NuVasive, Inc., a global medical technology company, focuses on developing, manufacturing, selling and providing procedural solutions for spine surgery, with a guiding purpose to transform surgery, advance care and change lives.
The company offers a portfolio of procedurally integrated spine surgery solutions, including surgical access instruments, spinal implants, fixation systems, biologics, and enabling technologies, as well as systems and services for intraoperative neuromonitoring. In addi...
NuVasive, Inc., a global medical technology company, focuses on developing, manufacturing, selling and providing procedural solutions for spine surgery, with a guiding purpose to transform surgery, advance care and change lives.
The company offers a portfolio of procedurally integrated spine surgery solutions, including surgical access instruments, spinal implants, fixation systems, biologics, and enabling technologies, as well as systems and services for intraoperative neuromonitoring. In addition, it develops and sells magnetically adjustable implant systems for spine and specialized orthopedic procedures.
The company’s portfolio of solutions can be utilized in procedures for the cervical, thoracic and lumbar spine, supporting surgical approaches from the anterior, including lateral, and posterior. The company’s solutions are used to treat degenerative conditions and for complex spinal surgery, including adult and pediatric deformities, as well as trauma and tumors.
Commercial Products
The company’s procedurally integrated spine surgery solutions are designed to allow surgeons to perform a wide range of less-invasive surgical procedures with less tissue disruption of the spine, in all regions of the spine and from various surgical approaches, while overcoming the shortcomings of traditional minimally invasive spine surgical techniques. The company’s solutions are designed to treat a wide range of spinal pathologies while accommodating a surgeon’s preferred surgical technique.
The company’s products and technology facilitate less-invasive applications of the following spine surgery procedures, among others:
Decompression, which is removal of a portion of bone or disc from over or under the nerve root to relieve impingement of the nerve;
Lumbar and thoracic fusion procedures in which the surgeon approaches the spine through the patient’s back (posterior), side (lateral) or abdomen (anterior);
Cervical fusion procedures, for either the posterior occipito-cervico-thoracic region or the anterior cervical region, and motion-preserving cTDR procedures; and
Complex cases involving adult and pediatric spinal deformity, trauma and tumor patients.
The company offers a portfolio of procedurally integrated spine surgery solutions, including surgical access instruments, spinal implants, fixation systems, biologics, and enabling technologies, as well as systems and services for IONM. In addition, it develops and sells magnetically adjustable implant systems for spine and specialized orthopedic procedures.
Surgical Access Instruments
The company has differentiated surgical access instruments that surgeons use to access the surgical site, including its Maxcess integrated split-blade retractor system, designed to minimize soft tissue disruption during spine surgery. The company’s Maxcess retractors have a split-blade design consisting of three blades that can be positioned to customize the surgical exposure in the shape and size specific to the surgical requirements rather than the more traditional fixed tube or two-blade designs of traditional minimally invasive spine surgical systems. This split-blade design also provides customizable access to the spine, which allows surgeons to perform surgical procedures using instruments that are similar to those used in open procedures but with a smaller incision and less tissue disruption. The ability to use familiar instruments reduces the learning curve for the company’s procedures and facilitates the adoption of its products. The company’s system’s illumination of the operative corridor aids in providing surgeons with better direct visualization of the patient’s anatomy, without the need for additional technology or other special equipment, such as endoscopes.
Over the years, the company has made improvements to its Maxcess systems, including incorporating enabling technologies and improving the blade systems. The company’s Maxcess products are used in the cervical spine for posterior application and anterior retraction, the lumbar spine for decompressions, transforaminal lumbar interbody fusions, or TLIFs, posterior lumbar interbody fusions, or PLIFs, the thoracolumbar spine for XLIFs, and the thoracic region for tumors and trauma, as well as in adult degenerative scoliosis procedures. Additionally, the Maxcess system is integrated into its X360 procedure which allows surgeons to conduct lateral single-position spine surgery without repositioning the patient.
Implants and Fixation Systems
The company has many specialized implants and fixation products designed to be used as part of its procedurally integrated solutions. Its portfolio of spinal implants used for intervertebral disc height restoration include implants made from allograft, titanium, and PEEK. These spinal implants come in a variety of shapes, sizes, and lordosis options to accommodate specific approach, pathology, alignment restoration, and anatomical requirements of the patient and the particular fusion procedure. The company’s Advanced Materials Science portfolio of implants, designed to improve spinal fusion by enhancing the osseointegration and biomechanical properties of implant materials, includes its Modulus porous titanium implants and Cohere and Coalesce porous PEEK implants. The company’s implants are designed for insertion into the smallest possible space while maximizing surface area contact for fusion.
