
If we fail to maintain an effective system of internal controls or if management or our independent registered public accounting firm were to discover material weaknesses in our internal controls, we may be unable to produce reliable financial reports or prevent fraud, which could harm our financial condition and operating results, and could result in a loss of investor confidence and a decline in our stock price.
The European Commission ("EC") has harmonized national regulations for the control of medical devices through European Medical Device Directives ("MDD") with which manufacturers must comply. Under these new regulations, manufacturing plants must have received a full Quality Assurance Certification from a "Notified Body" in order to be able to sell products within the member states of the E.U.
The EC has harmonized national regulations for the control of medical devices through European Medical Device Directives ("MDD") with which manufacturers must comply. Under these new regulations, manufacturing plants must have received a full Quality Assurance Certification from a "Notified Body" in order to be able to sell products within the member states of the E.U.
Raw materials had not been subjected to any manufacturing processes that would add additional value, therefore we determined book value is representative of fair value. We assessed the fair value of the WIP and finished goods inventory using the comparative sales method. The estimated step-up in fair value on acquired inventory recognized in connection with the Merger was $48.2 million.
Raw materials had not been subjected to any manufacturing processes that would add additional value, therefore we determined book value was representative of fair value. We assessed the fair value of the WIP and finished goods inventory using the comparative sales method. The estimated step-up in fair value on acquired inventory recognized in connection with the Merger was $48.2 million.
On an ongoing basis, we evaluate these estimates, which are based on historical experience and various other assumptions that management believe to be reasonable under the circumstances at that point in time. Actual results may differ, significantly at times, from these estimates. We believe the estimates described below are the most critical in preparing our consolidated financial statements.
On an ongoing basis, we evaluate these estimates, which are based on historical experience and various other assumptions that management believes to be reasonable under the circumstances at that point in time. Actual results may differ, significantly at times, from these estimates. We believe the estimates described below are the most critical in preparing our consolidated financial statements.
If conditions or assumptions used in determining the market value or forecasted demand change, additional inventory adjustments in the future may be necessary. Our inventory allowance is a "critical accounting estimate" because changes in the assumptions used to develop the estimate could materially affect key financial measures, including gross profit, operating income, adjusted EBITDA, net income, and inventory.
If conditions or assumptions used in determining the market value or forecasted demand change, additional inventory adjustments in the future may be necessary. Our inventory allowance is a "critical accounting estimate" because changes in the assumptions used to develop the estimate could materially affect key financial measures, including gross profit, operating income, adjusted EBITDA, net income, and inventories.
In addition, the ACA, as well as certain state laws, require detailed disclosure of expenses incurred on behalf of and remuneration made to certain healthcare 29 professionals and teaching hospitals, the publicity surrounding which could have a negative impact on our relationships with our customers and ability to seek input on product design or involvement in research.
In addition, the ACA, as well as certain state laws, require detailed disclosure of expenses incurred on behalf of and remuneration made to certain healthcare professionals and teaching hospitals, the publicity surrounding which could have a negative impact on our relationships with our customers and ability to seek input on product design or involvement in research.
These processes endeavor to follow the National Institute of Standards and Technology ("NIST") Cybersecurity Framework and are tested at least annually. Our Information Security team uses automated technology, third-party partners, and direct review of system indicators to monitor and implement the prevention, detection, mitigation, and remediation of cybersecurity incidents, and to stay current with the changing threat landscape.
These processes endeavor to follow the National Institute of Standards and Technology Cybersecurity Framework and are tested at least annually. Our Information Security team uses automated technology, third-party partners, and direct review of system indicators to monitor and implement the prevention, detection, mitigation, and remediation of cybersecurity incidents, and to stay current with the changing threat landscape.
The Company’s investment in foreign subsidiaries continues to be indefinite in nature; however, the Company may periodically repatriate a portion of these earnings to the extent that it does not incur significant additional tax liability. Contractual Obligations As a result of our operations, we are subject to certain contractual obligations with material cash requirements.
Unremitted Foreign Earnings The Company’s investment in foreign subsidiaries continues to be indefinite in nature; however, the Company may periodically repatriate a portion of these earnings to the extent that it does not incur significant additional tax liability. Contractual Obligations As a result of our operations, we are subject to certain contractual obligations with material cash requirements.
We measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. We re-evaluate our income tax positions periodically to consider factors such as changes in facts or circumstances, changes in or interpretations of tax law, effectively settled issues under audit, and new audit activity.
