NuVasive Inc was incorporated in Delaware on July 21, 1997, and began commercializing its products in 2001. It is a medical device company engaged in developing minimally disruptive surgical products and procedures for the spine. The Company's current-marketed product portfolio is engaged in applications for spine fusion surgery, including biologics. The Company's product offering includes a minimally disruptive surgical platform called Maximum Access Surgery, or MAS. The MAS platform combines three categories of solutions that collectively minimize soft tissue disruption during spine fusion surgery, provide maximum visualization and are designed to enable safe and reproducible outcomes for the surgeon and the patient. The platform includes its proprietary software-driven nerve detection and avoidance systems, NVM5 and NVJJB, and Intra-Operative Monitoring (IOM) support; MaXcess, an integrated split-blade retractor system; and a variety of specialized implants. The Company's primary business model is to loan its MAS systems to surgeons and hospitals that purchase implants, biologics and disposables for use in individual procedures. In addition, for larger customers, the Company's proprietary nerve monitoring systems, MaXcess and surgical instrument sets are placed with hospitals for an extended period at no up-front cost to them. The Company also offers a range of bone allograft in patented saline packaging, disposables and spine implants, which include its branded CoRoent products and fixation devices such as rods, plates and screws. Implants, biologics and disposables are shipped from the Company's inventories. The Company sells an immaterial quantity of MAS instrument sets, MaXcess and nerve monitoring systems to hospitals. Its spine surgery product line offerings, which include products for the thoracolumbar and the cervical spine, are used to enable access to the spine and to perform restoration and fusion procedures in a minimally disruptive fashion. In the United States, it currently sells its products through a combination of exclusive independent sales agencies and directly-employed sales shareowners. The Company has approximately 230 issued U.S. patents, 165 foreign national patents, and 284 pending patent applications. The Company's competitors are Medtronic Sofamor Danek (Medtronic), DePuy/Synthes, a Johnson & Johnson company, Stryker Spine, Globus Medical, Biomet Spine, and Zimmer Spine. It also faces competition from physician owned distributorships (PODs), which are medical device distributors that are owned, directly or indirectly, by physicians. The Company's products,medical devices and tissues subject to regulation by the FDA and other regulatory bodies.
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