Orthofix Medical Inc.’s (Orthofix) operates as a global medical technology company.
Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics, and enabling technologies, including the 7D FLASH navigation system.
Business Segments
The company operates through two segments: Global Spine and Global Orthopedics segments.
Global Spine Strategy
Within the Global Spine segment, the company provides implantable medical devices,...
Orthofix Medical Inc.’s (Orthofix) operates as a global medical technology company.
Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics, and enabling technologies, including the 7D FLASH navigation system.
Business Segments
The company operates through two segments: Global Spine and Global Orthopedics segments.
Global Spine Strategy
Within the Global Spine segment, the company provides implantable medical devices, biologics, enabling technologies, and other regenerative solutions which aim to restore the quality of life of patients suffering from diseases and traumas of the spine. The company offers a variety of treatment solutions that uniquely incorporate multiple treatment modalities, such as mechanical, biological, and electromagnetic modes, to achieve desired clinical outcomes.
Strategy
The company’s strategy for the Global Spine segment is to drive business growth through organic and inorganic innovation, physician collaboration, and partnerships with dedicated and high-performing commercial sales channels. Growth initiatives include:
A regular cadence of new and differentiated product launches supporting its spine implant and enabling technologies, biologics, and bone growth therapies portfolios;
Ongoing, global sales channel optimization and expansion;
Reinforcement of the company’s 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 its spine implant, biologics, and bone growth stimulation portfolios;
Acquiring or licensing products, technologies, and companies to further expand and enhance the company’s spine portfolio;
Investing in the further development of its pre-clinical and clinical programs designed to generate peer-reviewed scientific evidence in support of its products; and
Attracting, developing, and retaining key talent.
Global Spine Principal Products
The Global Spine reporting segment is largely represented by two principal product categories: Bone Growth Therapies; and Spinal Implants, Biologics, and Enabling Technologies. Each of these product categories, and their significant components, are further described below.
Bone Growth Therapies
Within the Bone Growth Therapies product category, the company manufactures, distributes, and provides support services for market-leading bone growth stimulation devices that enhance bone fusion. These Class III medical devices are indicated as an adjunctive, noninvasive treatment to improve fusion success rates in the cervical and lumbar spine as well as a therapeutic treatment for non-spinal, appendicular fractures, treating both fresh fractures and fractures that have not healed (‘nonunions’). Several devices in the company’s portfolio utilizes its 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. A new addition to the company’s stimulation portfolio utilizes its low intensity pulsed ultrasound (LIPUS), a technology also supported by strong basic science and published clinical literature. Orthofix is the only manufacturer which offers both PEMF and LIPUS technologies. The company sells these products almost exclusively in the United States (U.S.), using distributors and direct sales representatives to provide the company’s devices to healthcare providers and their patients.
Within the Bone Growth Therapies product category, the company manufactures, distributes, and provides support services for market-leading bone growth stimulation devices that enhance bone fusion. These class III medical devices are indicated as an adjunctive, noninvasive treatment to improve fusion success rates in the cervical and lumbar spine, as well as a therapeutic treatment for non-spinal, appendicular fractures that have not healed ('nonunions'). Several devices in the company's portfolio utilize its 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. A new addition to the company's stimulation portfolio utilizes the company's low intensity pulsed ultrasound ('LIPUS'), a technology also supported by strong basic science published clinical literature. Orthofix is the only manufacturer which offers both PEMF and LIPUS technologies. The company sells these products almost exclusively in the U.S., using distributors and direct sales representatives to provide the company's devices to healthcare providers and their patients.
Spinal Implants
Within Spinal Implants, the company designs, develops, and markets a portfolio of spine fixation implant products for broad spectrum use throughout the entire spinal column. Such products are typically used to facilitate fusion in degenerative, minimally invasive, and complex spinal deformity procedures throughout the lumbar, thoracic, sacral, and cervical regions of the spine. The company distributes these products globally through a network of distributors and sales representatives to sell spine products to facilities that conduct spine care, including hospitals, ambulatory surgery centers, as well as out-patient hospitals.
Enabling Technologies
Within Enabling Technologies, the company designs, develops, and markets a portfolio of navigation technologies including tracked surgical tools, intelligent software and imaging equipment based on Machine-Vision and optical innovations. Specifically, the company’s 7D FLASH Navigation System has redefined image guided surgery, delivering a navigation platform with meaningful benefits in spine and cranial procedures. The speed, accuracy, workflow efficiency, and intraoperative radiation-free safety profile of the 7D FLASH Navigation System delivers significant economic value, while eliminating the long-standing frustrations and challenges of traditional image guided navigation systems. The company distributes these products globally through a network of direct sales representatives and distributors to facilitate pediatric, adolescent, and adult procedures in hospitals, ASCs, and out-patient facilities.
