NuVasive Announces PMA Approval of the PCM(R) Cervical Disc

NuVasive Announces PMA Approval of the PCM(R) Cervical Disc System 
SAN DIEGO, CA -- (Marketwire) -- 10/26/12 --  NuVasive, Inc. (NASDAQ:
NUVA), a medical device company focused on developing minimally
disruptive surgical products and procedures for the spine, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Premarket Approval (PMA) for the PCM(R) Cervical Disc System. 
This novel device will be provided to patients and surgeons in the
United States as an innovative option to preserve motion in the
cervical spine instead of a traditional, motion-eliminating fusion
procedure. The FDA approval comes after successful completion of a
prospective, multicenter randomized investigational device exemption
(IDE) clinical trial that was conducted at 23 investigational sites
across the United States and included 403 total treated patients.  
Alex Lukianov, Chairman and Chief Executive Officer, said, "We are
really pleased to offer this unique technology to the U.S. surgical
and patient community. The PCM Cervical Disc is a game changing
solution for the cervical spine, and marks our foray into an exciting
market. This device has many design considerations that make it a
truly unique product offering compared to other cervical motion
preserving devices. Its low-profile design enables it to be minimally
disruptive to the adjacent anatomy and a viable treatment option for
levels adjacent to prior fusions."  
Laetitia Cousin, Vice President of Regulatory and Clinical Affairs at
NuVasive, said, "The strong clinical data speaks for itself and makes
our monumental effort to gain this PMA approval well worth it. In
keeping with the NuVasive philosophy to promote science and
education, our investigators have contributed over 17 peer-reviewed
publications on the PCM Cervical Disc in internationally recognized
journals. I am exceptionally proud of the surgeons, clinical research
staff, patients, and dedicated NuVasive shareowners that contributed
to the advancement of science through the IDE trial and helped to
bring this device to market." 
About the PCM Cervical Disc 
The PCM Cervical Disc is indicated for use in skeletally mature
patients for reconstruction of a degenerated cervical disc at one
level from C3-C4 to C6-C7 following single level disce
ctomy for
intractable radiculopathy (arm pain and/or a neurological deficit),
with or without neck pain, or myelopathy due to a single-level
abnormality localized to the disc space and manifested by at least
one of the following conditions confirmed by radiographic imaging
(CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined
by the presence of osteophytes), and/or visible loss of disc height
as compared to adjacent levels. The device is implanted using an
anterior approach. Patients should have failed at least 6 weeks of
conservative treatment prior to implantation. 
The PCM Cervical Disc is composed of cobalt chrome endplates and a
central polyethylene core, materials that have a long and
well-studied history of use in other orthopedic joint replacements.
The broad radius of the polyethylene core allows for unconstrained
motion preservation and a broad radius of articulation for coupled
motion. The device features a wide footprint to take advantage of the
most stable portions of patients' cervical vertebral bodies and
offers three different footprint and height options. The superior and
inferior endplates also feature three rows of "V-Teeth" which provide
short-term fixation until long-term fixation can occur to anchor our
motion preserving device. 
About NuVasive 
NuVasive is a medical device company focused on developing minimally
disruptive surgical products and procedurally integrated solutions
for the spine. The Company is the 4th largest player in the $7.9
billion global spine market. 
NuVasive's principal product offering is based on its Maximum Access
Surgery, or MAS(R) platform. The MAS platform combines several
categories of solutions that collectively minimize soft tissue
disruption during spine surgery with maximum visualization and safe,
easy reproducibility for the surgeon: a proprietary software-driven
nerve avoidance system and intra-operative monitoring support;
MaXcess(R), a unique split-blade retractor system; a wide variety of
specialized implants; and several biologic fusion enhancers. MAS
significantly reduces surgery time and returns patients to activities
of daily living much faster than conventional approaches. Having
redefined spine surgery with the MAS platform's lateral approach,
known as eXtreme Lateral Interbody Fusion, or XLIF(R), NuVasive has
built an entire spine franchise. With over 75 products today spanning
lumbar, thoracic and cervical applications, the Company will continue
to expand and evolve its offering predicated on its R&D focus and
dedication to outstanding service levels supported by a culture of
Absolute Responsiveness(R).  
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 spine surgeons may be slow to adopt the PCM Cervical Disc
System or our other products; the risk that future patient studies or
clinical experience may indicate that treatment with the PCM Cervical
Disc System or our other products does not improve patient outcomes;
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 insurance payers may
refuse to reimburse healthcare providers for the use of NuVasive's
products 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. 
Contact: 
Michael J. Lambert 
EVP & Chief Financial Officer 
NuVasive, Inc. 
858-909-3394 
investorrelations@nuvasive.com  
Investors:
Patrick F. Williams 
Vice President, Strategy & Investor Relations
NuVasive, Inc.
858-638-5511
investorrelations@nuvasive.com 
Media: 
Nicholas S. Laudico
The Ruth Group
646-536-7030
nlaudico@theruthgroup.com 
 
 
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