NuVasive(R) Announces First Patient in the United States

NuVasive(R) Announces First Patient in the United States Treated With
the PCM(R) Cervical Disc Following FDA Approval 
SAN DIEGO, CA -- (Marketwire) -- 12/20/12 --  NuVasive, Inc. (NASDAQ:
NUVA), a medical device company focused on developing minimally
disruptive surgical products and procedures for the spine, announced
that Paul Sawin, M.D., performed the first PCM Cervical Disc surgery
on a patient in Orlando, Florida, today. Surgeon proctors, who will
instruct upcoming training courses, have started scheduling surgeries
now that the new device is available. Surgeon demand for training is
strong with courses scheduled to begin next month.  
NuVasive received FDA approval for the PCM Cervical Disc in October
2012 after successful completion of a prospective, multicenter
randomized investigational device exemption (IDE) clinical trial. The
novel device is now being 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.  
Alex Lukianov, Chairman and CEO of NuVasive, said, "We are very
pleased with the initial surgeon interest in this innovative
technology. The first U.S. training courses at the NuVasive East and
West coast-based facilities are solidly booked. The unique nature of
the PCM Cervical Disc and the healthy demand for surgeon training
gives us confidence in our expectation for $3.5 million to $5 million
in related revenue in 2013. The device is a differentiated, game
changing solution for the cervical spine, and marks NuVasive's foray
into an exciting, rapidly growing 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 discectomy 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 biologic 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 NuVasive's revenue or earnings projections may turn out to
be inaccurate because of the preliminary nature of the forecasts and
the risk of further adjustment, or unanticipated difficulty in
selling products or generating expected profitability; 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 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:
Stephan Ogilvie 
VP, Corporate Development & Investor Relations 
NuVasive, Inc.
201-322-6515
investorrelations@nuvasive.com 
Media:
Nicholas S. Laudico
The Ruth Group
646-536-7030
nlaudico@theruthgroup.com