Orthofix Medical Stock

Orthofix Medical Inc. (Orthofix) operates as a global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. The company’s products are distributed in approximately 68 countries worldwide through a combination of direct and indirect sales representatives and stocking distributors.

The company focuses on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics.

Segments

The company operates through Global Spine and Global Orthopedics segments.

Global Spine

Within the Global Spine segment, the company provides implantable medical devices, biologics, 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.

Global Spine 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 continued expansion of its presence in the U.S cervical disc replacement market through surgeon training, publication of clinical evidence to include long-term real world evidence, patient education, and sales channel support; a regular cadence of new product launches supporting its spine implant, biologics, and bone growth therapies portfolios; ongoing, global sales channel optimization; reinforcement of its 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 the spine portfolio; and attracting, developing, and retaining key talent.

Global Spine Principal Products

The Global Spine reporting segment is largely represented by three principal product categories, such as Bone Growth Therapies, Spinal Implants, and i Biologics.

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 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 its low intensity pulsed ultrasound (LIPU), 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 U.S. using distributors and direct sales representatives to provide its devices to healthcare providers and their patients.

Spinal Implants

Within the Spinal Implants product category, the company designs, develops, and markets a portfolio of motion preservation and fixation implant products used in surgical procedures 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, and out-patient hospitals.

Biologics

Within the Biologics product category, the company offers a portfolio of products and tissue forms that allow physicians to successfully treat a variety of spinal and orthopedic conditions. The company markets tissue forms provided by MTF Biologics (MTF) to spine care facilities and surgeons, primarily in the U.S., through a network of independent distributors and sales representatives. The company’s partnership with MTF allows it to exclusively market the Virtuos Lyograph, Trinity ELITE, FiberFuse Advanced, FiberFuse Strip, and certain other tissue forms for musculoskeletal defects to enhance bony fusion. In addition, the company markets regenerative non-tissue biologic solutions derived from synthetic materials. Opus BA, and Opus MG Set represent the company’s synthetic, biologic offering.

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.

Spinal Implants Products

M6-C Artificial Cervical Disc: A next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration; 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.

M6-L Artificial Lumbar Disc: A next-generation artificial 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.).

FIREBIRD / FIREBIRD NXG Spinal Fixation System: A system of rods, crossbars, and modular pedicle screws designed to be implanted during a posterior lumbar spine fusion procedure.

FORZA XP Expandable Spacer System: A titanium expandable spacer system for posterior lumbar interbody fusion (PLI”) and transforaminal lumbar interbody fusion (TLIF) procedures featuring a large graft window with the ability to pack post expansion in situ.

FORZA PEEK / Titanium Composite (PTC) Spacer System: A posterior lumbar interbody with 3D printed porous titanium end plates that may promote bone ingrowth and a polyetheretherketones (PEEK) core to maintain imaging characteristics.

FORZA Spacer System: PEEK interbody devices for PLIF and TLIF procedures.

FORZA Ti Spacer System: Fully 3D printed titanium devices for PLIF and TLIF procedures.

CENTURION Posterior Occipital Cervico-Thoracic (POCT) System: A multiple component system consists of a variety of non-sterile, single use components made of titanium alloy or cobalt chrome that allow the surgeon to build a spinal implant construct.

PHOENIX Minimally Invasive Spinal Fixation System: A multi-axial extended reduction screw body used with the Firebird Spinal Fixation System designed to be implanted during a posterior thoracolumbar spine fusion procedure.

CONSTRUX Mini PTC Spacer System: An anterior cervical interbody with 3D printed porous titanium end plates that may promote bone ingrowth and a PEEK core to maintain imaging characteristics.

CONSTRUX Mini Ti Spacer System: Fully 3D printed titanium anterior cervical interbody spacer system.

CETRA Anterior Cervical Plate System: An anterior cervical plate system offering a low profile plate with an intuitive locking mechanism, large graft windows, a high degree of screw angulation, and simplified instrumentation.