Following the company’s acquisition of Simplify Medical during the first quarter of 2021, it also offers cervical artificial disc technology for cervical total disc replacement (cTDR) procedures. The company’s fixation products, including pedicle screws, rods and plates, have been uniquely designed and include a highly differentiated percutaneous minimally invasive solution with advanced guide technology, superior rod insertion options, and multiple reduction capabilities to be delivered through its procedures to provide stabilization of the spine. The Reline portfolio consists of innovative posterior fixation technology designed to preserve and restore spinal alignment, while addressing a wide range of spinal pathologies. The company’s Reline portfolio can be used in both traditional open procedures and less-invasive surgical procedures and includes fixation products for cervical, thoracic and lumbar spine, as well as Reline Trauma and Reline Small Stature for complex spinal surgery.
Biologics
The company offers a variety of biologics that are used to aid in the spinal fusion or bone healing process. The global biologics market in spine surgery consists of autograft (autologous human tissue), allograft (donated human tissue), and a varied offering of synthetic products and growth factors. The company’s allograft biologics product offerings include Osteocel Plus and Pro, a cellular bone matrix designed to mimic the biologic profile of autograft, including mesenchymal stem cells and osteoprogenitor cells to aid in spinal fusion, and Propel DBM (highly moldable demineralized bone matrix putty and gel). Its synthetic biologics product offerings include Formagraft (collagen-based synthetic bone substitute) and AttraX (synthetic bone graft material delivered in putty and other forms).
Intraoperative Neuromonitoring Systems
The company’s intraoperative neuromonitoring (IONM) systems utilize proprietary software hunting algorithms and graphical user interfaces to provide surgeons with an enhanced and intuitive nerve avoidance system. The company’s systems function by monitoring changes in electrical signals across muscle groups, which allows it to detect underlying changes in nerve activity. Through its IONM platforms, the company gives surgeons the option to connect their instruments to a computer system that provides discrete, real-time, surgeon directed and surgeon controlled feedback about the directionality and relative proximity of nerves during surgery.
The company’s systems analyze and then translate complex neurophysiologic data into simple, useful information to assist the surgeon’s clinical decision-making process. Surgeons can connect certain instruments to the company’s IONM systems, thus creating an interactive set of instruments that better enable the safe navigation through the body’s nerve anatomy during surgery. The connection is accomplished using a clip that is attached to the instrument, effectively providing the benefits of the company’s IONM systems through an instrument already familiar to the surgeon. The company’s proprietary software and easy to use graphical user interfaces allow the surgeon to make critical decisions in real time to help enable safer, faster, and more reproducible procedures to achieve improved patient outcomes.
Intraoperative Neuromonitoring Services
Through its NCS subsidiary, the company provides onsite and remote monitoring of the neurological systems of patients undergoing spinal and brain-related surgeries. The company’s neurophysiologists are present in the operating room during procedures and work in partnership with supervising physicians who remotely oversee and interpret neurophysiological data gathered via broadband transmission over the internet. Through this service, data can be analyzed in real-time by healthcare professionals for additional interpretation of intraoperative information and oversight.
Enabling Technology
The integration of enabling technology into the company’s procedural offerings is integral to its strategy. Its investment in enabling technology is focused on its Pulse platform which is designed to further improve clinical, financial, and operational outcomes of spine surgery. Pulse integrates multiple hardware technologies into a single unit of capital equipment with two fixed screens in the operating room. The company has incorporated into the Pulse platform existing technologies in its portfolio, including IONM, rod bending, and Lessray image enhancement, which is designed to help surgeons and hospital staff manage radiation exposure by using digital imaging processing technology to generate high resolution images of the surgical field from low resolution images. Pulse also includes navigation, spinal alignment tools, and other features designed to improve operating room workflow for all spine cases. Pulse seeks to facilitate and optimize clinical decision making while maintaining surgeon control through integrated technologies that inform one another—producing a seamless and efficient workflow. Pulse is designed to increase safety, efficiency, and surgical procedure reproducibility, while addressing some of the most common clinical challenges in spine surgery. Pulse offers wireless device capabilities, allowing connectivity and control of the Pulse platform from all members of the surgical team in the operating room. Its extensible architecture can support future surgical applications as the company continues to invest and develop this technology platform.