Biologics
Within the Biologics product category, the company offers a portfolio of bone graft substitutes intended to address the key elements of bone regeneration that allow physicians to successfully treat a variety of spinal, orthopedic, and dental conditions. The company's Biologics portfolio includes fiber-based and particulate demineralized bone matrices (DBMs), as well as cellular bone allografts, collagen ceramic matrices, and synthetic bone void fillers in various forms, with supporting graft delivery solutions to address a wide range of clinical applications. Distributed globally through a network of distributors and sales representatives, the company's portfolio is a mix of internally manufactured tissues and products, as well as marketed tissue forms provided by MTF Biologics. The breadth of the product offering, and data-supported product lines position it with greater access to facilities, including group purchasing organizations (GPOs)/integrated delivery networks (IDNs), hospitals, and ASCs.
Bone Growth Therapies Products
CervicalStim Spinal Fusion Therapy: PEMF non-invasive cervical spinal fusion therapy used to enhance bone growth.
SpinalStim Spinal Fusion Therapy: PEMF non-invasive lumbar spinal fusion therapy used to enhance bone growth.
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.
Spinal Implants and Enabling Technologies Products
Posterior Thoracolumbar Fixation Procedures: Pedicle screw systems for open and minimally invasive surgery (MIS) procedures and adult deformity procedures featuring modular technology and accompanying instrumentation designed to reduce the number of trays needed for surgery and that provides surgeons with multiple intra-operative options to facilitate posterior thoracolumbar fixation. The company also provides powerful instrumented compression and distraction of the spine. Products include the company’s Mariner, Firebird, Firebird NXG, Janus, Daytona, Newport, and Phoenix product lines. These brands also include several different screw types including, cannulated, fenestrated, hydroxyapatite (HA) coated, and cortical cancellous. These options give surgeons a full portfolio of choices for their patients without having to utilize several different screw systems.
Artificial Cervical Disc Replacement Procedures: The company’s next-generation artificial disc, M6-C artificial cervical disc, developed to replace an intervertebral disc damaged by cervical disc degeneration is the only artificial cervical disc that mimics the anatomic structure of a natural disc by incorporating an artificial viscoelastic nucleus and fiber annulus into its design. In February 2025, the company announced the discontinuation of the M6 line of products.
Artificial Lumbar Disc Replacement Procedures: The company’s next-generation artificial disc, M6-L artificial lumbar disc, developed to replace an intervertebral disc damaged by lumbar disc degeneration; the only artificial lumbar disc that mimics the anatomic structure of a natural disc by incorporating an artificial viscoelastic nucleus and fiber annulus into its design. (Not available in the U.S.) In February 2025, the company announced the discontinuation of the M6 line of products.
Anterior Lumbar Interbody Fusion (ALIF) Procedures: A complete portfolio of ALIF products, including interbody spacers, disc preparation instruments, access systems, and plating/fixation options. The company’s spacers come in a variety of material options including polyetheretherketone (PEEK), PEEK Titanium composite (PTC), and 3D printed Titanium. Some of the company’s products also contain U.S. Food and Drug Administration (FDA) cleared Nano surface technology (Nanovate) that is scientifically proven to upregulate osteogenic factors in vitro. The multiple material types allow surgeons to select the material best for their patients. These products also come in a variety of footprints and lordotic options. The interbodies come with a large graft area to accommodate the addition of biologics to aid in the fusion process. Some of the company’s interbodies include integrated fixation to eliminate the need for additional fixation. These variations provide a complete list of options for the ALIF procedural category. The company’s main contributors to this category include Meridian, Waveform A, Reef A, and Pillar SA PTC.
Posterior Cervical Fixation Procedures: The company provides spinal fixation systems with novel instrumentation and anatomically designed implants to provide a safe and effective solution designed to improve surgical flow when navigating through complex posterior cervical procedures. These products include a wide array of screws, rods, and instruments to aid surgeons in performing these procedures. These products include Northstar occipital cervical thoracic (OCT) and Centurion.
Posterior Lumbar Interbody Fusion (PLIF)/ Transforaminal Lumbar Interbody Fusion (TLIF) Procedures: The company’s PLIF/TLIF portfolio includes a variety of interbodies, as well as several disc prep and access options. The interbodies come in both straight and curved footprints to accommodate surgeons in placement of the interbodies, and a choice of materials from PEEK, PEEK Titanium Composite, and 3D printed Titanium. Some of the company’s products also contain FDA-cleared Nanovate that is scientifically proven to upregulate osteogenic factors in vitro. The company’s main products in the static PLIF/TLIF interbodies are Waveform TA/TO, Reef TA/TO, and Forza. The company’s straight products category contains both traditional static interbodies as well as expandable options. These options include both its Forza XP and Explorer TO product lines. These expandable options allow surgeons to minimize their exposure and expand the interbody in-situ to the preferred height and lordosis that best suits their patient. To aid in access the company also offers several retractor options with its latest screw-based retractor called Fathom.