JANUS Midline Fixation Screw: An addition to the Firebird Spinal Fixation System designed to achieve more cortical bone purchase in the medial to lateral trajectory, when compared to traditional pedicle screws, and that provides surgeons with the option of a midline approach.

LONESTAR Cervical Stand Alone: A stand-alone spacer system designed to provide the biomechanical strength to a traditional or minimal invasive anterior cervical discectomy and fusion procedure with less disruption of patient anatomy and to preserve the anatomical profile.

PILLAR SA PTC PEEK Spacer System: A standalone anterior lumbar interbody fusion (ALIF) interbody with 3D printed porous titanium end plates that may promote bone ingrowth and a PEEK core to maintain imaging characteristics.

SKYHAWK Lateral Interbody Fusion System and Lateral Plate System: Provides a complete solution for the surgeon to perform a lateral lumbar interbody fusion, an approach to spinal fusion in which the surgeon accesses the intervertebral disc space using a surgical approach from the patient’s side that disturbs fewer structures and tissues.

FIREBIRD SI: A minimally invasive screw system that is intended for fixation of sacroiliac joint disruptions in skeletally mature patients.

Virtuos Lyograft: A first-of-its-kind, shelf-stable and complete autograft substitute for spine and orthopedic procedures provided in a room-temperature, ready-to-use, moldable form.

Trinity ELITE: A fully moldable allograft with viable cells used during surgery that is designed to aid in the success of a spinal fusion or bone fusion procedure.

FiberFuse Advanced: An allograft consists of a mixture of cancellous bone and demineralized cortical bone fibers that creates a natural scaffold for revascularization, cellular ingrowth, and new bone formation.

FiberFuse Strip: A preformed allograft that consists of mineralized cancellous bone and demineralized cortical fibers, providing an ideal matrix for bone healing.

O-Genesis Graft Delivery: A bone graft delivery system, which is provided in a sterile, single-use form.

Opus Mg Set: An injectable, moldable, and biocompatible bone void filler that will harden in-situ at the defect site.

Opus BA: A synthetic osteoconductive scaffold that is compression resistant, fully resorbable, and easily customizable for a range of clinical applications.

Legacy Demineralized Bone Matrix (DBM): A ready-to-use, flowable DBM putty.

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 use a 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 uses proprietary technology and a wavelength to generate a PEMF signal. The U.S. Food and Drug Administration (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.

The company’s 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 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 use 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 company’s 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 to the fracture site.

Spinal Implants — Motion Preservation Solutions

The company’s M6-C cervical and M6-L lumbar artificial discs are used to treat patients suffering from degenerative disc disease of the spine. The M6 discs are the only FDA-approved artificial discs that mimic the anatomic structure of a natural disc by incorporating an artificial viscoelastic nucleus and fiber annulus into their design. Like a natural disc, this unique construct allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements. Both discs have European Commission CE mark approval and in February 2019, the company received FDA approval of the M6-C artificial cervical disc to treat patients with a single-level cervical disc degeneration. The company released the M6-C artificial cervical disc in the U.S. in 2019 through a controlled market launch accompanied by an extensive training and education curriculum for surgeons. The M6-C disc has become the company’s leading spinal implant device and has contributed significantly to its growth in recent years. In addition, the company has initiated a U.S. 2-level investigational device exemption (IDE) study for the M6-C artificial cervical disc, which is enrolling.

Spinal Implants — Spinal Fixation Solutions

The company provides a wide array of implants designed for use primarily in cervical, thoracic, and lumbar fusion surgeries. These implants are made of either metal or a thermoplastic compound called PEEK. The majority of the implants that the company offers are made of titanium metal. The Firebird Spinal Fixation System, the Phoenix Minimally Invasive Spinal Fixation System, and the Centurion POCT Systems are sets of rods, cross connectors, and screws that are implanted during posterior fusion procedures. The Firebird Modular and pre-assembled Spinal Fixation Systems are designed to be used in either open or minimally-invasive posterior lumbar fusion procedures. To complement its plates, rods, and screw fixation options, the company offers an entire portfolio of cervical and thoracolumbar Titanium and PEEK interbody devices within its Pillar and Forza product lines. The company has recently introduced two, new 3D printed interbody solutions, Construx Mini Ti for cervical and Forza Ti for posterior lumbar implantation. This interbody portfolio includes two stand-alone devices, Lonestar and Pillar SA, as well as the Construx Mini PTC system, a novel titanium composite spacer, which offers a superior alternative to other plasma spray coated options available on the market. The company also offers specialty plates and screws that are used in less common procedures.

