SeaSpine Holdings Corporation operates as a global medical technology company.
The company 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 orthobiologics and spinal implant solutions 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. The...
SeaSpine Holdings Corporation operates as a global medical technology company.
The company 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 orthobiologics and spinal implant solutions 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. The company’s orthobiologics 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 implant portfolio consists of an extensive line of products to facilitate spinal fusion in degenerative, minimally invasive surgery (MIS), and complex spinal deformity procedures. Expertise in both orthobiologic sciences and spinal implant product development allows the company to offer surgeon customers a differentiated portfolio and a complete solution to meet their patients' fusion requirements.
Products
The company offers a portfolio of orthobiologics and spinal implant products for the treatment of patients suffering from spinal and other orthopedic disorders.
Orthobiologics
The company’s orthobiologics 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 composed of natural biologic proteins and synthetic materials 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 orthobiologics portfolio includes fibers-based and particulate demineralized bone matrix (DBM), collagen ceramic matrices, demineralized cancellous allograft bone and synthetic bone void fillers. The company offers its orthobiologics products in the form of fibers, putties, pastes, strips and DBM in a resorbable mesh for a range of surgical applications.
Demineralized Bone Matrix and Accell
The company’s first-generation DBM formulations combined particulate-demineralized bone matrix with an inert carrier engineered for easy graft handling and graft containment. The carrier is a biocompatible synthetic polymer with an advantageous property that allows the product to remain moldable at room temperature, but becomes more viscous at body temperature once implanted, which the company calls reverse-phase. Subsequently, the company developed a proprietary process to transform particulate-based DBM into a dispersed form to enhance the performance of the graft material. The result of this process was a DBM product that the company calls Accell Bone Matrix.
Accell Bone Matrix is an open structured, dispersed form of DBM, which increases the bioavailability of bone proteins at an earlier time in the healing cascade. Standard particulate DBM is dense and therefore the bone proteins release more slowly and in a sustained manner over time. The properties of Accell Bone Matrix and DBM are both desirable, which is why the company’s advanced DBM products include both components to harness both the early and sustained release of bone proteins. The company’s Accell Evo3 and OsteoSurge 300 DBM products provide an optimized formulation of Accell Bone Matrix, particulate-based DBM, and the company’s reverse-phase carrier. These products have a handling property for bone grafting procedures and contain three times the amount of the Accell Bone Matrix compared to earlier products. Providing both the early-stage and late-stage accessibility of osteoinductive bone proteins provided by a composite of Accell Bone Matrix and the particulate-based demineralized matrix differentiates the company’s product compared to competitive DBM products.
The company’s OsteoStrand and Strand Demineralized Bone Fibers product lines, as well as its OsteoStrand Plus and Strand Plus product lines, which incorporate the company’s proprietary Accell Bone Matrix, provide 100% demineralized bone fibers designed to facilitate and aid in fusion by maximizing osteoinductive content while providing an improved conductive matrix.
The company’s OsteoBallast and Ballast Demineralized Bone Matrix in Resorbable Mesh product lines are designed to facilitate and aid in fusion. These products, which consist of a resorbable mesh containing 100% DBM without a carrier, are designed to simplify graft placement and help prevent graft migration while maximizing DBM content. OsteoBallast is designed to provide surgeons with a simple means for delivering bone graft in posterior spine surgery that contours to the local anatomy while maintaining shape and volume under compression.
Collagen Ceramic Matrix Technologies
The company’s collagen ceramic matrix technology leverages a history of regenerative technology and collagen engineering. The company’s leading products in this category are marketed as IsoTis Mozaik and OsteoStrux, and are engineered to provide a porous scaffold architecture and osteoconductivity. These products also support osteogenesis, as they are indicated for use with bone marrow aspirate, which contains osteogenic cells. These products are composed of highly purified beta-tricalcium phosphate granules, which provide mineral content to foster bone formation during the healing process in a framework of type-1 collagen that provides a scaffold for bone cell migration. These products are engineered with a resorption profile consistent with the rate of natural bone formation.
Other Bone Graft Substitutes
The company’s other bone graft substitute products consist of allograft cancellous bone scaffolds and synthetic bone void fillers.
Spinal Implants
The company’s spinal implant portfolio consists of an extensive line of products for spinal decompression, alignment, and stabilization. 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 focus 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.
Degenerative
The company’s degenerative products include systems used in open and minimally invasive surgery (MIS) procedures. Open procedures are still the most common surgical approach and involve a midline incision followed by retraction of the skin and soft tissues. The company offers an extensive portfolio of degenerative products designed for use in both thoracolumbar and cervical spine cases.
