Profile: NuVasive, Inc. (NUVA.O)

NuVasive, Inc. (NuVasive), incorporated on July 21, 1997, is a medical device company focused on the design, development and marketing of products for the surgical treatment of spine disorders. The Company’s principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery (MAS), as well as an offering of cervical, biologics and motion preservation products. As of December 31, 2008, the Company’s marketed products were used in spine fusion surgeries, both to enable access to the spine, and to perform restorative and fusion procedures. It focuses on the research and development efforts on MAS product platform, and on developing motion preserving products, such as total disc replacement and nucleus-like cervical disc replacement.

The Company’s MAS platform combines four categories of its product offering, NeuroVision, a software-driven nerve avoidance system; MaXcess, a split-blade design retraction system providing surgical access to the spine; Biologics, which includes its FormaGraft and Osteocel line of products, and Specialized implants, which includes its SpheRx pedicle screw system, and CoRoent suite of implants. NeuroVision enables surgeons to navigate around nerves while MaXcess affords direct customized access to the spine for implant delivery. MaXcess also allows surgeons to use traditional instruments in a minimally disruptive and less traumatic manner, while its biologics offering compliments the Company’s MAS platform by facilitating fusion. It also offers a variety of specialized implants that enable structural support while conforming to the anatomical requirements of the patient. It also offers a suite of traditional spine surgery products, including certain products in its CoRoent suite of implants, a titanium surgical mesh system, a line of precision-machined cervical and lumbar allograft implants, and related instrumentation. Its Triad and Extensure lines of bone allograft, in its saline packaging, are human bone that has been processed and precision shaped for transplant. The Company also offers fusion fixation products that offer technological benefits, such as its Gradient Plus cervical plate and SpheRx pedicle screw system.

MAS-NeuroVision

NeuroVision utilizes electromyography (EMG), and algorithms and graphical user interfaces to provide surgeons with a nerve avoidance system. Its system functions by monitoring changes in electrical signals across muscle groups, which allows it to detect underlying changes in nerve activity. The Company connects the instruments that surgeons use to a computer system that provides real time feedback during surgery. The system analyzes and then translates complex neurophysiologic data into simple, useful information to assist the surgeon’s clinical decision-making process. In addition, during a pedicle screw test, in which the integrity of the bone where the implant is placed is tested, if the insertion of a screw results in a breach of the bone, a red light and corresponding numeric value will result so that the surgeon may reposition the implant to avoid potential nerve impingement or irritation. If no breach of the bone occurs, a green light and corresponding numeric value will result.

MAS-MaXcess

The Company’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. 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 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.

MaXcess II is a second generation of the Company’s MaXcess retractor that incorporates NeuroVision within the posterior retraction blade, providing built-in nerve monitoring capabilities. MaXcess III is a further enhancement of the previous MaXcess systems (the MaXcess and MaXcess II systems). MaXcess III maintains the split-blade design and continues to incorporate NeuroVision nerve avoidance technology within the posterior retraction blade. MaXcess-Micro Access System is a product that brings all of the benefits of minimally disruptive surgery to both the cervical spine for posterior application and the lumbar spine for decompression.

MAS-Specialized Implants

NuVasive’s implants are used for interbody disc height restoration for fusion, partial vertebral body replacement and stabilization of the spine. These implants include its SpheRx, SpheRx II and SpheRx II DBR pedicle screw systems, its XLP Lateral Plate, its CoRoent family of implants for partial vertebral body replacement and interbody implants, precision-machined allograft implants, as well as numerous new implants under development. 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. The fixation systems have been designed to be delivered through the Company’s MaXcess system to provide stabilization of the spine. These systems enable minimally disruptive placement of implants and are intended to reduce operating time and patient morbidity. The Company’s traditional product offerings also include fusion plates, such as its SmartPlate Gradient CLP, a cervical plate that encompasses a gradient locking mechanism, which gradually loads the screws based upon the anatomic requirements. Its motion preservation product development efforts include mechanical lateral total disc replacement (XL TDR).

MAS — Biologics

As part of its MAS offering, the Company expanded its product offerings to include products in the biologics market. The biologics market consists of autograft (autologous human tissue), allograft (donated human tissue), a varied offering of synthetic products, stem cell-based products, and growth factors. During 2008, it acquired Osteocel, an allograft cellular matrix containing viable MSCs to aid in fusion. The Company also made an investment in Progentix Orthobiology BV, a company working to develop a synthetic biologic.

The Company competes with Medtronic Sofamor Danek, Cadwell, Nicolet Biomedical, Johnson & Johnson, Stryker Spine and Synthes, Inc.