We measure the tax benefit as the 66 largest amount that is more than 50% likely to be realized upon ultimate settlement. We re-evaluate our income tax positions periodically to consider factors such as changes in facts or circumstances, changes in or interpretations of tax law, effectively settled issues under audit, and new audit activity.
In addition, various regulators around the world currently require, or may in the future require, increased reporting of company ESG metrics, which will raise our costs of ESG compliance. Our business could be negatively impacted by such requirements. Any such requirements or matters, or related corporate citizenship and sustainability matters, could have a material adverse effect on our business.
In addition, various regulators around the world currently require, or may in the future require, increased reporting of company ESG metrics, which may raise our costs of ESG compliance. Our business could be negatively impacted by such requirements. Any such requirements or matters, or related corporate citizenship and sustainability matters, could have a material adverse effect on our business.
Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures. 68 The non-GAAP financial measures used in this Annual Report may have limitations as analytical tools and should not be considered in isolation or as a replacement for GAAP financial measures.
Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures. The non-GAAP financial measures used in this Annual Report may have limitations as analytical tools and should not be considered in isolation or as a replacement for GAAP financial measures.
We evaluate the tax position taken or expected to be taken in a tax return by determining if the 67 weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes.
We evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes.
The enactment of or increases in tariffs, or other such charges, on specific products that we sell or with which our products compete, may have an adverse effect on our business or on our results of operations. The sales and marketing practices of our industry have been the subject of increased scrutiny from federal and state government agencies.
The enactment of or increases in tariffs, or other such charges, on specific products that we sell or with which our products compete, may have an adverse effect on our business or on our results of operations. 40 The sales and marketing practices of our industry have been the subject of increased scrutiny from federal and state government agencies.
Our effective income tax rate could be adversely affected by changes in those tax laws, changes in the mix of earnings among tax jurisdictions, changes in the valuation of our deferred tax assets and liabilities, vesting of equity awards at a price below the original valuation, historical entity classification elections, and the resolution of matters arising from tax audits.
Our effective income tax rate could be adversely affected by changes in those tax laws and regulations, changes in the mix of earnings among tax jurisdictions, changes in the valuation of our deferred tax assets and liabilities, vesting of equity awards at a price below the original valuation, historical entity classification elections, and the resolution of matters arising from tax audits.
We continue to be affected by U.S. healthcare reform initiatives. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (or collectively the "ACA"), has caused substantial changes to occur in recent years in the way healthcare is financed by both governmental and 28 private insurers.
We continue to be affected by U.S. healthcare reform initiatives. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (or collectively the "ACA"), has caused substantial changes to occur in recent years in the way healthcare is financed by both governmental and private insurers.
These agreements may be breached and there may not be adequate remedies in the event of a breach. Disputes may arise concerning the ownership of intellectual property or the applicability or enforceability of confidentiality agreements. Moreover, our trade secrets and proprietary technology may otherwise become known or be independently developed by our competitors or other parties.
These agreements 44 may be breached and there may not be adequate remedies in the event of a breach. Disputes may arise concerning the ownership of intellectual property or the applicability or enforceability of confidentiality agreements. Moreover, our trade secrets and proprietary technology may otherwise become known or be independently developed by our competitors or other parties.
There has been substantial litigation in the medical device industry with respect to the manufacture, use, and sale of new products. These lawsuits relate to the validity and infringement of patents or proprietary rights of third parties. We may be 45 required to defend against allegations relating to the infringement of patent or proprietary rights of third parties.
There has been substantial litigation in the medical device industry with respect to the manufacture, use, and sale of new products. These lawsuits relate to the validity and infringement of patents or proprietary rights of third parties. We may be required to defend against allegations relating to the infringement of patent or proprietary rights of third parties.
We believe it is important to provide investors with the same non-GAAP metrics that senior management uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to historical operating results and internally evaluate the effectiveness of our operating strategies.
We believe it is important to provide investors with the same non-GAAP metrics that senior management uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to historical operating results and internally evaluate 67 the effectiveness of our operating strategies.
In addition, if the market opportunities that we expect to develop for our products, including new products, are not as large as we expect, it could adversely affect our ability to grow our business. 36 It is also important that we carefully manage our introduction of new products and enhancements or modifications to our existing products.
