NuVasive, Inc. (NASDAQ:NUVA) , a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today the launch of five new products within the Company's MAS(TM) Platform. The products are the MaXcess(TM) II retraction system, the CoRoent(TM) Large Contoured System, the CoRoent(TM) XLR System, several enhancements to the Company's NeuroVision(R) nerve avoidance system and ExtendSure, an interspinous dynamic stabilization and fusion product.
MaXcess II(TM) is an enhancement of the Company's current MaXcess system, with the addition of several features to allow for greater access to the spine. The new product maintains the split-blade design retraction system, providing maximum access to the patient's spine with minimal tissue disruption. MaXcess II features three blades that slide down over NuVasive's NeuroVision(R) dilators and gently spread apart the patient's tissue. The superior and inferior blades "kick-out" at an angle, spreading the tissue closest to the pathology point further than the original MaXcess system. MaXcess II allows for greater exposure and access to the spine while requiring no greater incision at the skin. MaXcess II also incorporates the Company's NeuroVision nerve avoidance technology within the posterior retraction blade. This allows surgeons to dynamically test for surrounding nerves during the entire procedure, including pedicle screw testing and implant placement. The entire retraction system is also radiolucent, or translucent to X-Rays, allowing the surgeon full view of the pathology point during fluoroscopy.
CoRoent Large Contoured is designed specifically for a transforaminal approach to the lumbar region of the spine, in which the surgeon approaches at an angle through the patient's back. The product features a curved and bullet-nosed design that closely matches the patient's anatomy. The product's large surface area allows for a uniform load distribution.
CoRoent XLR is designed for an anterior or anterolateral approach to the lumbar region of the spine and features a wide, rounded surface area to maximize the implant's contact with the anatomy.
The CoRoent Large Contoured Implant and CoRoent XLR Systems are specially designed to allow for simplicity of surgeon placement and proper anatomical fit in the spine. Both systems are radiolucent, giving the surgeon a full view of the anatomy during surgery and include radio dense titanium markers, enabling the surgeon to visually confirm their correct positioning. CoRoent products are made of PEEK OPTIMA(R), a biocompatible polymer commonly used in implantable devices.
NuVasive has also made enhancements to its NeuroVision(R) nerve avoidance system in the form of a software upgrade and improved nerve monitoring capabilities. The software upgrade incorporates a new graphical user interface that allows for greater ease of use by the surgical staff. NeuroVision(R) has also been given a new harness and dual electrodes, or redesigned connectors, to streamline the application of surface electrodes that relay muscle activity to the NeuroVision(R) nerve monitoring system.
NuVasive's ninth and final product launch for 2005, ExtendSure, will be unveiled during its participation in the North American Spine Society's (NASS) 20th Annual Meeting. ExtendSure is an interspinous dynamic stabilization and fusion product that allows decompression through a more natural restoration of the spinal anatomy. ExtendSure's primary indication is for lumbar spinal stenosis.
The launch of these five new products completes the Company's planned launch of nine new products in 2005. The four additional products launched in 2005 include:
* SpheRx(TM) Dual Ball Rod (DBR(TM)) Minimally Disruptive Fixation System
- - a pedicle screw system that allows for instrument-free compression of the vertebrae, minimizes the incidence of tissue trauma associated with rod-overhang and ensures secure rod placement with minimal rod migration;
* SmartPlate Gradient CLP -- a dynamic cervical plate that encompasses a gradient locking mechanism enabling the screws to be progressively resistant to axial compression. This allows the plate to settle in concert with the eventual allograft implant settling that occurs within the disc space over time, offering a better anatomical fit;
* Insulated Pedicle Access System (I-PAS) -- a surgical instrument used in conjunction with NeuroVision to determine the safe, percutaneous approach pathway of a pedicle screw prior to its implantation. I-PAS is the first percutaneous and dynamic neurophysiologic system on the market to continuously monitor and alleviate the risk of neurological injury during pedicle screw placement;
* CoRoent Large Tapered -- shaped to better match the patient's anatomy, CoRoent Large Tapered is designed to be inserted using a patented "Insert and Rotate" technique, which minimizes damage to the surrounding bone. This procedure allows the surgeon to restore height and stability of the spine.
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "The launch of these five innovative products marks the completion of a very successful year of introducing products that continue to place NuVasive at the forefront of providing surgeons with the latest minimally disruptive spine surgery technology. We are particularly excited about the launch of MaXcess II, which we believe provides surgeons with the greatest access to the spine in a minimally disruptive procedure available on the market. We believe MaXcess II will broaden our penetration of the spine market and allows for increased pull-through of our implants such as SpheRx DBR. ExtendSure is a unique product that will be the first of its kind on the market for the indication of lumbar spinal stenosis. ExtendSure will be launched at NASS as a limited release with a full launch anticipated in the first half of 2006. The CoRoent XLR and Large Contoured Systems were designed in response to the demand from spine surgeons for an implant with superior anatomical fit that is simple to position and align. Initial feedback from surgeons on all of the products launched in 2005 has been very positive. We will continue to execute our strategy of introducing new products and making our own products obsolete to stay ahead of the competition with the continued vertical integration of our platform."
NuVasive will have all of the products launched in 2005 on display during its participation in the North American Spine Society's (NASS) 20th Annual Meeting at the Pennsylvania Convention Center in Philadelphia, PA from September 27, 2005 to October 1, 2005. NuVasive's booth number at NASS is #945.
NuVasive is a medical device company focused on the design, development and marketing of products for the surgical treatment of spine disorders. The Company's product portfolio is focused on applications in the over $2 billion U.S. spine fusion market. The Company's current principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery, or MAS(TM), as well as classic fusion implants.
MAS combines three categories of current product offerings -- NeuroVision(R), a proprietary software-driven nerve avoidance system; MaXcess(R), a unique split-blade design retraction system; and specialized implants, like SpheRx(TM) and CoRoent(TM) -- that collectively minimize soft tissue disruption during spine surgery while allowing maximum visualization and surgical reproducibility. NuVasive's classic fusion portfolio is comprised predominantly of proprietary saline packaged bone allografts and internal fixation products. NuVasive also has a robust R&D pipeline emphasizing both MAS and motion preservation products such as Total Disc Replacement (TDR) and a nucleus-like cervical disc replacement.