Healthcare Industry News: MaXcess
News Release - September 18, 2006
NuVasive Treats First Patient with NeoDisc(TM)SAN DIEGO, Sept. 18 (HSMN NewsFeed) -- NuVasive, Inc. (Nasdaq: NUVA ), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today the first-in-human U.S. use of its NeoDisc cervical disc replacement device. The first procedure is part of a prospective, randomized, controlled, multi-center clinical trial to evaluate the safety and efficacy of NeoDisc by comparing the outcomes of patients to traditional anterior cervical discectomy and fusion. This first implantation is ahead of the company's guidance to begin enrollment by the fourth quarter.
The first patient was treated at the Central Texas Spine Institute in Austin, Texas by Dr. Randall Dryer, Orthopedic Surgeon, on Friday, September 15, 2006.
Dr. Randall Dryer, said, "NeoDisc is truly a next generation cervical disc replacement device. Unlike most mechanical disc replacement devices, it spares the vertebral endplates and offers a more forgiving placement, while providing continued motion for the spine. The procedure is extremely straightforward and will be familiar to any surgeon who has performed cervical fusion. I am pleased to say that the patient recovered rapidly from the procedure and was discharged after an overnight stay." When compared to a traditional cervical fusion with anterior plating Dr. Dryer stated, "The procedure can be performed more quickly because it requires less technical steps."
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "We are excited to have the NeoDisc clinical trial underway, as it marks the first step in our strategy to address the cervical motion preservation market. We believe that retaining natural motion is key to positive long term surgical outcomes in the neck, and the full imaging capability afforded by the NeoDisc enables increased verification of surgical goals. We also believe that highly revisable procedures, such as that afforded by NeoDisc, represent the most substantial opportunity to address degenerative disc disease with early intervention while allowing for spinal motion. These attributes make NeoDisc one of the most innovative spinal motion preservation products under development."
The clinical trial to evaluate Neodisc includes a total patient population of approximately 500 across an estimated 20 clinical investigation sites. The Company's Gradient Plus(TM) cervical plate in a fusion procedure will serve as the control arm and the full enrollment timeframe is estimated to be between 12 and 18 months.
NeoDisc is designed to treat patients earlier in the degenerative cascade, prior to a fusion procedure, and to be imaging friendly (radiolucent) and fully revisable. It is designed to safely replace a degenerative cervical disc nucleus, partial annulus and anterior longitudinal ligament, while maintaining range of motion and leaving the natural vertebral endplates intact. Its unique design of an embroidered polyester jacket, surrounding a silicone core, with fixation flanges lends itself to these goals in an optimal fashion.
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®, a proprietary software-driven nerve avoidance system; MaXcess®, a unique split-blade design retraction system; and specialized implants, like SpheRx® and CoRoent® -- 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 uncertain patient outcomes from the NeoDisc clinical trial currently underway, including the risk that such results may not demonstrate Neodisc as safe and effective; 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 (including NeoDisc); 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 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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