In addition, if the market opportunities that we expect to develop for our products, including new products, are not as large as we expect, it could adversely affect our ability to grow our business. It is also important that we carefully manage our introduction of new products and enhancements or modifications to our existing products.
Competition for qualified personnel, particularly for key positions, is intense among companies in our industry, and many of the organizations against which we compete for qualified personnel have greater financial and other resources and different risk profiles than us, which may make them more attractive employers.
Competition for qualified personnel, particularly for key positions, is intense among companies in our industry, and many of the organizations against which we compete for qualified personnel have greater financial and other resources and different risk profiles than us, which may make them more attractive 37 employers.
He also has the following certifications: ISC2 CISSP, EC-Council Certified Ethical Hacker ("CEH"), and numerous vendor specific certifications. As cybersecurity risks arise, our Information Security team executes the incident response procedure and communicates the appropriate details to management in alignment with the escalation steps in the procedure.
He also has the following certifications: ISC2 CISSP, EC-Council Certified Ethical Hacker, and numerous vendor specific certifications. As cybersecurity risks arise, our Information Security team executes the incident response procedure and communicates the appropriate details to management in alignment with the escalation steps in the procedure.
Further, whether we directly manufacture a product or utilize a third-party manufacturer, shortages and spoilage of materials, labor stoppages, product recalls, manufacturing defects, and other similar events could delay production and inhibit our ability to bring a new product to market in timely fashion.
Further, whether we directly manufacture a product or utilize a third-party manufacturer, shortages and spoilage of materials, labor stoppages, product recalls, manufacturing defects, and other similar events could delay production 35 and inhibit our ability to bring a new product to market in timely fashion.
If the costs of maintaining adequate insurance coverage should increase significantly in the future, our operating results could be materially adversely impacted. 40 The physical effects of climate change or legal, regulatory, or market measures intended to address climate change could adversely affect our operations and operating results.
If the costs of maintaining adequate insurance coverage should increase significantly in the future, our operating results could be materially adversely impacted. The physical effects of climate change or legal, regulatory, or market measures intended to address climate change could adversely affect our operations and operating results.
All of our employees, including our management personnel, may terminate their employment with us at any time 43 without notice. If we cannot attract and retain highly qualified personnel as needed, we may not achieve our financial and other goals.
All of our employees, including our management personnel, may terminate their employment with us at any time without notice. If we cannot attract and retain highly qualified personnel as needed, we may not achieve our financial and other goals.
Newly acquired technology or products may require additional development efforts prior to commercial sale, including clinical testing and approval by the FDA and applicable foreign regulatory authorities; such additional development efforts may involve significant expense and ultimately be unsuccessful.
Newly acquired technology or products may require additional development efforts prior to commercial sale, including clinical testing and approval by the FDA and applicable foreign regulatory authorities; such 47 additional development efforts may involve significant expense and ultimately be unsuccessful.
Square Feet Ownership Manufacturing, warehousing, distribution, research and development, location of a cadaveric training laboratory, and administrative facility for corporate functions and all reporting segments Lewisville, TX 140,000 Leased Design, development, marketing, and inspection for biologics and spinal implant products, distribution of certain Spinal Implant products, location of a cadaveric training laboratory, and administrative facility Carlsbad, CA 82,000 Leased Manufacturing and distribution for certain Biologics products Irvine, CA 70,000 Leased Manufacturing, warehousing, distribution, research and development, and administrative facility for Motion Preservation Sunnyvale, CA 25,000 Leased Design of Spinal Implants and location of a cadaveric training laboratory Wayne, PA 3,700 Leased Design, development, and marketing for Enabling Technologies products Toronto, Canada 9,200 Leased Research and development, component manufacturing, quality control and training facility for Orthopedics products and sales management, distribution and administrative facility for Italy Verona, Italy 38,000 Owned International distribution center for Orthopedics products Verona, Italy 18,000 Leased Mechanical workshop for Orthopedics products Verona, Italy 9,000 Leased Sales management, distribution and administrative facility for United Kingdom Maidenhead, England 5,600 Leased Sales management, distribution and administrative facility for Brazil São Paulo, Brazil 26,300 Leased Sales management, distribution and administrative facility for France Arcueil, France 8,500 Leased Sales management, distribution and administrative facility for Germany Munich, Germany 2,300 Leased Our manufacturing facilities are registered with the FDA.