Specialized Orthopedics
Through its NuVasive Specialized Orthopedics, or NSO, subsidiary, the company develops and manufactures magnetically adjustable spine and orthopedics products using the MAGEC technology. The company’s MAGEC system is designed to overcome the limitations of conventional adjustable rod treatments for early onset scoliosis, or EOS, and reduce the number of surgical procedures required throughout childhood. EOS refers to severely deformed curvatures of the spine diagnosed before the age of ten. EOS is a challenging health issue and can lead to more severe progressive deformities. Once the company’s magnetically adjustable MAGEC growing rods are surgically implanted in a patient, they can be adjusted non-invasively using an external remote controller. The ability to adjust growing rods without surgical intervention means that EOS patients can be treated with fewer planned surgeries. The company’s non-invasive adjustment technology enables physicians to perform more frequent adjustments in a non-surgical outpatient setting, thereby improving deformity correction and allowing for optimal spinal growth.
The proprietary MAGEC technology is also the basis for the Precice system, which is designed to support complex orthopedic reconstruction, such as trauma and limb length discrepancy, or LLD. The Precice system uses a specialized intramedullary nail that, once surgically implanted, is lengthened using the MAGnetic External Control (MAGEC) technology, which enables non-invasive and painless adjustments using a pre-programmed external remote controller. As a result, Precice enables physicians to customize therapy to the needs of the patient over time without the need for surgical re-intervention and provides improved quality of life and satisfaction for patients in need of surgical limb lengthening.
Strategy
The key elements of the company's strategy are to advance its position in less-invasive spine surgery; continue to develop innovative solutions and broaden its portfolio of offerings; strengthen proceduralization supported by enabling technologies and surgeon education; expand the reach of its sales force and drive growth globally; selectively license or acquire complementary products and technologies; and provide intraoperative neuromonitoring capabilities.
International
The company’s procedurally integrated solutions and technologies treat similar pathologies around the world, it focuses on expanding its operations in select international markets. The company is investing to tailor its products and technologies to meet varying international patient, surgeon and market requirements. It is also investing in its global infrastructure to adapt alternative distribution channels, to support differing language and customer service requirements, and to provide training and surgeon education in its surgical techniques, instruments, products and technologies to its international customers.
Sales and Marketing
In the United States (U.S.), the company sells its procedurally integrated solutions through a combination of exclusive and non-exclusive independent sales representatives and directly-employed sales force. Each member of its U.S. sales force is responsible for a defined territory, with its exclusive independent sales representatives acting as its sole representative in their respective territories. The company’s international sales force is consisted of directly-employed sales representatives, as well as distributors and independent sales representatives. Directly-employed sales representatives make up the majority of the company’s overall sales force.
Surgeon Training and Education
The company devotes significant resources to training and educating surgeons regarding the safety and reproducibility of its surgical techniques and its procedurally integrated solutions. The company’s surgeon education and training program is led by its Clinical Professional Development team, and integrates surgical training with professional development and enables it to introduce surgeons to its less-invasive approaches to spine surgery. Internationally, the company provides surgeon training and education in Amsterdam, the Netherlands, to support surgeons primarily within the European region. Additionally, the company offers educational and training courses globally through in-person formats and via virtual content, including through virtual conferences, video and social channels, to demonstrate the benefits of its innovative products and procedures.
Surgical Instrument, Implant Sets and Equipment Sales
For many of its customers, the company provides surgical instrumentation sets, including both implants and instruments, as well as its IONM systems in a manner tailored to fulfill its customer’s obligations to meet surgery schedules.
Intellectual Property
Patents
As of December 31, 2022, the company had over 1,500 issued patents and pending applications world-wide, including over 750 issued U.S. patents. The company’s issued patents and pending applications cover, among other things, surgical access instrumentation and methodology, relating to its eXtreme Lateral Interbody Fusion procedure (XLIF) and X360 procedures and aspects thereof, as well as technologies and methods related to its C360 portfolio; artificial discs, including the Simplify Cervical Disc and related instrumentation; neurophysiology enabled instrumentation and methodology, including pedicle screw test systems, software hunting algorithms, navigated guidance, rod bending and surgical access systems; spinal implants and related instrumentation and targeting systems; biologics, including Osteocel Plus and Osteocel Pro, Formagraft and AttraX; magnetic technology for non-invasive distraction of an implanted device, including the MAGEC technology platform; digital imaging processing technology that generates high resolution images of the surgical field from low resolution scans, including the Lessray technology platform; porous polyetheretherketone (PEEK) technology, included in its Cohere and Coalesce spinal implants; and surgical navigation and robotics technology. Its issued patents began to expire in 2018.
