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.
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 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
sec. NuVasive assumes no obligation to update any forward-looking
statement to reflect events or circumstances arising after the date on
which it was made.
NuVasive, Inc.
nuvasive
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