Biologics — Regenerative Solutions

The premium biologics tissues the company markets include the Virtuos Lyograft and Trinity ELITE tissue forms, which are cortico-cancellous allografts that retain the inherent growth factors and viable cells found in bone. They are used during surgery in the treatment of musculoskeletal defects for bone reconstruction and repair. These allografts are intended to offer a viable alternative to an autograft procedure, as harvesting autograft has been shown to add risk of an additional surgical procedure and related patient discomfort in conjunction with a repair surgery. Virtuos Lyograft is particularly unique in that it is a first-of-its-kind, shelf-stable and complete autograft substitute for spine and orthopedic procedures provided in a room-temperature, ready-to-use, moldable form.

The FiberFuse Advanced tissue is a tissue form with handling characteristics analogous to the Trinity ELITE product without compromising bone content. It provides an advanced demineralized bone offering that leverages fiber technology with the advantages of ingrowth that cancellous bone provides and expands the offering to address a broader scope of surgical applications. FiberFuse Strip is a preformed allograft form of FiberFuse Advanced that consists of mineralized cancellous bone and demineralized cortical fibers, providing an ideal matrix for bone healing. Legacy DBM is a ready-to-use, flowable, demineralized bone putty and provides a option without compromising clinical experience.

The company receives marketing fees through its collaboration with MTF for the Virtuos, Trinity ELITE, FiberFuse Advanced, FiberFuse Strip, Legacy DBM 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. The company has exclusive worldwide rights to market the Virtuos and Trinity ELITE and exclusive rights to market the FiberFuse Advanced and FiberFuse Strip tissues in the U.S.

Regarding synthetic, biologic solutions, the company offers Opus BA and Opus Mg Set. Opus BA is a synthetic bioactive solution that is easily hydrated and flexible. A carefully selected trifecta of components creates an ideal environment for bone growth building on the earlier generations of synthetic bone grafts. Opus Mg Set is an injectable, moldable, and biocompatible bone void filler that will harden in-situ at the defect site.

As of December 31, 2022, the company’s Biologics products are offered primarily in the U.S. market due in part to restrictions on providing U.S. human donor tissue in other countries.

Global Spine Future Product Applications

The company remains very active with multiple internal developments to support future, new technology commercialization efforts. These new technologies will apply to both the cervical and thoracolumbar spinal anatomy. In addition, the company remains active in evaluating external licensing and acquisition opportunities to add implant, biologics, and other emerging technologies to its spine portfolio. The company expects that the contribution of new, internally developed technologies and undefined external acquisitions will be the primary driver of future growth.

Regarding the company’s Bone Growth Therapy business, it has 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 to identify the mechanisms of action of its PEMF signals on bone, cartilage, meniscus, nerve, and 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, 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. This collection of pre-clinical data, along with additional clinical data, could represent new clinical indication opportunities for its regenerative stimulation solutions. In addition, the company has initiated a U.S. 2-Level IDE study for the M6-C artificial cervical disc.

Global Orthopedics

The Global Orthopedics reporting segment offers products and solutions for limb deformity correction and complex limb reconstruction with a focus on use in trauma, pediatrics, and foot and ankle procedures. 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 is to continue to offer pioneering limb reconstruction and deformity correction procedural solutions that address the entire patient treatment pathway.

