Healthcare Industry News: cervical spine
News Release - June 28, 2006
NuVasive Announces IDE Approval to Begin NeoDisc(TM) Pivotal TrialSAN DIEGO, June 28 (HSMN NewsFeed) -- NuVasive, Inc. (Nasdaq: NUVA ), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin clinical trial enrollment of its NeoDisc cervical disc replacement device.
The clinical trial is a prospective, randomized, controlled, multi-center trial to evaluate the safety and efficacy of NeoDisc by comparing the outcomes of patients to traditional anterior cervical discectomy and fusion. The Company expects to begin enrolling patients in the trial by the fourth quarter of 2006 with a follow-up period of two years.
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "We are extremely encouraged with the approval of an IDE for NeoDisc and look forward to the long-term data this study will provide. Having a product that is a first option device that preserves motion and can be fully revised to other cervical procedures is a significant advancement in cervical spine surgery technology. It is clear that the future of minimally disruptive cervical spine surgery lies with both fusion and the ability to relieve pain while preserving motion and minimizing stress to adjacent discs. We believe that NeoDisc represents one of the most innovative spinal motion preservation products under development. Our strategy remains to focus on the cervical motion preservation market first, followed by lateral lumbar disc replacement, as we believe the cervical market presents a greater market opportunity."
The most common form of surgery for treating cervical degenerative disc disease is cervical spinal fusion, which is intended to relieve an impingement on the spinal cord or nerve root and relieve associated arm and/or neck pain. In a cervical spine fusion procedure, the degenerated disc is removed, an interbody implant is inserted in its place, and a metal plate is then implanted to fuse the cervical vertebrae together.
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.
NuVasive believes NeoDisc is unique in that it replicates the motion characteristics of an intact healthy cervical intervertebral disc while minimizing the disruption to native surrounding structures in the cervical spine. Its elastomer core mimics the loading characteristics of an intact nucleus, creating a reconstruction that may act in a manner more similar to the natural mechanics of the intervertebral disc than articulating bearing (ball and trough) disc replacement devices. Its embroidered polyester annular jacket with anterior fixation flanges envelopes the core and fixates the device to the anterior surface of the spine. The embroidered polyester material is designed to act as a scaffold for soft tissue ingrowth.
To participate in the clinical trial, all potential patients are subject to strict selection criteria. These criteria are not fully listed below. Some of the key criteria are outlined as follows:
-- 18-60 years of age
-- A diagnosis of symptomatic cervical disc disease
-- Exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal nerve sensitivity, or pain in a nerve distribution -- Symptomatic level is at one level
-- Unresponsive to conservative treatment for 6 weeks or longer, or
exhibits progressive symptoms or signs of nerve root or spinal cord compression in the face of conservative treatment
-- No prior cervical fusion surgery at the operative level
Patients enrolled in the study must be evaluated by their surgeon at regular intervals for a minimum of two years following the surgery. The NeoDisc is an investigational device and has been through only limited pre-clinical evaluation and is not approved for sale in the United States.
The company will provide additional information regarding the NeoDisc clinical study during its earnings release conference call on Thursday, July 27, 2006 at 2:30pm pacific/5:30pm eastern.
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 such as Total Disc Replacement (TDR) and the NeoDisc investigational device.
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 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 additional clinical data may call into question the benefits of NuVasive's products or investigational devices (including NeoDisc) to patients, hospitals and surgeons, or demonstrate that NuVasive's products and procedures do not provide meaningful cost savings; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; 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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