SAN DIEGO, Aug. 11 /PRNewswire-FirstCall/ -- 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 the Insulated Pedicle Access System, or I-PAS(TM), a surgical instrument used to determine the safe percutaneous approach pathway of a pedicle screw prior to its implantation.
I-PAS is designed to be used in conjunction with the Company's NeuroVision(R) nerve avoidance software to dynamically test the percutaneous approach of a pedicle screw prior to its implantation into the vertebral body. Performing a dynamic test provides the surgeon with constant feedback about the proximity of surrounding nerves in the screw's pathway, allowing its safe approach into the vertebral body and avoiding a potential breach of the pedicle wall. Once safely in the pedicle, a guide wire is placed through the needle to allow a subsequent implant, such as the Company's SpheRx(TM) DBR(TM), to pass safely over the guide wire into the pedicle. This is the first percutaneous and dynamic neurophysiologic system on the market to continuously monitor and alleviate the risk of neurological injury. This added detection offered by I-PAS also allows for less fluoroscopy during the surgery, which is beneficial to both surgeon and patient.
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "The ability to dynamically test for surrounding nerves from the spinal access needle prior to screw placement is a feature unique to our percutaneous I-PAS Insulated Pedicle Access System. We believe I-PAS provides surgeons with a substantial tool to increase the safety of the procedure while adding intra-operative efficiency. The launch of I-PAS is consistent with our vertical integration strategy of providing products that increase penetration of our MAS(TM) platform among spine surgeons. This is the fourth new product launch in 2005 and we remain on track with our planned nine total product launches for 2005."
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.
NuVasive cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties that could cause actual growth and results to differ materially include, but are not limited to: risks that additional clinical experience may demonstrate that NuVasive's products or proprietary procedures do not provide the intended safe and reproducible results; the risk that NuVasive's competitors may develop comparable or superior products or technologies; NuVasive's ability to convince surgeons to use its products; the ability of patients to obtain third-party reimbursement for surgical procedures employing NuVasive's products; risks related to NuVasive's ability to effectively manage the growth of its business and expansion of its product line; NuVasive's ability to successfully develop and commercialize new products and technologies; and other risks and uncertainties more fully described in NuVasive's press releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at http://www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.
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