The company’s line of composite polyetheretherketone (PEEK) interbody devices featuring NanoMetalene surface technology with Reef Topography with various footprint and lordotic options, is designed to maintain spine alignment and appropriate spacing while allowing bone to grow between the vertebrae to achieve bone fusion. The company’s Reef-TO, Reef-TA and Reef-TH interbody devices for transforaminal lumbar interbody fusion procedures can be used to fuse the lumbar spine through a posterior approach that starts off to one side of the patient’s back.
The company’s Vu a·POD Prime NanoMetalene and Reef-A interbody devices for anterior lumbar interbody fusion procedures can be used to fuse the spine through an anterior approach. The company’s Regatta NanoMetalene Lateral System is a comprehensive lateral lumbar interbody system that can be used to fuse the spine through a lateral approach. The company’s Cambria NanoMetalene interbody device can be used to fuse the cervical spine through an anterior approach. The company’s Shoreline Anterior Cervical Standalone System, featuring the NanoMetalene with Reef Topography, is 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.
The company launched anterior cervical and transforaminal lumbar interbody fusion interbody 3D-printed devices under its Waveform brand in 2020. The company plans on launching three additional devices covering the anterior lumbar interbody fusion, lateral lumbar interbody fusion and articulating transforaminal lumbar interbody fusion interbody device in 2021 to expand the product line.
The company launched the next generation of its Explorer TO expandable interbody device system with complementary lordotic and parallel expanding implant options in 2020 and enhancements to that system are in development.
The company offers a comprehensive portfolio of spinal fixation products for the cervical, thoracic and lumbar regions of the spine, consisting of rods, screws, plates and instrumentation to facilitate spinal decompression and fusion. The company’s Mariner Posterior Fixation System is a pedicle screw system for open and MIS 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. The company also offers a variety of screw and plating systems, such as its Cabo ACP Anterior Cervical Plating System, which combine large graft viewing windows and a visual confirmation locking system for cervical fixation.
Minimally Invasive Surgery
The company’s surgeon customers utilize its iPassage MIS Retractors, NewPort Tube Retractors, and new pedicle screw-based Mariner MIS Retractors to perform MIS fusions and decompression procedures, a surgical technique used to alleviate pain caused from compression on the spinal cord or the nerves that emanate from it. During the procedure, the surgeon makes a small incision and inserts the retractor through the skin and soft tissues down to the spinal column, creating a tunnel to the spine. The retractor is kept in place to hold the muscles open throughout the procedure. Through this tunnel, the surgeon accesses the spine using small instruments and inserts implants necessary for fusion, such as the screws and rods of the company’s Mariner MIS Posterior Fixation System and NewPort MIS solutions. The Mariner MIS Posterior Fixation System features 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. The company’s NewPort MIS product has extended tabs for a small incision profile and offers two rod delivery options for both mini-open and percutaneous approaches. The company’s MIS portfolio also includes a comprehensive set of decompression instruments, static and expandable interbody devices, and screw systems designed to facilitate access to the treatment area while minimizing anatomical disruption.
Complex Spinal Deformity
The company’s spinal implant products are used in complex spinal deformity procedures involving multiple spine segments, challenging anatomy, tumors, traumatic injury and revision of previous fusion surgeries. The company defines deformity as any variation in the natural curvature of the spine, the most common of which is scoliosis, an abnormal lateral curvature of the spine. The company offers several technologies designed to address the needs of its surgeon customers who perform complex deformity procedures and the various derotation techniques they use to correct spine curvature. For example, the company’s Daytona Deformity System uses extended tab uniplanar and polyaxial screws with multiple rod options and intuitive instrumentation to create a versatile system adaptable to surgeon preference.
The company’s Daytona Small Stature System, which has an adolescent idiopathic scoliosis indication, is designed to address standard to complex deformity cases in smaller-sized patients who need a lower profile construct due to anatomy constraints. The company provides its systems in multiple configurations and materials to address patient requirements, including titanium alloy and cobalt chrome alloy rod options, as well as multiple rod diameters. Offering products with varying rod diameter and materials provides the surgeon different rod stiffness to treat individual patients.