Lateral Lumbar Interbody Fusion (LLIF) Procedures: The LLIF portfolio includes a comprehensive range of interbodies, additional fixation options, retractor access systems, and disc preparation instrumentation. The company’s interbodies come in a variety of footprint and lordotic options, as well as in a number of material types, including PEEK, PEEK Titanium composite, and 3D printed Titanium. The company’s main LLIF interbody brands offered by the company is Regatta Lateral and Waveform L. These interbodies can be paired with the Regatta plate to provide auxiliary fixation during the LLIF procedure. The Lattus Retractor is the company’s newest market-leading access retractor, providing surgeons the ability to access the disc space and conduct the LLIF procedure. This pairs seamlessly with several lateral disc preparation options that aid surgeons in completing their discectomy prior to interbody placement.
Anterior Cervical Discectomy and Fusion (ACDF) Procedures: The ACDF portfolio includes interbodies with and without integrated fixation and plating systems to provide fixation of the anterior cervical spine. The company’s cervical interbodies come in a wide variety of footprints and lordotic options, as well as material options, giving surgeons the ability of choice to accommodate their patient populations. The company’s top producing cervical interbodies include Waveform C, and its Construx brands. The Shoreline product brand provides the ability to turn interbodies without integrated fixation into fixated spacers, reducing time surgeons spend in the operating room and making it seamless to fixate interbodies into the disc space. When selecting an interbody without fixation an anterior cervical plate is needed. The company’s top brands of cervical plates are Admiral and Cetra. In addition to these options, the company also offers several different disc and endplate preparation options to satisfy the ACDF procedure.
Revision Surgical Procedures: As an adjunct to the company’s posterior lumbar fixation portfolio, the company offers two main products, Mariner Outrigger and Connectors, that are designed to help surgeons tackle difficult revision cases. 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.
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. Firebird SI is one of the only 3D printed Titanium products on the market and the only 3D printed product that also has nanotechnology claims with the company’s Nanovate technology.
Other procedures: Corpectomy, Laminoplasty, Jazz Bands: Outside of the main spinal procedural categories, the company also offers several products in areas such as corpectomy (VuMesh), laminoplasty (Newbridge), and a unique product, Jazz Bands. 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.
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. This advanced navigation system enables a fully contactless workflow by seamlessly tracking disposable surgical instruments via integrated LiveTrack tile markers, ensuring precise surgical navigation for external ventricular drain bedside procedures.
Proprietary Technology: Accell Bone Matrix (ABM) An open structured, dispersed form of DBM is offered by the company, which increases the bioavailability of bone proteins at an earlier stage in the healing cascade. When combined with traditional DBM, both fibers and particulate forms, it provides a biphasic release of growth factors to promote healing. Accell is a technology featured in several key DBM products, including, but not limited to, Strand Plus and Evo3.
Demineralized Bone Fibers (DBF): Strand, Strand Plus, Fiberfuse DBFs are designed to facilitate and aid in fusion by maximizing osteoinductive content while providing an improved conductive matrix. Multiple compositions include 100% fibers, fibers with ABM, and fibers mixed with cancellous bone. Provided in both putty and strip formulations.
Demineralized Bone Putty: Evo3/Evo3c, Torrent/Torrent C, DynaGraft II, OrthoBlast II, Legacy Flowable DBMs designed with putty-like handling characteristics to ease graft placement and conform to any bony anatomy to aid in bone fusion. Provided in multiple compositions of DBM particulate and carrier with and without Accell Bone Matrix or with and without cancellous bone.
Cellular Bone Matrixes (CBM): The company offers Trinity Elite and Virtuos Lyograft, which are comprises demineralized cortical bone fibers and cancellous bone with retained cells. Cellular allografts are used during surgeries designed to aid in the success of spinal fusion or bone fusion procedures. These products are provided in either a cryopreserved or shelf-stable form.
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. Ballast, Ballast MT: Resorbable mesh filled with 100% DBM, or provided empty; aids in simplifying graft placement and prevents graft migration for posterolateral fusion; NorthStar Facet Fusion, Flash Facet Fusion: Novel procedural solution for reproducible biologic placement within the facet joint for cervical and lumbar spine. Systems includes pre-shaped demineralized bone fibers with single-use instrumentation for facet prep and biologic delivery; RAPID, O-Genesis: Reusable and sterile, single use options to aid in bone graft delivery to the surgical site.
