SAN DIEGO, July 6 /PRNewswire-FirstCall/ -- NuVasive, Inc. (Nasdaq: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that it filed for an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to investigate the safety and efficacy of its Cerpass (TM) cervical Total Disc Replacement (TDR) product on June 30, 2005 as planned. Approval of the IDE from the FDA would allow the Company to initiate a pivotal human clinical study of the device in the U.S.
TDR replaces a damaged or degenerative diseased spinal disc and allows for flexibility in that space by retaining the normal biomechanics of the spine and preserving natural range of motion versus the traditional fusion procedures which replace the disc with implants that bridge the space and facilitate new bone growth to eliminate motion.
NuVasive's Cerpass (TM) cervical TDR product incorporates a ceramic-on-ceramic design that the Company believes increases durability and eliminates the potential problems of wear debris from other bearing surfaces such as polyethylene. In pre-clinical testing, the Cerpass (TM) compared favorably to other artificial spinal discs currently in FDA clinical studies. Cerpass (TM) is also designed to ensure proper placement because of its "self-centering" feature. Cerpass (TM) is designed for implantation through an anterior approach to the cervical region of the spine (front of the neck).
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "The IDE filing for U.S. clinical trials of our Cerpass (TM) cervical TDR product represents a major milestone in NuVasive's artificial disc development efforts for motion preservation of the neck vertebrae. We believe the ceramic-on-ceramic design will achieve superior long-term wear characteristics compared to that of other bearing surfaces. Our initial TDR focus continues to be on the cervical region of the spine. We believe it offers a more substantial market opportunity and will experience a broader, more rapid adoption by spine surgeons particularly when coupled with our "self-centering" feature to simplify implantation. We plan to discuss the details of the FDA study for our Cerpass (TM) following IDE approval."
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.
The MAS platform offers advantages for both patients and surgeons such as reduced surgery and hospitalization time and faster recovery. 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).
NuVasive cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements 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. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. The potential risks and uncertainties that could cause actual growth and results to differ materially include, but are not limited to, the process of seeking regulatory approval or clearance for NuVasive's products, including risks that such process could be significantly delayed; the possibility that the FDA may require significant changes to NuVasive's products or clinical studies; the risk that products may not perform as intended and may therefore not achieve commercial success; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; risks associated with changing market dynamics and opportunities in the fast-growing spine industry; and other risks and uncertainties more fully described in NuVasive's 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.
CONTACT: Kevin C. O'Boyle, EVP & Chief Financial Officer, NuVasive, Inc., +1-858-909-1800, firstname.lastname@example.org; or Investors, Stephanie Carrington, +1-646-536-7017, email@example.com, or Nick Laudico, +1-646-536-7030, firstname.lastname@example.org, both of The Ruth Group for NuVasive, Inc.
Kevin C. O'Boyle,
EVP & Chief Financial Officer, NuVasive, Inc.,
both of The Ruth Group for NuVasive, Inc.