Profile: NuVasive Inc (NUVA.OQ)
23 Sep 2016
Nuvasive, Inc., incorporated on July 21, 1997, is a medical device company in the spine market. The Company focuses on developing minimally-disruptive surgical products and procedurally-integrated solutions for the spine. The Company offers two product lines: spine surgery products and biologics. The Company's spine surgery products line offerings include thoracolumbar product offerings, cervical product offerings, Intra-Operative Monitoring (IOM) services and disposables, which are used to enable access to the spine and to perform restorative and fusion procedures in a minimally disruptive fashion. The Company's biologics product line offerings includes allograft (donated human tissue), FormaGraft (a collagen synthetic product), Osteocel Plus and Osteocel Pro (each an allograft cellular matrix containing viable mesenchymal stem cells (MSCs)), and AttraX (a synthetic bone graft material), all of which are used to aid the spinal fusion or bone healing process.
The Company's product offering includes a minimally-disruptive surgical platform called Maximum Access Surgery (MAS). The MAS platform combines over three categories of solutions that collectively minimize soft tissue disruption during spine fusion surgery, provide visualization and are designed to enable reproducible outcomes for the surgeon and the patient. The platform includes the Company's software-driven nerve detection and avoidance systems, including NVM5 and IOM services and support; MaXcess, which is an integrated split-blade retractor system, and a range of implants and biologics. The Company's products, including the individual components of its MAS platform are used in open or traditional spine surgery. The Company's MAS platform allows surgeons to perform a range of minimally-disruptive spine procedures in all regions of the spine. The platform is designed to treat a range of spinal pathologies. Its MAS platform combines over three product categories: the Company's MaXcess retractors, its specialized implants and fixation products, and nerve monitoring systems and service offerings. These collectively enable surgeons to detect and navigate around nerves while directing access to the spine for implant delivery. Its products facilitate minimally-disruptive applications of various surgery procedures: lumbar and thoracic fusion procedures in which the surgeon approaches the spine through the patient's back, side or abdomen; cervical fusion procedures for either the posterior occipito-cervico-thoracic region or the anterior cervical region, and decompression, which is the removal of a portion of bone or disc from over or under the nerve root to relieve pinching of the nerve.
MaXcess retractors have a split-blade design consisting of over 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. Its system's illumination of the operative corridor aids in providing surgeons with direct visualization of the patient's anatomy, without the need for additional technology or other special equipment, such as endoscopes. Its MaXcess products are used in the cervical spine for posterior application and anterior retraction, the lumbar spine for decompressions, transforaminal lumbar interbody fusions (TLIFs) and posterior lumbar interbody fusions (PLIFs), the thoracolumbar spine for eXtreme Lateral Interbody Fusion (XLIFs), and the thoracic region for tumors and trauma, as well as in adult degenerative scoliosis procedures.
Implants and Fixation Systems
The Company has implants and fixation devices designed to be used with its MAS platform. These implants are used for interbody disc height restoration include implants made from allograft, titanium and polyetheretherketone (PEEK). Its CoRoent family of implants, which are made from PEEK, are available in a range of shapes and sizes to accommodate specific approach, pathology and anatomical requirements of the patient and the particular fusion procedure. Its implants are designed for insertion into the smallest possible space while maximizing surface area contact for fusion. Its fixation products, including pedicle screws, rods and plates, have been designed and include a differentiated percutaneous minimally invasive solution with guide technology, superior rod insertion options and multiple reduction capabilities to be delivered through its procedures to provide stabilization of the spine. Its fixation offerings include its Precept and ReLine posterior fixation portfolios.
The Company's nerve monitoring systems utilize electromyography (EMG), as well as software hunting algorithms and graphical user interfaces to provide surgeons with a nerve avoidance system. The Company's systems function by monitoring changes in electrical signals across muscle groups, which allows the Company to detect underlying changes in nerve activity. Through the NVM5 platform, 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 information to assist the surgeon's clinical decision-making process. The health and integrity of the spinal cord and related nerves can also be assessed using motor evoked potentials (MEPs) and somatosensory evoked potentials (SSEPs). Both of these methods of IOM involve applying stimulation and recording the response that must travel along the motor or sensory paths of the spinal cord. In addition to its MAS platform, the Company's procedural solution includes its biologics products, IOM services, and iGA technology.
Intraoperative Monitoring Services
Through its IOM services business, the Company provides sonsite and remote monitoring of the neurological systems of patients undergoing spinal and brain-related surgeries. Its neurophysiologists are present in the operating room during procedures and work in partnership with physicians who remotely oversee and interpret neurophysiological data gathered through 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.
Integrated Global Alignment
The Company's iGA platform offers an approach for assessing, preserving and restoring spinal alignment. Using its NuvaPlanning portfolio of software solutions, NuvaMap, NuvaLine and NuvaMap O.R., surgeons can preoperatively calculate and evaluate alignment parameters and implant integration by modeling surgery to create a reliable plan with results, and then conduct a real-time interoperative assessment in order to correct the anterior and posterior column alignment in line with the surgical plan. In addition to its software solutions, the Company also offers products that are designed to restore alignment, including its ReLine posterior fixation portfolio and its Bendini spinal rod bending system. It offers products that leverage the MAGEC and PRECICE technology to treat the unmet clinical needs of children who suffer from early onset scoliosis and patients who suffer from limb length discrepancies.
The Company competes with Medtronic Sofamor Danek, Johnson & Johnson, Stryker Spine, Globus Medical, Biomet Spine, Biotronic NeuroNetwork, Becton, Dickinson and Company, Zimmer Spine, Orthofix International N.V., Alphatec Spine, Landauer and K2M.
7475 Lusk Blvd
SAN DIEGO CA 92121-5707