The key elements of the company’s strategy are to expand its position as the worldwide leader in complex deformity and limb reconstruction, including both internal and external solutions, through a patient-centric approach and digital treatment journey; promote the advantages of its expansive pediatric product portfolio and support tools; leverage its cross-product OrthoNext digital platform, a uniquely developed pre and post planning digital platform, 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 their chosen surgical plan success; expand its foot and ankle portfolio by building on its historical position as a company highly focused on addressing complex and challenging conditions and remaining at the forefront of innovation in helping surgeons and patients alike in the management of Charcot foot and ankle; promote and invest in its Fitbone intermedullary limb lengthening platform, which together with its external fixation products, offers surgeons internal and external solutions for limb lengthening and deformity correction; within the orthopedic trauma segment, continue to focus on open and complex fracture management; collaborate with physicians and healthcare partners to improve patients’ lives through technology, digital transformation, clinical evidence, and its industry-leading medical education programs, such as 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 and complex deformity correction technologies. The company provides innovative and minimally invasive extremity solutions to help surgeons improve their patients' quality of life, which are designed to address the lifelong bone and joint health needs of patients of all ages. In addition, the company’s well-rounded product lines offer internal and external fixation solutions for pediatrics, limb reconstruction, trauma, and foot and ankle specialties.

The company’s fracture repair solutions comprise a wide range of devices designed for specific anatomical areas. The philosophy underlying these devices is to provide adequate stability and to allow for early functional recovery, thereby improving patients’ quality of life. The company’s goal is to offer devices that enable a simple, standardized approach for reproducible results.

The company’s trauma products consist of a comprehensive portfolio of ready-to-use, sterile, dedicated implant kits designed for a wide range of anatomical sites.

TrueLok: A surgeon-designed, lightweight external fixation system for trauma, limb lengthening, 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 trauma and deformity correction with associated software, 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: A modular circular external fixation system that features both radiolucent rings and struts to enable clear radiographic visualization to allow physicians to better assess bone anatomy both during surgery and 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.

Pediatric Portfolio: The company’s pediatric solutions include a range of products and resources dedicated to pediatrics and young adults with bone fractures and deformities. With its 360° approach to the patient journey, the company provide dedicated tools to treat all stages of the healing process: collaterals, educational games, software applications, and patient apps for post-operative management.

The company’s pediatric solutions portfolio includes, among the others a complete line of nailing systems for trauma and limb reconstruction, including its elastic nail, MJ-FLEX, and its rigid intramedullary nail for adolescents, Agile Nail; the Galaxy Fixation Pediatric System; the eight-Plate Guided Growth System (eight-Plate) and the eight-Plate Guided Growth System+ (eight-Plate Plus); and the JuniOrtho Plating System.

Galaxy Fixation System: A pin-to-bar system for temporary and definitive fracture fixation, in the upper and lower limbs. 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 more large 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 arthroplasty.

External Fixators: External fixation, including the company’s limb-lengthening systems, ProCallus, XCaliber, Pennig, Radiolucent Wrist Fixators, and Calcaneal Fixator.

eight-Plate and eight-Plate Plus: The first and still market-leading system for gradual correction of the growth plate in pediatric patients.

LRS advanced Limb Reconstruction System: An external fixation solution for limb lengthening and corrections of deformity, which uses callus distraction to lengthen bone in a variety of procedures, including monofocal lengthening and corrections of deformity; its multifocal procedures include bone transport, simultaneous compression and distraction at different sites, bifocal lengthening, and correction of deformities with shortening.

OrthoNext Digital Platform: A digital platform software developed specifically for use with the JuniOrtho Plating System and Fitbone Intramedullary Limb Lengthening System, which enables the surgeon to accurately plan the deformity correction and osteotomy position as well as visualize the implant in relation to the anatomy.

The company provides internal and external fixation solutions for extremity repair and deformity correction, both for adults and children. The company’s fracture repair products consist of fixation devices designed to stabilize a broken bone until it can heal. With these devices, the company can treat simple and complex fracture patterns, along with achieving deformity corrections.

External Fixation

External fixation devices are used to stabilize fractures and offer an ideal treatment for complex fractures, fractures near the joints, and in patients with known risk factors or co-morbidities. The treatment is minimally invasive and allows external manipulation of the bone to obtain and maintain final bone alignment (reduction). The bone is fixed in this way until healing occurs. External fixation allows small degrees of micromotion (dynamization), which promotes blood flow at the fracture site, and accelerates the bone healing process. External fixation devices may also be used temporarily in complex trauma cases to stabilize the fracture prior to treating it definitively. In these situations, the device offers rapid fracture stabilization, which is important in life-saving, as well as limb salvage procedures.