Square Feet Ownership Manufacturing, warehousing, distribution, research and development, location of a cadaveric training laboratory, and administrative facility for corporate functions and all reporting segments Lewisville, TX 140,000 Leased Design, development, marketing, and inspection for biologics and spinal implant products, distribution of certain Spinal Implant products, location of a cadaveric training laboratory, and administrative facility Carlsbad, CA 82,000 Leased Manufacturing and distribution for certain Biologics products Irvine, CA 70,000 Leased Manufacturing, warehousing, distribution, research and development, and administrative facility for Motion Preservation Sunnyvale, CA 25,000 Leased Design of Spinal Implants and location of a cadaveric training laboratory Wayne, PA 3,700 Leased Design, development, and marketing for Enabling Technologies products Toronto, Canada 9,200 Leased Research and development, component manufacturing, quality control and training facility for Limb Reconstruction products and sales management, distribution and administrative facility for Italy Verona, Italy 38,000 Owned International distribution center for Limb Reconstruction products Verona, Italy 18,000 Leased Mechanical workshop for Limb Reconstruction products Verona, Italy 9,000 Leased Sales management, distribution and administrative facility for United Kingdom Maidenhead, England 5,600 Leased Sales management, distribution and administrative facility for Brazil São Paulo, Brazil 26,300 Leased Sales management, distribution and administrative facility for France Arcueil, France 8,500 Leased Sales management, distribution and administrative facility for Germany Munich, Germany 2,300 Leased Our manufacturing facilities are registered with the FDA.
Ite m 1B. Unresolved Staff Comments None. Ite m 1C. Cybersecurity Risk Management and Strategy We have implemented cybersecurity programs designed to maintain and protect our information technology systems and the confidentiality, integrity, and availability of our data.
Ite m 1B. Unresolved Staff Comments None. 51 Ite m 1C. Cybersecurity Risk Management and Strategy We have implemented cybersecurity programs designed to maintain and protect our information technology systems and the confidentiality, integrity, and availability of our data.
Accordingly, and in line with 38 our vision to deliver clinical value, we have commenced clinical data collection activities for certain of our marketed products as more fully described elsewhere in this Item 1A.
Accordingly, and in line with our vision to deliver clinical value, we have commenced clinical data collection activities for certain of our marketed products as more fully described elsewhere in this Item 1A.
The preparation of these statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amount of revenues and 63 expenses during the reporting period.
The preparation of these statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amount of revenues and expenses during the reporting period.
An analysis was performed to determine the sensitivity 69 of our current year net sales and operating income to changes in foreign currency exchange rates. We determined that if the U.S.
An analysis was performed to determine the sensitivity of our current year net sales and operating income to changes in foreign currency exchange rates. We determined that if the U.S.
We strive to maintain sufficient inventory of products, raw materials, and components so that our production will not be significantly disrupted if a particular product, raw material, or component is not available to us for a period of time, including as a result of a supplier's loss of its International Organization of Standardization ("ISO") or other certification or as a result of any of the disruptions described above under the risk factor titled "If any of our manufacturing, development, or research facilities are damaged and/or if our manufacturing processes are interrupted, we could experience supply disruptions and/or lost revenues and our business could be seriously harmed including as the result of natural disasters and other catastrophic events outside our control." For example, a certain number of our products require titanium, which is sourced from third party suppliers.
We strive to maintain sufficient inventory of products, raw materials, and components so that our production will not be significantly disrupted if a particular product, raw material, or component is not available to us for a period of time, including as a result of a supplier's loss of its ISO or other certification or as a result of any of the disruptions described above under the risk factor titled "If any of our manufacturing, development, or research facilities are damaged and/or if our manufacturing processes are interrupted, we could experience supply disruptions and/or lost revenues and our business could be seriously harmed including as the result of natural disasters and other catastrophic events outside our control." For example, a certain number of our products require titanium, which is sourced from third-party suppliers.
We have reviewed these critical accounting estimates with the Audit and Finance Committee of the Board of Directors. Revenue Recognition The process for recognizing revenue involves significant assumptions and judgments for certain of our revenue streams.
We have reviewed these critical accounting estimates with the Audit and Finance Committee of the Board of Directors. 62 Revenue Recognition The process for recognizing revenue involves significant assumptions and judgments for certain of our revenue streams.
Dollar, any change in the values of those foreign currencies relative to the U.S. 48 Dollar could cause our profits to decrease or our products to be less competitive against those of our competitors.
