SAN DIEGO, Sept. 26 /PRNewswire-FirstCall/ -- NuVasive, Inc. , a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today the launch of several new products within the Company’s MAS(TM) Platform. The newly launched products include:
Product Category Product(s) Being Launched Access Systems MaXcess(R) III retraction system Instrument Sets Redesigned instrument sets for each of the following lumbar fusion procedures: * ALIF (anterior lumbar interbody fusion) * PLIF (posterior lumbar interbody fusion) * TLIF (transforaminal lumbar interbody fusion * XLIF(R) (eXtreme lateral interbody fusion) Specialized Implants CoRoent(R) LX; CoRoent XL-L; and CoRoent S-L
MaXcess III is a further enhancement of the Company’s MaXcess and MaXcess II systems, with the addition of several features that improve access to the spine. MaXcess III maintains the split-blade design and continues to incorporate the Company’s NeuroVision nerve avoidance technology within the posterior retraction blade. MaXcess III adds a removable fourth blade, which provides greater posterior surgical options and incorporates an improved tilted blade-locking mechanism.
NuVasive also launched a major redesign of its instrument sets for use in all lumbar spine fusion procedures. This significant design and engineering effort has resulted in best-in-class instruments, a simplified ordering structure and more efficient surgery execution. The simplified and logical set configurations have reduced the number of trays required for a specific surgical procedure, thus making ordering easier for hospitals. In our continued focus on Absolute Responsiveness to Customers, the redesigned instrument sets were developed from the Company’s comprehensive understanding of the many surgical nuances specific to each surgeon and were designed to provide seamless utility with all NuVasive lumbar systems.
The Company launched three new CoRoent systems providing surgeons with improved anatomical reconstruction characteristics. All of the systems are radiolucent, giving the surgeon a full view of the patient’s anatomy during surgery and include radio dense titanium markers, enabling the surgeon to visually confirm their correct placement during and after surgery.
The Company has also gained initial clinical experience with the following three products, each of which is scheduled for limited release in the fourth quarter of 2006:
Product Category Product(s) Being Launched Specialized Implants Lateral Lumbar XLIF Plate Nerve Monitoring System NeuroVision(R) enhanced with Motor Evoked Potentials (MEP) capability; and NeuroVision Remote Monitoring(R)
The Lateral Lumbar XLIF Plate is designed for use during the Company’s proprietary XLIF procedure and allows for the placement of a fixation device through the same incision used for placing CoRoent systems. This provides the option to use a plate for fixation through an existing incision rather than utilizing pedicle screws. Planned NeuroVision upgrades now incorporate MEP technology for complete monitoring of nerve activity in the thoracic and cervical regions of the spine. The system also includes numerous software upgrades, providing enhanced user interface. In addition, the Company plans to launch NeuroVision upgrades allowing for Remote Monitoring, providing surgeons the ability to monitor surgeries both intraoperatively and remotely, allowing for greater case coverage.
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, “The launch of these new products maintains our position at the forefront introducing innovative minimally disruptive spine surgery technologies. We are particularly excited about our MaXcess III retractor. We believe the enhanced features of this retractor provide surgeons with the maximum amount of access to the patient’s spine in a safe and reproducible minimally disruptive procedure. We expect that this product will continue to stimulate increased use of our innovative implants. Our instrument set redesign, along with our recently announced Memphis distribution facility, will provide increased speed of delivery to surgeons and unparalleled efficiency to our sales force.”
Mr. Lukianov continued, “Our exclusive sales force continues to gain momentum incorporating our full product line into their territories and achieving deeper penetration into hospitals. We continue to believe the combination of this strengthened sales force and our focus on developing innovative products will translate into robust long-term revenue growth.”
The Gradient Plus(TM) Cervical Plate System was launched in March of 2006 and offers maximum intraoperative flexibility by providing surgeons with a choice of fixed, semi-constrained and dynamic constructs in one system. Together with the product releases announced today and the releases scheduled for the fourth quarter of 2006, this will complete the Company’s nine planned product launches for 2006.
NuVasive will have all aforementioned products on display during its participation in the North American Spine Society’s (NASS) 21st Annual Meeting at the Washington State Convention Center in Seattle, WA from September 26, 2006 to September 30, 2006. NuVasive’s booth number at NASS is #1830.
About NuVasive
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 $2.9 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(R) and CoRoent(R) -- 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.
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: the risk that NuVasive’s revenue projections may turn out to be incorrect because of unanticipated difficulty in selling products; the uncertain process of seeking regulatory approval or clearance for NuVasive’s products or devices, 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; the risk that additional clinical data may call into question the benefits of NuVasive’s products to patients, hospitals and surgeons; 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.
Contact: Investors: Kevin C. O’Boyle Carol Ruth/Nick Laudico EVP & Chief Financial Officer The Ruth Group NuVasive, Inc. 646-536-7004/7030 858-909-1800 cruth@theruthgroup.cominvestorrelations@nuvasive.comnlaudico@theruthgroup.com
NuVasive, Inc.
CONTACT: Kevin C. O’Boyle, EVP & Chief Financial Officer of NuVasive,Inc., +1-858-909-1800, investorrelations@nuvasive.com; or Investors - CarolRuth, +1-646-536-7004, cruth@theruthgroup.com, or Nick Laudico,+1-646-536-7030, nlaudico@theruthgroup.com, both of The Ruth Group
Web site: http://www.nuvasive.com/