The company offers most of its products in sterile packaging, which fulfills the need of a streamlined and ready-to-use set of products, particularly in trauma applications 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.

Acquired in March 2020, the FITBONE Intramedullary Limb Lengthening System provides an internal option for limb lengthening of the femur and tibia and provides Orthofix with the most complete limb reconstruction portfolio on the market. The company is continuing to invest in the FITBONE technology platform in order to offer surgeons more solutions for deformity correction.

In addition to treating bone fractures, the company 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.

SeaSpine

SeaSpine's business focuses on the design, development, and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. The company has a comprehensive portfolio of biologics and spinal implant solutions, as well as a surgical navigation system, to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures in the lumbar, thoracic, and cervical spine. This broad combined portfolio is essential to meet the complete solution requirements of these surgeons.

SeaSpine has historically reported revenue in two product categories: Biologics and Spinal Implants and Enabling Technologies. The company’s Biologics products consist of a broad range of advanced and traditional bone graft substitutes designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. The company’s Spinal Implants and Enabling Technologies portfolio consists of an extensive line of products and image-guided surgical solutions to facilitate spinal fusion in degenerative, minimally invasive surgery (MIS), and complex spinal deformity procedures. Expertise in biologic sciences and spinal implants, software and advanced optics product development allows SeaSpine to offer surgeon customers a differentiated portfolio and a complete solution to meet their patients' fusion requirements.

SeaSpine Strategy

The key elements of the company’s strategy are to continue to increase its research and development activities to bring new products and techniques to market; continue to increase the quality, size, exclusivity, and geographic breadth of its network of independent sales agents in the U.S.; iInvest in the further development of its pre-clinical and clinical programs designed to generate peer-reviewed scientific evidence in support of its products; and continue to pursue strategic alliances and acquisition opportunities to enhance its product offerings.

SeaSpine Principal Products

SeaSpine is largely represented by two principal product categories, Biologics and Spinal Implants and Enabling Technologies.

Biologics

The company’s Biologics products are used in orthopedic and dental procedures and consist of a broad range of bone graft substitutes intended to address the key elements of bone regeneration. Bone graft substitutes are composed of natural biologic proteins and synthetic materials. They are designed to reduce the amount of autologous bone grafts needed for spinal fusion procedures. Bone graft substitutes, depending on their design, can be used entirely in place of the patient’s own bone tissue, called an autograft, or by extending the volume of bone graft material from the patient by combining it with the bone graft substitute. The company’s Biologics portfolio includes fibers-based and particulate DBM, collagen ceramic matrices, demineralized cancellous allograft bone and synthetic bone void fillers. The company offers its Biologics products in the form of fibers, putties, pastes, strips and DBM in a resorbable mesh for a range of surgical applications.

Spinal Implants and Enabling Technologies

The company’s Spinal Implants and Enabling Technology portfolio consists of an extensive line of products for spinal decompression, alignment, stabilization and image-guided surgical solutions, as well as a surgical navigation system designed 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 and cervical regions of the spine. The company’s products are increasingly focused on restoring adequate spinal balance and profile in the sagittal (front to back) plane, which is widely recognized as an important factor to improve the quality of life in patients undergoing surgery for spinal degeneration or deformity.

Biologics Products

Accell Bone Matrix: 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, both fibers and particulate forms, provides a biphasic release of growth factors to promote healing.

OsteoStrand Plus / OsteoStrand: 100% Demineralized Bone Fibers product lines designed to facilitate and aid in fusion by maximizing osteoinductive content while providing an improved conductive matrix; OsteoStrand Plus incorporates the company’s proprietary Accell Bone Matrix.

Evo3/Evo3c DBM Putties: Advanced DBM putties that combine traditional DBMs with Accell, with and without cancellous chips.