Dollar, any change in the values of those foreign currencies relative to the U.S. Dollar could cause our profits to decrease or our products to be less competitive against those of our competitors.
In connection with the preparation and filing of this Annual Report, the Company’s management, including our President and Chief Executive Officer and our Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2024, based on the framework set forth in "Internal Control—Integrated Framework (2013)" issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria).
In connection with the preparation and filing of this Annual Report, the Company’s management, including our President and Chief Executive Officer and our Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025, based on the framework set forth in "Internal Control—Integrated Framework (2013)" issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria).
We cannot be certain that our supply of human tissue will be available from our suppliers at current levels or will meet our needs or that we will be able to successfully negotiate commercially reasonable terms with other accredited tissue banks. 42 If we are unable to maintain and expand our network of independent sales representatives and distributors, we may not maintain or grow our revenue.
We cannot be certain that our supply of human tissue will be available from our suppliers at current levels or will meet our needs or that we will be able to successfully negotiate commercially reasonable terms with other accredited tissue banks. 36 If we are unable to maintain and expand our network of independent sales representatives and distributors, we may not maintain or grow our revenue.
General or industry specific market conditions or stock market performance or domestic or international macroeconomic and geopolitical factors unrelated to our performance also may affect the price of our stock.
General or industry specific market 50 conditions or stock market performance or domestic or international macroeconomic and geopolitical factors unrelated to our performance may also affect the price of our stock.
Other Information During the fourth quarter of 2024, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted , modified or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any "non-Rule 10b5-1 trading arrangement."
Other Information During the fourth quarter of 2025, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted , modified or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any "non-Rule 10b5-1 trading arrangement."
Significant changes in these assumptions could result in a significantly higher or lower fair value. In April 2024, we converted the convertible loan into shares of Neo Medical preferred equity securities, which were recorded in other long-term assets and considered an investment that does not have a readily determinable fair value.
Significant changes in these assumptions could have resulted in a significantly higher or lower fair value. In April 2024, we converted the convertible loan into shares of Neo Medical preferred equity securities, which were recorded in other long-term assets and considered an investment that does not have a readily determinable fair value.
In addition, our Chief Information Officer, Vice President, Information Security, and Manager, Information Security, conduct monthly cybersecurity program status reviews with the Information Security team that includes key performance indicator ("KPI") tracking, risk assessment, escalation actions, and project status. 53 Ite m 2. Properties We lease or own real property to support our business.
In addition, our Chief Information Officer, Vice President, Information Security, and Manager, Information Security, conduct monthly cybersecurity program status reviews with the Information Security team that includes key performance indicator tracking, risk assessment, escalation actions, and project status. Ite m 2. Properties We lease or own real property to support our business.
We depend on third-party manufacturers for many of our products. We contract with third-party manufacturers to produce many of our products like many other companies in the medical device industry. If we or any such manufacturer fail to meet production and delivery schedules, it could have an adverse impact on our ability to sell such products.
We depend on third-party manufacturers for many of our products. We contract with third-party manufacturers to produce many of our products like many other companies in the medical device industry. If we or any such manufacturer fails to meet production and delivery schedules, it could have an adverse impact on our ability to sell such products.
Off-balance Sheet Arrangements As of December 31, 2024, we did not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, cash flows, liquidity, capital expenditures, or capital resources that are material to investors.
Off-balance Sheet Arrangements As of December 31, 2025, we did not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, cash flows, liquidity, capital expenditures, or capital resources that are material to investors.
Equity Compensation Plan Information Information about our equity compensation plan is incorporated herein by reference to Part III, Item 12 of this report. Recent Sales of Unregistered Securities During the fourth quarter of 2024, we did not issue any securities that were not registered under the Securities Act of 1933, as amended (the "Securities Act").
Equity Compensation Plan Information Information about our equity compensation plan is incorporated herein by reference to Part III, Item 12 of this report. Recent Sales of Unregistered Securities During the fourth quarter of 2025, we did not issue any securities that were not registered under the Securities Act of 1933, as amended (the "Securities Act").
Accounts receivable are analyzed on a quarterly basis to assess the adequacy of both reserves for expected credit losses and contractual allowances. Revisions in allowances for expected credit loss estimates are recorded as an adjustment to bad debt expense within sales, general, and administrative expenses. Revisions to contractual allowances are recorded as an adjustment to net sales.
