SAN DIEGO, May 17, 2005 /PRNewswire-FirstCall via COMTEX/ -- NuVasive, Inc. (Nasdaq: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today it has launched the SpheRx(TM) Dual Ball Rod (DBR(TM)) Minimally Disruptive Fixation System for percutaneous posterior spinal fixation.
The SpheRx(TM) DBR(TM) is the latest addition to the Company's MAS(TM) Platform of products and offers spine surgeons a number of clinical and ease- of-use benefits, as well as seamless integration with the Company's NeuroVision(R) Nerve Avoidance System.
The differentiating aspect of the SpheRx(TM) DBR(TM) system is its ability to perform "instrument free" compression. Instrument free compression allows the spine surgeon to easily apply up to 5mm of compression by simply moving the DBR Guides with his hands. This elimination of the need for additional bulky or awkward instruments during compression in spinal fixation surgery is unmatched in the industry today.
SpheRx(TM) DBR(TM) offers maximum overall simplicity of use, keeping with the Company's philosophy of developing breakthrough products based on familiar spine surgery instrumentation. The product design allows for a simple, constrained rod insertion achieved through a dual ball rod with spherical ends, which are geometrically constrained within the DBR Guides during rod insertion, guiding the rod directly and easily into the heads of the pedicle screws. The spherical ends of the rod fit securely within the screws at both ends of the construct with no rod overhang, reducing the incidence of superior facet joint violation and tissue trauma. This unique, secure fit also provides the surgeon total confidence the rod is seated properly in the screws and eliminates the possibility of post-operative rod migration.
SpheRx(TM) DBR(TM) is also designed to be seamlessly integrated with the Company's NeuroVision(R) Nerve Avoidance System. Sequentially dilating insulators allow for dynamic stimulation and nerve monitoring during every step of the procedure, from K-Wire insertion and tapping, to screw insertion and compression.
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "We believe the SpheRx(TM) DBR(TM) is quite possibly the most straightforward minimally disruptive fixation system available today. Surgeon feedback has been excellent and endorses the superiority of the product over what has been available on the market. We are very excited about the launch and believe that the many competitive advantages this new percutaneous pedicle screw offers will drive robust adoption and enhance revenues."
John Regan, M.D., Orthopedic Spine Surgeon, Cedars Sinai Medical Center, said, "Unlike other minimally invasive pedicle screw systems where the smallest amount of compression was difficult to attain, DBR enables needed compression similar to that of open surgery without additional instrumentation."
Frank Phillips, M.D., Professor, Orthopaedic Surgery, Rush University Medical Center, said, "With no rod overhang superiorly or inferiorly the potential for adjacent facet impingement is essentially eliminated."
William Taylor, M.D., Associate Clinical Professor, UCSD Division of Neurosurgery, said, "By constraining the spherical ends of the rods in the guide, rod placement becomes very reproducible and predictable."
We are a medical device company focused on the design, development and marketing of products for the surgical treatment of spine disorders. Our product portfolio is focused on applications in the over $2 billion U.S. spine fusion market. Our current principal product offering includes a minimally disruptive surgical platform that we call 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 our 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. Our classic fusion portfolio is comprised predominantly of proprietary saline packaged bone allografts and metal mesh cages. NuVasive also has a robust R&D pipeline emphasizing both MAS and motion preservation products such as Total Disc Replacement (TDR).
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 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. 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 rapidly changing and competitive nature of the medical device industry, 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 government regulation of medical devices, risks related to NuVasive's ability to effectively manage the growth of its business, risks related to ownership and enforcement of intellectual property rights, NuVasive's ability to successfully develop new products, and other risks and uncertainties more fully described in NuVasive's Annual Report on Form 10-K filed with the Securities and Exchange Commission and NuVasive's Prospectus filed pursuant to Rule 424 under the Securities Act of 1933. NuVasive's public filings with the Securities and Exchange Commission are available at 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: Investors: Kevin C. O'Boyle Stephanie Carrington/Nick Laudico Chief Financial Officer The Ruth Group NuVasive, Inc. 646-536-7017/7030 858-909-1800 firstname.lastname@example.org email@example.com firstname.lastname@example.org
SOURCE NuVasive, Inc.
Kevin C. O'Boyle,
Chief Financial Officer, NuVasive, Inc.,
both of The Ruth Group