Other: Versashield A thin hydrophilic amniotic membrane designed to serve as a wound covering and protective barrier for a variety of surgical demands.
Bone Growth Therapies: Spinal Therapy
The company's bone growth therapy devices used in spinal applications are designed to enhance bone growth and improve the success rate of certain spinal fusion procedures by stimulating the body’s own natural healing mechanism post-surgically. These non-invasive portable devices are intended to be used as part of a home treatment program prescribed by a physician.
The company offers two spinal fusion therapy devices: the SpinalStim and CervicalStim devices. The company's stimulation products utilize PEMF technology designed to enhance the growth of bone tissue following surgery and are placed externally over the site to be healed. Research data shows that the company's PEMF signal induces mineralization and results in a process that stimulates new regeneration at the spinal fusion site. Some spine fusion patients are at greater risk of not achieving a solid fusion of new bone around the fusion site. These patients typically have one or more risk factors, such as smoking, obesity, or diabetes, or their surgery involves the revision of a failed fusion or the fusion of multiple levels of vertebrae in one procedure. For these patients, post-surgical bone growth therapy has been shown to significantly increase the probability of fusion success.
The SpinalStim device is a non-invasive spinal fusion stimulator system designed for the treatment of the lumbar region of the spine. The device utilizes proprietary technology and a specific wavelength to generate a PEMF signal. The FDA has approved the SpinalStim system as a spinal fusion adjunct to increase the probability of fusion success, as well as a non-operative treatment for the salvage of failed spinal fusion at least nine months post-operatively.
The CervicalStim product remains the only FDA-approved bone growth stimulator on the market indicated for use as an adjunct to cervical spine fusion surgery. It is specifically 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. 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.
Bone Growth Therapies: Orthopedic Therapy
The company's PhysioStim bone healing therapy products utilize PEMF technology similar to that used in its spine stimulators. The primary difference is that the PhysioStim devices are designed for use on the appendicular skeleton.
A bone’s regenerative power results in most fractures healing naturally within a few months. However, in the presence of certain risk factors, some fractures do not heal or heal slowly, resulting in nonunions. Traditionally, orthopedists have treated such nonunion conditions surgically, often by means of a bone graft with fracture fixation devices, such as bone plates, screws, or intramedullary rods. These are examples of invasive treatments. The company's patented PhysioStim bone healing therapy products are designed to use a low level of PEMF signals to noninvasively activate the body’s natural healing process. The devices are anatomically designed, allowing ease of placement, patient mobility, and the ability to cover a large treatment area.
Similar to the 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.
The AccelStim device provides a safe and effective nonsurgical treatment to improve nonunion fracture healing and accelerate the healing of indicated fresh fractures. The device stimulates the bone’s natural healing process through LIPUS waves directed to the fracture site.
Spinal Implants: Spinal Fixation Solutions
The company provides a wide range of implants and fixation products for use in spinal surgery, covering the entire spine from occiput to sacrum. Below is a discussion of the company's portfolio based on the segmentation of its internal franchise groups:
Cervical
The company's cervical portfolio includes fixation, interbodies, and plates. The interbody spacer brands and materials include PTC, Waveform, Reef, and Nanovate 3D printed titanium surface technologies. Each option comes with different material, clinical, and handling characteristics, allowing clinicians to make the appropriate choice for their patients. Some of the company's spacers also offer the option for integrated fixation, which eliminates the necessity for additional fixation. In addition to the spacers, the company's surgical-grade titanium plating systems, Admiral and Cetra, allow for anterior fixation of the cervical spine. Lastly, for posterior fixation, the company offers two systems, Northstar OCT and Centurion, as well as a laminoplasty system, Newbridge. These systems are comprehensive, comprising rods, connectors, and screws that are implanted for posterior fixation.
Interbody
The company's robust interbody group offers 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. The anterior lumbar portfolio includes 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. The lateral portfolio takes full advantage of the company's top-of-the-line retractor systems to gain access to the disc space. This portfolio is complete with highly competitive footprints and plating options as well. Brands in the lateral portfolio include Skyhawk, Regatta L, and Waveform L, which are utilized in direct lateral, prone lateral, and anterior to the psoas procedures.
The posterior portfolio, utilized for PLIF and TLIF procedures, has two key segmentations: static and expandable. The expandable posterior interbodies allow for a smaller incision and smaller exposure, which then expands to create or fill the space of the disc space. The expandable brands include Forza XP, the company’s top-performing interbody implant, and Explorer TO. In the static posterior interbodies, the company offers several brands serving all material types and providing both straight and curved footprints to aid in posterior procedures. These brands include Forza, Forza PTC, Forza Ti, Waveform TA/TO, and Reef TA/TO.