Accounts receivable are analyzed on at least a quarterly basis to assess the adequacy of both reserves for expected credit losses and contractual allowances. Revisions in allowances for expected credit loss estimates are recorded as an adjustment to bad debt expense within sales, general, and administrative expenses. Revisions to contractual allowances are recorded as an adjustment to net sales.
Our allowance for credit losses and estimation of contractual allowances are "critical accounting estimates" because changes in the assumptions used to develop the estimates could materially affect key financial measures, including net sales, gross margin, operating income, adjusted EBITDA, net income, and accounts receivable.
Our allowance for credit losses and estimation of contractual allowances are "critical accounting estimates" because changes in the assumptions used to develop the estimates could materially affect key financial measures, including net sales, gross profit, operating income, adjusted EBITDA, net income, and accounts receivable.
This unsecured line of credit provides us the option to borrow amounts in Italy at rates which are determined at the time of borrowing. 62 Other For information regarding Contingencies, see Note 13 of the Notes to the Consolidated Financial Statements in Item 8 of this Annual Report.
This unsecured line of credit provides us the option to borrow amounts in Italy at rates which are determined at the time of borrowing. 61 Other For information regarding Contingencies, see Note 13 of the Notes to the Consolidated Financial Statements in Item 8 of this Annual Report.
Legal Proceedings For a description of material pending legal proceedings, refer to Note 13 of the Notes to the Consolidated Financial Statements in Item 8 of this Annual Report. It em 4 . Mine Safety Disclosures Not applicable. 54 PART II Ite m 5.
Legal Proceedings For a description of material pending legal proceedings, refer to Note 13 of the Notes to the Consolidated Financial Statements in Item 8 of this Annual Report. It em 4 . Mine Safety Disclosures Not applicable. 53 PART II Ite m 5.
In the event of a decrease in demand for our products, excess product production, or a higher incidence of inventory obsolescence, we could be required to increase our inventory reserves, which would increase cost of sales and decrease gross profit. We regularly evaluate our exposure for inventory write-downs.
In the event of a decrease in demand for our products, excess product production, or a higher incidence of inventory obsolescence, we may be required to increase our inventory reserves, which would increase cost of sales and decrease gross profit. We regularly evaluate our exposure for inventory write-downs.
Opinion on Internal Control Over Financial Reporting We have audited Orthofix Medical Inc.’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Orthofix Medical Inc.
Opinion on Internal Control Over Financial Reporting We have audited Orthofix Medical Inc.’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Orthofix Medical Inc.
Our Manager, Information Security, who reports to our Vice President, Information Security, is responsible for managing our security analyst and engineering team and is also responsible for the tactical execution of security operations. He has 25 years of experience in IT roles including 15 years of experience in security leadership.
Our Manager, Information Security, who reports to our Vice President, Information Security, is responsible for managing our security analyst and engineering team and is also responsible for the tactical execution of security operations. He has over 25 years 52 of experience in IT roles including 15 years of experience in security leadership.
Inventory Allowances Reserves for excess, slow moving, and obsolete inventory are calculated as the difference between the cost of inventory and market value and are based on assumptions and judgments about new product launch periods, overall product life cycles, forecasted demand, and market conditions.
Inventory Allowances Reserves for excess, slow moving, and obsolete inventory are calculated as the difference between the cost of inventory and net realizable value and are based on assumptions and judgments about new product launch periods, overall product life cycles, forecasted demand, and market conditions.
In addition, at Oxford's discretion, an additional $50.0 million of draw capacity is available to the Company, through January 1, 2029 (the "Term C Loan" and, together with the Term B Loan, the "Delayed Draw Term Loans" and collectively with the Initial Term Loan, the "Credit Facilities").
In addition, at Oxford's discretion, an additional $50.0 million of draw capacity is available through January 1, 2029 (the "Term C Loan" and, together with the Term B Loan, the "Delayed Draw Term Loans" and collectively with the Initial Term Loan, the "Credit Facilities").
Certain of the Company’s foreign subsidiaries joined the Credit Agreement as guarantors shortly after the signing date. The Credit Agreement provides for a $160.0 million senior secured term loan (the "Initial Term Loan"), and a $65.0 million senior secured delayed draw term loan facility (the "Term B Loan").