OsteoTorrent/OsteoTorrent C: Advanced DBM putties that combine Accell Bone Matrix and particulate DBM, with and without cancellous chips; packaged and sterilized in a dry state to improve product’s osteoinductive potential, shelf-life stability, and shelf-life.

OsteoBallast and Ballast DBM in Resorbable Mesh: A resorbable mesh containing 100% DBM without a carrier, designed to simplify graft placement and help prevent graft migration while maximizing DBM content.

OsteoStrux and Mozaik: Blend of collagen and ß-TCP to create an osteoconductive material for bone regeneration; available in both putty and strip configurations.

Spinal Implants and Enabling Technologies Products

Reef-TO, Reef-TA and Reef-TH interbody devices: PEEK interbody devices featuring NanoMetalene surface technology for PLIF and TLIF procedures.

Vu a·POD Prime NanoMetalene and Reef-A interbody devices: PEEK interbody devices featuring NanoMetalene surface technology for ALIF procedures.

Regatta NanoMetalene Lateral System: A comprehensive lateral lumbar interbody system that can be used to fuse the spine through a lateral approach

Cambria NanoMetalene interbody device: Interbody device used to fuse the cervical spine through an anterior approach.

Shoreline Anterior Cervical Standalone System, featuring the NanoMetalene with Reef Topography: A modular plate and interbody device designed to maximize intraoperative flexibility to address a wide range of anatomy, surgical situations or bone in anterior cervical fusions.

Waveform: 3D-printed interbody fusion devices for anterior cervical, transforaminal lumbar, lateral lumbar and articulating transforaminal lumbar interbody fusion.

Explorer TO Expandable Interbody Device System: An expandable interbody device system with complementary lordotic and parallel expanding implant options.

NorthStar OCT Posterior Cervical Fixation System: Spinal fixation system with novel instrumentation and anatomically designed implants to provide a safe and effective solution designed to improve surgical flow when navigating through complex cervical procedures.

Admiral Anterior Cervical Plating System (ACP): A comprehensive and complete anterior cervical plating system designed to strike the optimal balance between strength, profile, and construct rigidity.

Mariner Posterior Fixation System: Pedicle screw system for open and MIS procedures and adult deformity procedures featuring modular threaded 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 lumbar fixation.

NewPort MIS System: MIS system with extended tabs for a small incision profile that offers two rod delivery options for both mini-open and percutaneous approaches.

Mariner MIS Posterior Fixation System: MIS system with low-profile, robust towers for rod introduction and reduction, as well as ultra-tough modular extended tab heads, capable of providing powerful instrumented compression and distraction of the spine.

Daytona Deformity System: Complex spinal deformity procedure system that uses extended tab uniplanar and polyaxial screws with multiple rod options and intuitive instrumentation to create a versatile system adaptable to surgeon preference.

Daytona Small Stature System: System designed to address standard to complex deformity cases in smaller-sized patients who need a lower profile construct due to anatomy constraints.

Mariner Outrigger Revision System: An adjunct to the Mariner Posterior Fixation System designed to effectively revise and extend previous fusions.

FLASH Navigation with 7D Technology (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.

FLASH Navigation with 7D Technology (Percutaneous): A valuable enhancement to the FLASH Navigation platform to address percutaneous spinal procedures; the camera-based technology coupled with 7D Machine Vision algorithms maintain the same fast, accurate, and efficient surgical workflow as the Spine platform, while also providing an imaging agnostic solution to percutaneous posterior spine surgery.

FLASH Navigation with 7D Technology (Cranial): A module on the FLASH Navigation platform 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.x

Enabling Technologies

The company’s machine vision FLASH navigation platform is used in a variety of posterior spinal procedures, including degenerative, deformity, tumor, trauma, and revision surgery. The platform can be utilized in MIS/Percutaneous, Mini-Open, or Open techniques. The technology also offers a comprehensive cranial platform for use in cranial neurosurgery.

The company’s innovative FLASH Navigation System with 7D Technology 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. 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.