Thoracolumbar
In the company's thoracolumbar franchise, there is a complete line of fixation products for degenerative spinal conditions, as well as for complex deformity, midline, and revision cases. The posterior brands are all modular, meaning surgeons have the option to select from several different screw shank varieties, including cannulated, fenestrated, HA coated, cortical cancellous, and a traditional dual lead option. This design allows the surgeon to maintain the instrumentation of the parent system while selecting the appropriate screw shank for the patient, offering maximum clinical value. The Firebird/Firebird NXG, Phoenix, and Mariner brands are available for open or minimally invasive procedures and include options such as connectors, mono axial screws, and many more instrumentation options to aid in a variety of cases. Additionally, within this franchise group is the SI fixation product, Firebird SI, which is the first 3D printed SI fixation product and one of the only such products with nanotechnology claims.
Enabling Technologies
The company's machine vision 7D FLASH Navigation System is used in a variety of posterior spinal procedures, including degenerative, deformity, tumor, trauma, and revision surgery. The system can be utilized in MIS/percutaneous, mini-open, or open techniques. Additionally, the technology offers a comprehensive cranial platform for use in cranial neurosurgery.
The company's innovative 7D FLASH Navigation System delivers a comprehensive navigation platform that utilizes visible light, machine-vision cameras, and intelligent software algorithms to create a 3D image within seconds for surgical navigation. This novel technology allows for fast image reconstruction for surgical navigation with no disruption to surgeon workflow and eliminates radiation exposure during the procedure for the patient, surgeon, and operating room staff.
The company's Spine Module is the leading product in the FLASH Navigation Portfolio. In 2024, the company further enhanced the 7D FLASH Navigation System with the release of its 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. Traditional spine navigation requires a preoperative CT or intraoperative radiation for image acquisition and registration. The 7D MRVision is the first and only solution that eliminates radiation from the entire navigation workflow. Further enhancements and new features for the Spine Module and Percutaneous Module are in development and are expected to launch in 2025.
In addition to these new products focused on spine, the FLASH Navigation Portfolio also includes the Cranial Module for use in cranial surgeries. The technology employs a completely contactless workflow, acquiring hundreds of thousands of virtual fiducials using the patient’s own anatomy, resulting in nearly instantaneous cranial registrations to the skin or skull in almost any surgical position. In 2025, the company anticipates the commercial launch of FLASH EVD, a new mobile bedside navigational system leveraging 7D FLASH Technology designed for fast and reliable EVD placement. Cadaveric testing has been completed, and FLASH EVD achieved FDA 510K clearance in December 2024.
Biologics: Regenerative Solutions
The company’s biologics portfolio is focused on best-in-class bone grafting solutions from each of the major bone grafting categories - demineralized bone, cellular allografts, and synthetics. The breadth of the portfolio within each segment allows for a consultative approach with both physicians and hospitals to determine the best product based on clinical performance and price.
The company’s 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. This internally processed, proprietary technology is an open structured, dispersed form of DBM, which increases the bioavailability of bone proteins at an earlier time in the healing cascade. When combined with traditional DBM, it provides a biphasic release of growth factors to promote healing.
The company's cellular allografts portfolio features a market-leading graft with Trinity Elite and the recently released Virtuous Lyograft, both co-branded with MTF Biologics. Trinity Elite, an allograft containing viable cells, has maintained its position as a market leader with over a decade of clinical evidence and a series of peer-reviewed publications. Virtuous Lyograft is particularly unique, as it is a first-of-its-kind, shelf-stable cellular allograft for spine and orthopedic procedures, provided in a room-temperature, ready-to-use, moldable form.
Regarding synthetic solutions, the company's focus products are Cove and Mozaik. Cove, an advanced bioactive synthetic, is the newest introduction into this segment. Cove features a unique surface topography of the ß-TCP and HA granule and has demonstrated the ability to grow bone in a muscle pouch. Additionally, Cove possesses handling characteristics ideal for ensuring that graft placement remains where it is needed. The combination of Cove and Mozaik provides different value options within this portfolio to meet varying customer needs.
In addition to each of the major categories, the company has continued to invest in products that address specific procedural and clinical needs. The company’s solutions address many of the issues that physicians see with graft delivery and containment within the surgical site. Several of its 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 its products while driving better clinical outcomes.
In addition to each of the major categories, the company has continued to invest in products that address specific procedural and clinical needs. The company's solutions tackle many of the issues that physicians encounter with graft delivery and containment within the surgical site. Several of these solutions address this through handling characteristics of the product, shape and design, instrumentation to aid delivery, or even added materials to assist in graft containment. All of these solutions are aimed at improving the ease of use and consistency of the company's products while driving better clinical outcomes.