Certain of our foreign subsidiaries joined the Credit Agreement as guarantors shortly after the signing date. The Credit Agreement provides for a $160.0 million senior secured term loan (the "Initial Term Loan") and a $65.0 million senior secured delayed draw term loan facility (the "Term B Loan").
As of December 31, 2024, the step-up in fair value on acquired inventory was fully amortized. We estimated the fair value of the various classes of property, plant, and equipment acquired using the income approach, sales comparison approach, and the cost approach.
As of December 31, 2025, the step-up in fair value on acquired inventory was fully amortized. We estimated the fair value of the various classes of property, plant, and equipment acquired using the income approach, sales comparison approach, and the cost approach.
Dollar increased in value by 10% relative to all foreign currencies of our international operations it would result in a decrease in net sales of $9.5 million and a decrease in operating income of $0.3 million. I tem 8. Financial Statements and Supplementary Data See "Index to Consolidated Financial Statements" on page F-1 of this Annual Report. I tem 9.
Dollar increased in value by 10% relative to all foreign currencies of our international operations it would result in a decrease in net sales of $10.0 million and a decrease in operating income of $0.2 million. I tem 8. Financial Statements and Supplementary Data See "Index to Consolidated Financial Statements" on page F-1 of this Annual Report. I tem 9.
This could be due to a number of factors, including, but not limited to, perceived deficiencies, or gaps, in our existing product portfolio, intense competition for services of independent sales representatives and distributors, or the disruption associated with restrictive covenants to which representatives or distributors may be subject and potential litigation and expenses associated therewith.
This could be due to a number of factors, including, but not limited to, perceived deficiencies, or gaps, in our existing product portfolio, intense competition for services of independent sales representatives and distributors, unreasonable demands by existing independent sales representatives and distributors, or the disruption associated with restrictive covenants to which representatives or distributors may be subject and potential litigation and expenses associated therewith.
Additional lawsuits or proceedings against the Company and/or its current or former directors and officers in connection with these matters may be filed in the future. 47 In the event that any of these claims, or other future related or unrelated claims, are successful, they could result in costs to us that could negatively affect our near-term liquidity and financial condition.
Additional lawsuits or proceedings against the Company and/or its current or former directors and officers in connection with these matters may be filed in the future. In the event that any of these claims, or other future related or unrelated claims, are successful, they could result in costs to us that may negatively affect our liquidity and financial condition.
We are subject to the Foreign Corrupt Practices Act (the "FCPA") and other similar anti-bribery laws, and any violations of such laws could subject us to adverse consequences. The FCPA and similar anti-bribery laws in non-U.S. jurisdictions generally prohibit companies and their intermediaries from making improper payments to foreign government officials for the purpose of obtaining or retaining business.
We are subject to the FCPA and other similar anti-bribery laws, and any violations of such laws could subject us to adverse consequences. The FCPA and similar anti-bribery laws in non-U.S. jurisdictions generally prohibit companies and their intermediaries from making improper payments to foreign government officials for the purpose of obtaining or retaining business.
Our fair value measurements are a "critical accounting estimate" because changes in the assumptions used to develop the estimate could materially affect key financial measures, including operating income and net income.
Our fair value measurements are a "critical accounting estimate" because changes in the assumptions used to develop the estimate could materially affect key financial measures, including operating income, adjusted EBITDA, and net income.
These fair value measurements are a "critical accounting estimate" because changes in the assumptions used to develop the estimate could materially affect key financial measures, including operating income and net income.
These fair value measurements are a "critical accounting estimate" because changes in the assumptions used to develop the estimate could materially affect key financial measures, including operating income, adjusted EBITDA, and net income.
However, the E.U. MDR, which replaced the prior medical device directives in May 2021, require submission of certain pre- and post-market data to maintain our CE marks.
However, the E.U. MDR, which replaced the prior medical device directives in May 2021, requires submission of certain pre- and post-market data to maintain our CE marks.
These estimates include the amount and timing of projected future cash flows, royalty savings, and the discount rate used to discount those cash flows to present value. We estimated the fair value of acquired right-of-use assets and assumed lease liabilities acquired in connection with the Merger using the yield capitalization method of the income approach.
These estimates 65 included the amount and timing of projected future cash flows, royalty savings, and the discount rate used to discount those cash flows to present value. We estimated the fair value of acquired right-of-use assets and assumed lease liabilities acquired in connection with the Merger using the yield capitalization method of the income approach.