The company’s Spine Module is its leading product in the FLASH Navigation Portfolio with over 104 installations globally. In 2022, the company further enhanced the Spine Module by adding preplanning features, as well as fully integrating the Mariner Posterior Fixation System, Mariner MIS Posterior Fixation System, and the Northstar OCT Posterior Cervical Fixation System into the platform with both hardware and software enhancements. The company also released its commercial FLASH Percutaneous Spine Module in 2022 for the navigation of minimally invasive spinal procedures. This application, accompanied by new instrumentation, addresses an important part of the spine navigation market to round out the FLASH Navigation Platform and is a valuable enhancement for both hospitals and ambulatory surgery centers. Further enhancements and new features to the Spine Module and Percutaneous Module are in development and are expected to launch in 2023.

In addition to these new products focused on spine, the FLASH Navigation Portfolio consists of the company’s Cranial Module for use in cranial surgeries. The technology uses a completely contactless workflow, acquiring 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. New developments are also underway and expected to launch in 2023 which leverage the 7D Technology to further expand cranial applications and enter the neurocritical care market with the launch of FLASH EVD ("Extra Ventricular Drainage"), a mobile bed-side navigational system designed for fast and reliable EVD placement.

SeaSpine Future Product Applications and Development

The company continues to aggressively develop differentiated new products that it will allow the entrance into new markets and be even more competitive in markets in which it is underrepresented.

The company expects to launch the next iteration of the FLASH Percutaneous Module and FLASH Spine Module with additional enhancements to its preplanning software, as well as developing the framework for navigating interbody procedures. The company also plans to launch FLASH EVD, a small mobile bed-side navigational system designed for fast and reliable EVD placement that will expand its total addressable market with this first entry into the neurocritical care market.

Research and Development

In 2022, the company incurred research and development expenses of $49.1 million.

Sales Network

The company’s the U.S. sales network is generally consisted 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. that works together with its 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 spine and/or biologics products.

In the U.S., the company typically consigns its Biologics products and consign or loan 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 or leave them 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 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 also plans to continue to invest in additional instrument sets and 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 contract with independent stocking distributors, who purchase its products directly from it 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, ambulatory surgery centers, 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). The company organizes regular multilingual teaching seminars in multiple locations and also virtually. To this end, the company leverages the capacity of its hands-on cadaveric training laboratories located at its Lewisville, Texas, Carlsbad, California, and Wayne, Pennsylvania facilities to increase the number of training opportunities for surgeons and sales agents. In-person trainings are also held at its facility in Verona, Italy, and in various locations in Latin America. Training and education will help surgeons become adept with the company’s 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, 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 Zimmer Biomet, DJO Global, and Bioventus. 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, Medtronic, NuVasive, Stryker, Surgalign, XTANT Medical, ZimVie and various smaller public and private companies. For Global Orthopedics devices, the company’s principal competitors include DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew, and OrthoPediatrics.

Government Regulation

Most notably, all of the company’s products sold in the U.S. are subject to the Federal Food, Drug, and Cosmetic Act; and the Public Health Services Act as implemented and enforced by the FDA.

Unless an exemption applies, each medical device that the company commercially distributes in the U.S. is covered by premarket notification (510(k)) clearance, letter to file, approval of a premarket approval application (PMA), or some other approval from the FDA.

The company’s Bone Growth Therapies products and the M6-C artificial cervical disc are classified as class III and has been approved for commercial distribution in the U.S. through the PMA process.

The company and certain of its suppliers are also subject to announced and unannounced inspections by the FDA and European Notified Bodies to determine its compliance with the FDA’s Quality System Regulation 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).

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 Office of Inspector General within the U.S. Department of Health and Human Services (HHS), the U.S. Department of Justice, and other federal, state, and local agencies.

The Physician Payments Sunshine Provision of the Affordable Care Act (Section 6002) requires that the company files an annual report on March 31st of a calendar year for the transfers of value incurred for the prior calendar year.

History

The company was founded in 1987. It was incorporated in 2018 under the laws of the Netherlands Antilles. The company was formerly known as Orthofix International N.V. and changed its name to Orthofix Medical Inc. in 2018.