The company receives marketing fees through its 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. The company holds exclusive worldwide rights to market Virtuous and Trinity Elite, as well as exclusive rights to market FiberFuse tissues in the U.S.
The company's other leading tissue forms and synthetics, such as Strand Plus, Strand, Evo3, Evo3c, Ballast, Cove, and Mozaik, are all processed internally through IsoTis Orthobiologics. This completely integrated business unit allows for a continuous feedback cycle with research and development, marketing, manufacturing, and quality to ensure high-quality products are delivered with consistent customer fulfillment.
To date, the company 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.
Global Spine Future Product Applications
The company remains very active with multiple internal developments to support new technology commercialization efforts. These new technologies apply to both the cervical and thoracolumbar spinal anatomy. The company expects that the contribution of new, internally developed technologies and any future external acquisitions will be the primary driver of future growth.
Regarding the Bone Growth Therapy business, the company has participated in research at Wake Forest University Health Sciences, 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 its PEMF signals on bone, cartilage, meniscus, nerve, and the efficacy of healing. From these efforts, some studies have been published in peer-reviewed journals. Among other insights, the studies illustrate positive effects of PEMF on callus formation and bone strength, meniscus and nerve injury repair, as well as proliferation and differentiation of cells involved in tissue regeneration and healing.
Furthermore, the previous research work with Cleveland Clinic, the Chinese University of Hong Kong, and the University of Pennsylvania, which allowed for characterization and demonstration of the company's new PEMF waveform, is paving the way for signal optimization for a variety of new applications and indications. This collection of pre-clinical data, along with additional clinical data, could represent new clinical indication opportunities for the company's regenerative stimulation solutions.
Global Orthopedics
The Global Orthopedics reporting segment offers products and solutions for the underserved limb reconstruction market, which encompasses four pillars: deformity correction, limb lengthening, complex fracture management, and limb preservation. This reporting segment specializes in the design, development, and marketing of external and internal fixation orthopedic products that are coupled with enabling digital technologies to serve the complete patient treatment pathway. The company sells these products through a global network of distributors and sales representatives to hospitals, healthcare organizations, and healthcare providers.
Global Orthopedics Strategy
The company’s 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.
The company’s key strategies in this segment are:
Expand its position as the worldwide leader in limb reconstruction, including both internal and external solutions, through a patient-centric approach and digital treatment journey;
Leverage the company’s cross-product OrthoNext digital platform, a uniquely developed pre and post planning, software that allows its 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 its historical position as a leader in 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 the company’s 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 the company’s flagship TrueLok system, comprises 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 its 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.
Global Orthopedics Focus Products
Global Orthopedics offers a comprehensive line of limb reconstruction technologies that address the most complex patient conditions within deformity correction, limb lengthening, complex fracture management, and limb preservation. The company provides innovative external and internal solutions to help surgeons improve the quality of life for patients of all ages.
The following observations identifies the principal Global Orthopedics products by trade name and describes their primary applications:
TrueLok: A surgeon-designed, lightweight external fixation system for complex fracture management, limb lengthening, limb preservation, and deformity correction, which consists of circular rings and semi-circular external supports centered on the patient’s limb and secured to the bone by crossed, tensioned wires and half pins.
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. 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.
TrueLok EVO: The company offers 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, providing surgeons with clear radiographic visualization to better assess bone anatomy both during surgery and in post-operative care.
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.
Galaxy Fixation System: A pin-to-bar system for temporary and definitive fracture fixation, in the upper and lower limbs. Available in sterile kits, the system incorporates a streamlined combination of clamps, with both pin-to-bar and bar-to-bar coupling capabilities, offering a complete range of applications, including specific anatomic units for the shoulder, elbow, and wrist. The latest version, Galaxy Gemini, includes a universal clamp and other updates to better streamline surgical procedures.
Galaxy Fixation Shoulder: A unique solution for the treatment of proximal humeral fractures.
Ankle Hindfoot Nail (AHN): A differentiated solution for hindfoot fusions that includes a revision option to address larger bone defects and more complex hindfoot pathologies.
G-BEAM Fusion Beaming System: A system designed to address the specific demands of advanced deformity and trauma reconstructions of foot and ankle applications, such as Charcot, requiring fusion of the medial and/or lateral columns, with or without corrective osteotomies, as well as for joint fusions within the mid- and hindfoot.
OSCAR: An ultrasonic powered surgical system for revision hip and knee arthroplasty.
External Fixators: External fixation, including its limb-lengthening systems, ProCallus, XCaliber, Pennig, Radiolucent Wrist Fixators, and Calcaneal Fixator.
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.
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.