We are exposed to interest rate risk in connection with the outstanding debt related to our Initial Term Loan, which bears interest at floating rates based on a three-month Secured Overnight Financing Rate, or SOFR, plus an applicable borrowing margin or at a base rate (as defined in the Credit Agreement) plus an applicable borrowing margin.
We are exposed to interest rate risk in connection with the outstanding debt related to our Initial Term Loan, which bears interest at floating rates based on a three-month SOFR plus an applicable borrowing margin or at a base rate (as defined in the Credit Agreement) plus an applicable borrowing margin.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, changes in shareholders' equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes and our report dated February 25, 2025 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, changes in shareholders' equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes and our report dated February 24, 2026 expressed an unqualified opinion thereon.
Performance Graph The following performance graph is not deemed to be "soliciting material" or to be "filed" with the SEC or subject to Regulation 14A or 14C or to the liabilities of Section 18 of the Exchange Act.
Performance Graph The following performance graph is not deemed to be "soliciting material" or to be "filed" with the SEC or subject to Regulation 14A or 14C or to the liabilities of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act").
For revenue derived from third-party payors, including commercial insurance carriers, health maintenance organizations, preferred provider organizations, and governmental payors, such as Medicare, in connection with the sale of our Bone Growth Therapies products, we recognize revenue when the stimulation product is fitted to and accepted by the patient and all applicable documents that are required by the third-party payor have been obtained.
For revenue derived from third-party payors, including commercial insurance carriers, health maintenance organizations, preferred provider organizations, and governmental payors, such as Medicare, in connection with the sale of our BGT products, we recognize revenue when the stimulation product is fitted to and accepted by the patient and all applicable documents that are required by the third-party payor have been obtained.
Bone Growth Therapies uses distributors and a direct sales channel to sell its devices and provide associated support services to hospitals, healthcare providers, and patients in the U.S. - Spinal Implants, Biologics, and Enabling Technologies is comprised of a broad portfolio of spine fixation and motion preservation implant products used in surgical procedures of the spine, one of the most comprehensive biologics portfolios in both the demineralized bone matrix and cellular allograft market segments, and image-guided surgical solutions to facilitate degenerative, minimally invasive, and complex surgical procedures.
BGT uses distributors and a direct sales channel to sell its devices and provide associated support services to hospitals, healthcare providers, and patients in the U.S. - Spinal Implants, Biologics, and Enabling Technologies is comprised of a broad portfolio of spine fixation implant products used in surgical procedures of the spine, one of the most comprehensive biologics portfolios in both the demineralized bone matrix and cellular allograft market segments and image-guided surgical solutions to facilitate degenerative, minimally invasive, and complex surgical procedures.
The U.S. Dollar equivalent of international sales denominated in foreign currencies was unfavorably impacted during the year ended December 31, 2024, and favorably impacted during the year ended December 31, 2023, by monthly foreign currency exchange rate fluctuations of the U.S. Dollar against all of the foreign functional currencies for our international operations.
The U.S. Dollar equivalent of international sales denominated in foreign currencies was favorably 68 impacted during the year ended December 31, 2025, and unfavorably impacted during the year ended December 31, 2024, by monthly foreign currency exchange rate fluctuations of the U.S. Dollar against all of the foreign functional currencies for our international operations.
The import and export of our products involve subsidiaries and third parties operating in jurisdictions with different customs and import/export rules and regulations. Customs authorities in such jurisdictions may challenge our treatment of customs and import/export rules relating to product shipments under aspects of their respective customs laws and treaties.
The import and export of our products involve subsidiaries and third parties operating in jurisdictions with different customs and import/export rules and regulations. Customs authorities in the U.S. and/or such jurisdictions may challenge our treatment of customs and import/export rules relating to product shipments under aspects of their respective customs laws and treaties.
Spinal Implants and Global Orthopedics products are distributed world-wide, with U.S. sales largely comprised of commercial revenue and international sales derived from commercial sales and through stocking distributor arrangements. Commercial revenue is largely related to the sale of our Spinal Implants and Global Orthopedics products to hospital customers.
Spinal Implants and Global Limb Reconstruction products are distributed world-wide, with U.S. sales largely comprised of commercial revenue and international sales derived from commercial sales and through stocking distributor arrangements. Commercial revenue is largely related to the sale of our Spinal Implants and Global Limb Reconstruction products to hospital customers.

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