The company offers both implant- and instrument-based reduction capabilities with its extended tab and locking cap products, as well as the company’s uniplanar and D-planar screws and rapid sequential reduction towers. The Mariner Outrigger Revision System is an adjunct to the Mariner Posterior Fixation System designed to effectively revise and extend previous fusions. The company’s complex spinal implant portfolio allows surgeons to combine various product lines and approaches, offering several treatment options for the most difficult cases. In 2021, the company plans to continue to extend the Mariner modular platform to address complex spine adult deformity pathologies.
Product Pipeline
During 2021, the company expects to launch a new modular anterior lumbar interbody fusion system with multiple interbody and fixation options, a new anterior cervical plating system, a new posterior cervical and occipital fixation system, a new cervical and thoracolumbar modular corpectomy system, and an adult deformity posterior fixation system.
Strategy
The company’s strategy includes research and development to bring new products and techniques to market; commercial infrastructure to further penetrate the U.S. orthobiologics and spinal implant markets and increase its focus in international markets where the company has a presence; pre-clinical and post-market clinical study programs to generate data; and opportunities to enhance its product offering through strategic alliances and acquisitions.
Sales and Distribution
The company markets and sells its products in the United States and in approximately 30 countries worldwide. Its United States sales organization consists of regional and territory business managers who oversee a broad network of independent orthobiologics and spinal implant sales agents that receive commissions from the company based on sales they generate. The company’s international sales organization consists of a sales management team that oversees a network of independent orthobiologics and spinal implant stocking distributors that purchase its products directly from the company and independently sell them.
In international markets, the company predominantly sells complete instrument and implant sets to independent stocking distributors, who consign or loan these sets to surgeons. The company maintains sales and marketing personnel in France to manage and support its stocking distributors in Europe; and uses third-party distribution facilities in Belgium and the Netherlands to support European distribution efforts.
Internationally, the company intends to continue to focus its sales and marketing efforts on expanding and strengthening its presence in those markets where the company has relationships with stocking distributors and to selectively expand into new markets.
Suppliers
The company entered into a new supply agreement with PcoMed, LLC (PcoMed) in March 2021, which terminates in January 2024. PcoMed serves as the company’s sole supplier for the technology.
Intellectual Property
The company licensed three U.S. patents related to certain of its pedicle screw systems.
The company’s material registered and unregistered trademarks include Accell, Accell Connexus, Accell Evo3, Accell Evo3c, Accell TBM, Accell Total Bone Matrix, Atoll, Ballast, Capistrano, Coral, Current, Daytona, DynaGraft II, Explorer, Fusion Engineered, Hollywood, IsoTis, IsoTis OrthoBiologics, Malibu, Mariner, Meridian, NanoMetalene, NewPort, NorthStar, NorthStar OCT, OrthoBlast II, OsteoBallast, OsteoCurrent, OsteoStrand, OsteoStrux, OsteoSurge 100 (or 300), Outrigger, RAPID, Reef, Regatta, SeaSpine, Shoreline, Shoreline RT, Sierra, SkipJack, SkipJack Expandable Interbody, Sonoma, Strand, Trident-C, Trident-L, TruProfile, Vu a•POD, Vu a•POD Prime, and WayFinder.
Regulation
The company is subject to extensive regulation by the U.S. Food and Drug Administration (FDA), other federal governmental agencies, and in some jurisdictions, by state and foreign governmental agencies.
The FDA requires, as a condition to marketing a medical device in the United States, and as applicable based on product type and classification, which the company secures a Premarket Notification clearance pursuant to Section 510(k) of the United States Federal Food, Drug, and Cosmetic Act (FDCA) or an approved premarket approval (PMA) application (or PMA supplement).
To perform clinical trials for significant risk devices in the United States on an unapproved product, the company is required to obtain an Investigational Device Exemption from the FDA.
The company’s manufacturing sites are subject to periodic inspection by the FDA for compliance with the FDA’s Quality System Regulations.
The company’s international operations subject the company to laws regarding sanctioned countries, entities and persons, customs, import-export, laws regarding transactions in foreign countries, the U.S. Foreign Corrupt Practices Act of 1977, and local anti-bribery and other laws regarding interactions with healthcare professionals.
Research and Development
The company’s research and development costs were $16.3 million in 2020.
Competition
The company’s primary competitors in the combined orthobiologics and spinal implant markets include Alphatec Spine, Baxter, Bioventus, Cerapedics, DePuy Synthes Spine (a Johnson & Johnson company), Globus Medical, Medtronic, NuVasive, Orthofix, Stryker, Surgalign, XTANT Medical, and Zimmer-Biomet.
History
SeaSpine Holdings Corporation was incorporated in Delaware in 2015.
