Profile: NuVasive Inc (NUVA.OQ)
e, Inc. (NuVasive), incorporated on July 21, 1997, is a medical device company. NuVasive focuses on developing minimally disruptive surgical products and procedures for the spine. During the year ended December 31, 2012, its marketed product portfolio focused on applications for spine fusion surgery, including biologics. Its principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery (MAS), as well as offering of biologics, cervical and motion preservation products. NuVasive’s spine surgery product line offerings, which include products for the thoracolumbar spine, the cervical spine, and a set of motion preservation product offerings under development, are primarily used to enable access to the spine and to perform restorative and fusion procedures in a minimally disruptive fashion. Its biologic product line offerings include allograft (donated human tissue), FormaGraft, a collagen synthetic product used to aid the fusion process, and Osteocel Plus, an allograft cellular matrix containing viable mesenchymal stem cells (MSCs), to aid in spinal fusion. In May 2013, the Company acquired ANC, LLC.
NuVasive’s MAS platform combines four categories of its product offerings: NV M5 and NV JJB, its software-driven nerve monitoring systems; MaXcess, a split-blade design retraction system providing enhanced surgical access to the spine; Biologics, which includes its FormaGraft and Osteocel Plus line of products, and Specialized implants, which includes its SpheRx and Armada pedicle screw systems, CoRoent suite of implants, and several fixation systems. The Company’s cervical product offering provides a set of solutions for cervical fusion surgery, including both allograft and CoRoent implants, as well as cervical plating and posterior fixation products.
The Company’s MAS platform allows surgeons to perform a range of minimally disruptive procedures, while overcoming the shortcomings of traditional minimally invasive spine surgical techniques. It also offers a variety of specialized implants that enable the maximization of disc height restoration and sufficient structural support while conforming to the anatomical requirements of the patient.
MAS - Nerve Monitoring
The Company’s nerve monitoring systems utilize electromyography (EMG) software hunting algorithms and graphical user interfaces to provide surgeons with an enhanced nerve avoidance system. Its systems function by monitoring changes in electrical signals across muscle groups, which allows it to detect underlying changes in nerve activity. NuVasive connects the instruments that surgeons use to a computer system that provides real time, surgeon directed and surgeon controlled feedback during surgery. Its systems analyze and then translate complex neurophysiologic data into simple, useful information to assist the surgeon’s clinical decision-making process.
Surgeons can link familiar surgical instruments to the Company’s nerve monitoring systems, thus creating an interactive set of instruments that enable the safe navigation through the body’s nerve anatomy. The connection is accomplished using a clip that is attached to the instrument, providing the benefits of its nerve monitoring systems through an instrument already familiar to the surgeon. The systems’ software and graphical user interface enables the surgeon to make critical decisions in real time. With recent additions, the health and integrity of the spinal cord can also be assessed using motor evoked potentials (MEPs) and somatosensory evoked potentials (SSEPs). Both methods of intraoperative monitoring involve applying stimulation and recording the response that must travel along the motor or sensory paths of the spinal cord. The data developed using its nerve monitoring systems can be sent to health care professionals for additional interpretation of intra-operative information.
NuVasive’s MaXcess system consists of instrumentation and specialized implants that provide maximum access to the spine with minimal soft tissue disruption. MaXcess has a split blade design consisting of three blades that can be positioned to build the surgical exposure in the shape and size specific to the surgical requirements rather than the fixed tube design of minimally invasive spine surgical systems. MaXcess’ split blade design also provides expanded 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 significantly smaller incision. The ability to use familiar instruments reduces the learning curve and facilitates the adoption of its products. The Company’s 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.
The Company’s MaXcess products are used in the cervical spine for posterior application, the lumbar spine for decompression, transforaminal interbody fusion (TLIF). Its MaXcess products have been used in the thoracic region as the lateral approach has broadened from the lumbar to the thoracic region, as well as into adult degenerative scoliosis procedures.
MAS - Specialized Implants
NuVasive has a number of implants designed to be used with its MAS platform. These implants are used for interbody disc height restoration for fusion and stabilization of the spine. The Company’s implants are available in a variety of shapes and sizes to accommodate the 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 systems have been uniquely designed to be delivered through its MaXcess system to provide stabilization of the spine. These systems enable minimally disruptive placement of implants and are intended to reduce patient morbidity, often through a single approach.
The biologics market in spine surgery consists of autograft (autologous human tissue), allograft (donated human tissue), a varied offering of synthetic products, stem cell-based products, and growth factors. As of 2012, the Company offers FormaGraft, a collagen-based synthetic bone substitute, and Osteocel Plus, an allograft cellular matrix designed to mimic the biologic profile of autograft that includes endogenous MCSs and osteoprogenitors to aid in fusion.
The Company competes with Globus Medical, Inc., Zimmer Spine, Orthofix International N.V. (Orthofix), Biomet EBI/Spine, Alphatec Spine, Inc. (Alphatec), K2M, Inc., DePuy Spine, Inc., Stryker Spine, Synthes, Inc., Medtronic Sofamor Danek (Medtronic), Natus, Cadwell Laboratories, VIASYS Healthcare, Nutech Medical, Inc., and the Musculoskelatal Transplant Foundation.
7475 Lusk Blvd.
SAN DIEGO CA 92121