External Fixation
External fixation devices are utilized to correct bone deformities, stabilize fractures, and provide an ideal treatment for patients with known risk factors or co-morbidities. The treatment is minimally invasive and allows for external manipulation of the bone to obtain and maintain final bone alignment (reduction). The bone is fixed in this manner until healing occurs. External fixation permits small degrees of micromotion (dynamization), which promotes blood flow at the fracture or fusion site and accelerates the bone healing process. Additionally, external fixation devices may be used temporarily in complex fracture cases to stabilize the fracture prior to definitive treatment. In these situations, the device offers rapid fracture stabilization, which is crucial in lifesaving and limb-salvaging procedures.
The company offers most of its products in sterile packaged procedural kits, which fulfills the need of a streamlined and ready-to-use set of products, particularly in trauma applications or the military setting, where timing is crucial.
Examples of the company’s external fixation devices include the TrueLok, TL-HEX, TrueLok Evo, the Galaxy and Galaxy Gemini Fixation Systems, and the LRS Advanced Limb Reconstruction System.
Internal Fixation
Internal fixation devices consist of either long rods, commonly referred to as nails, or plates that are attached to the bone with the use of screws. Nails and plates come in various sizes, depending on the bone that requires treatment. A nail is inserted into the medullary canal of a fractured long bone of the human arm or leg (e.g., humerus, femur, or tibia). Alternatively, a plate is attached by screws to an area, such as a broken wrist, hip, or foot. Examples of the company's internal fixation devices include Chimaera, AHN, and the G-BEAM Fusion Beaming System.
The Fitbone Intramedullary Limb Lengthening System provides an internal option for limb lengthening of the femur and tibia, and together with the company's external fixation solutions, it provides Orthofix with the most complete limb reconstruction portfolio on the market. The portfolio was recently expanded with the release of the Fitbone Transport and Lengthening System, specifically developed for bone defect management applications. The company is continuing to invest in the Fitbone technology platform in order to offer surgeons more innovative solutions to meet both their needs to treat limb length discrepancies, and complex deformities.
In addition, the company also designs, manufactures, and distributes devices intended to treat congenital bone conditions, such as angular deformities (e.g., bowed legs in children), degenerative diseases, and conditions resulting from a previous trauma. An example of a product offered in this area is the eight-Plate Plus Guided Growth System.
Product Development
In 2024, the company incurred research and development expenses of $73.6 million.
Sales, Marketing and Distribution
The company has a broad sales network comprises direct sales representatives, sales agents, and distributors. This established sales network provides the company with a platform to introduce new products and expand sales of existing products. The company’s products are distributed in more than 60 countries worldwide.
Sales Network
The company's U.S. sales network is generally comprised of a mix of direct sales representatives and independent distributors, dependent upon each product category. An increasing number of these independent distributors sell products for more than one product category. The company's Bone Growth Therapies product category is largely supported by a hybrid distribution network of direct sales representatives and independent distributors, whereas its 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.
The company markets its Enabling Technologies portfolio through a direct sales force in the U.S., which collaborates with 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 its Spinal Implants and/or Biologics products.
In the U.S., the company typically consigns its Biologics products and consents or loans its 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, the company leaves sets with hospitals that are high-volume users for use in multiple procedures. These sets typically contain the instruments, including disposables, and implants required to complete a surgery. The company's Orthopedics business provides a wide array of single-use pack procedural solutions, alleviating the burden of instrument sets.
The company focuses on entering distribution relationships in territories with a high potential for growth, where its partner will carry its products exclusively, except with respect to clinical markets that its products do not address. The company believes these more exclusive relationships allow it to grow faster and in a more cost-effective manner in these territories over the long term. The company also plans to continue to invest in additional instrument sets, as well as marketing and education efforts to support the expansion of its independent sales agent footprint.
Outside the U.S., the company employs direct sales representatives in certain markets and also contracts with independent stocking distributors, who purchase its products directly from the company and independently sell them. In order to provide support to its independent sales network, the company has sales and product specialists who regularly visit independent distributors to provide training and product support.
Marketing and Product Education
The company markets and sells its products principally to physicians, hospitals, ASCs, integrated health delivery systems, and other purchasing organizations.
The company supports its sales force and sales expansion efforts through comprehensive and specialized training workshops for physicians and sales specialists, consistent with the AdvaMed Code of Ethics (‘AdvaMed Code’) and the MedTech Europe Code of Ethical Business Practice (‘MedTech Code’). Under the Orthofix Academy program, the company organizes regular multilingual teaching seminars in multiple locations and virtually. To this end, the company leverages the capacity of its hands-on cadaveric training laboratories located at its facilities in Lewisville, Texas, Carlsbad, California, and Wayne, Pennsylvania, to increase the number of training opportunities for surgeons and sales agents. In-person trainings are also held at the company's facility in Verona, Italy, and in various locations in Latin America. The company believes training and education will help surgeons become adept with its products and techniques, thereby improving outcomes for their patients. In recent years, thousands of surgeons from around the world have attended these in-person and virtual product education seminars, which have included a variety of lectures from specialists, as well as demonstrations and hands-on workshops.