Trademarks
As of December 31, 2022, the company had over 400 trademark registrations in both domestic and foreign regions.
Competition
In its core spine business, the company’s significant competitors are Medtronic, DePuy/Synthes, a Johnson & Johnson company, Stryker Spine, Globus Medical, Inc. (Globus Medical), and ZimVie. The company also faces competition from a significant number of smaller spine companies with more limited product offerings and geographic reach than its larger competitors. These companies, who represent intense competition in specific markets, include Orthofix Medical and Alphatec Holdings. With respect to the company’s neuromonitoring and other enabling technologies, it primarily competes with Medtronic and Globus Medical. The company’s NCS subsidiary competes with SpecialtyCare. Its NSO subsidiary competes with divisions of traditional orthopedics companies, including Stryker Orthopedics and Smith & Nephew, as well as Orthofix Medical.
Government Regulation
The company’s outsourcing strategy is targeted at companies that meet the U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO), and quality standards supported by internal policies and procedures. Like the company’s relationships with its device manufacturing suppliers, it subjects its tissue processing suppliers to the same quality criteria in terms of selection, qualification, and verification of processed tissue quality upon receipt of goods, as well as hold them accountable to compliance with FDA regulations, state requirements, and voluntary industry standards (such as those put forward by the American Association of Tissue Banks).
The company and its third-party manufacturers are subject to the quality system regulations of the FDA, state regulations (such as the regulations promulgated by the California Department of Health Services), and regulations promulgated by foreign regulatory bodies (such as in the European Union). For tissue products, the company is FDA registered and licensed in the States of California, Delaware, Florida, Illinois, Maryland, New York, and Oregon. For its device implants and instruments, the company is FDA registered, California licensed, CE marked and ISO certified.
The company’s products are medical devices and human tissue products subject to extensive regulation by the FDA and other regulatory bodies both inside and outside of the U.S. Each of these agencies requires it to comply with laws and regulations governing the development, testing, manufacturing, storage, labeling, marketing and distribution of its products. Unless an exemption applies, each medical device that the company markets and sells in the U.S. must first receive either 510(k) clearance (by submitting a premarket notification) or premarket approval (by filing a premarket approval application, or PMA) from the FDA.
The company’s allograft products, including its Triad and ExtenSure, and its Osteocel Plus, Osteocel Pro, and Propel products, are regulated by the FDA as Human Cell, Tissue, and Cellular and Tissue Based Products.
The company is required to register with the FDA as a provider of such products and to list these products with the FDA and comply with its Current Good Tissue Practices for Human Cell, Tissue, and Cellular- and Tissue-Based Product Establishments. Entities that provide it with allograft bone tissue are responsible for performing donor recovery, donor screening, donor testing, processing, and packaging and the company’s compliance with those aspects of the Current Good Tissue Practices regulations that regulate those functions are dependent upon the actions of these independent entities.
The company is also subject to announced and unannounced inspections by the FDA, the California Food and Drug Branch, American Association of Tissue Banks, as well as other regulatory agencies overseeing the implementation and adherence of applicable state and federal device and tissue licensing regulations.
The company is subject to the federal Anti-Kickback Statute which, among other things, prohibits the knowing and willful solicitation, offer, payment or receipt of any remuneration, direct or indirect, in cash or in kind, in return for, or to induce the referral of patients for, items or services covered by Medicare, Medicaid and certain other governmental health programs. It is also subject to the UK Bribery Act, which would also subject it to the imposition of civil and criminal fines.
The Sunshine Act (Physician Payments Sunshine Act of 2009) requires that the company files an annual report on March 31 of a calendar year for the transfers of value incurred for the prior calendar year. Data protection laws, including the European Union (EU) General Data Protection Regulation, or GDPR, also apply to the company’s international operations.
History
NuVasive, Inc. was founded in 1997. The company was incorporated in Delaware in 1997.
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