The company also produces marketing and training materials, including materials outlining surgical procedures, for its customers, sales force, and distributors in a variety of languages, using printed, video, and multimedia formats. The company requires all of its sales force, both direct and independent, to undergo extensive product, policy, and compliance training to ensure adherence to its standards, policies, and applicable law.
Competition
The company’s Bone Growth Therapies product category competes principally with similar products marketed by Highridge Medical, Enovis, Bioventus, Theragen, and Xstim. The company’s 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. For Global Orthopedics devices, the company’s principal competitors include DePuy Synthes, Stryker, Smith & Nephew, Globus Medical, Enovis, Paragon 28, and OrthoPediatrics.
Manufacturing and Sources of Supply
The company generally designs, develops, assembles, tests, and packages its Bone Growth Therapies, Spinal Implants, Enabling Technologies, and Global Orthopedic products, and subcontracts the manufacturing of a substantial portion of the component parts and instruments.
The company’s products are currently manufactured and assembled in the U.S., Canada, Germany, Spain, China, and Italy. The company’s plants comply in all material respects with the requirements of the FDA and all relevant regulatory authorities outside the U.S.
Biologics
The company only sources its raw materials from tissue banks registered with the FDA and accredited by the AATB. The donors are screened, tested, and processed by the tissue banks in accordance with FDA and AATB requirements.
The company also partners with MTF Biologics to provide its customers with 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 the company's customers. This partnership allows the company to exclusively market the Virtuos Lyograft, Trinity ELITE, FiberFuse, and FiberFuse Strip, as well as certain other tissue forms.
Government Regulation
The company’s research, development, clinical programs, and its manufacturing and marketing operations, are subject to extensive regulation in the U.S. and other countries. Most notably, all of its products sold in the U.S. are subject to the Federal Food, Drug, and Cosmetic Act (the FDCA) and the Public Health Services Act as implemented and enforced by the FDA.
The company’s 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. the company’s 7D FLASH Navigation System is classified as Class II and certain accessories thereto are classified as Class I. the company’s 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.
The medical devices it develops, manufactures, distributes, and market are subject to rigorous regulation by the FDA and numerous other federal, state, and foreign governmental authorities.
Within the company’s Biologics product category, the company market’s 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. 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.
In addition to the company’s allograft solutions (HCT/Ps), the company markets and distributes additional demineralized bone putties, resorbable mesh with demineralized particulates, and synthetic putties and strips that are regulated by the FDA as medical devices. The company also provides ancillary technologies regulated by the FDA as medical devices that aid in the delivery of the company’s bone grafting options clinically. These products are sourced from third party manufacturers, which maintain an adequate inventory to avoid disruptions in product supply.
The company is American Association of Tissue Banks (AATB)-accredited and licensed or have permits for tissue banking in California, Florida, New York, Maryland, and other states that require specific licensing or registration.
The company and certain of its suppliers also are subject to announced and unannounced inspections by the FDA and European Notified Bodies to determine its compliance with the FDA’s QSR and other international regulations.
The company’s subsidiary, Orthofix US LLC, has been accredited by the Accreditation Commission for Health Care, Inc. (‘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.
The company’s sales and marketing practices are also subject to a number of U.S. laws regulating healthcare fraud and abuse, such as the federal Anti-Kickback Statute and the federal Physician Self-Referral Law (known as the ‘Stark Law’), the Civil False Claims Act, and the Health Insurance Portability and Accountability Act of 1996 (‘HIPAA’), as well as numerous state laws regulating healthcare and insurance. These laws are enforced by the OIG within the U.S. Department of Health and Human Services (‘HHS’), the U.S. DOJ, and other federal, state, and local agencies.
The Physician Payments Sunshine Provision of the Affordable Care Act (Section 6002) (the ‘Sunshine Act’), requires public disclosure to the U.S. government of payments to physicians and teaching hospitals, including in-kind transfers of value, such as gifts or meals. The Sunshine Act also provides penalties for non-compliance. The Sunshine Act requires that the company files an annual report on March 31st of each calendar year for the transfers of value incurred for the prior calendar year.
History
The company was founded in 1980. It was incorporated in 1987 in Curaçao as Orthofix International N.V. In 2018, the company completed a change in its jurisdiction of organization from Curaçao to the state of Delaware and changed its name to Orthofix Medical Inc.
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