SAN DIEGO, April 22 /PRNewswire-FirstCall/ -- NuVasive, Inc. (Nasdaq:
NUVA), a medical device company focused on developing products for minimally
disruptive surgical treatments for the spine, announced today that it has
agreed to purchase Cervitech(R) Inc., a New Jersey based company focused on
clinical approval of the PCM(R) cervical disc system, a motion preserving
total disc replacement device. This strategic acquisition allows NuVasive the
potential to accelerate its entry into the growing mechanical cervical disc
replacement market.
Alex Lukianov, Chairman and CEO of NuVasive said, "We believe that the
cervical disc replacement market will become one of the fastest growing
segments in spine over the next several years as surgeons and patients choose
motion preservation over traditional fusion. The PCM investigational device
has the potential to significantly accelerate NuVasive's entry into this
important market. Cervitech is running an impressive clinical trial and the
published clinical data verifies that the PCM offers significant benefits to
patients. The potential approval will further strengthen our cervical
product offering and will enable us to continue our trend of taking market
share."
Massimo Calafiore, President of Cervitech Inc. said, "We are very pleased
to have NuVasive continue the development of the PCM. We thank all those whose
efforts have brought Cervitech to this point and we look forward to NuVasive's
commercial success with the device."
Currently, the PCM investigational device is in an FDA-approved clinical
trial in the United States and two year follow up is scheduled to be completed
in the fourth quarter of 2009. NuVasive anticipates submitting for FDA
approval in the first quarter of 2010. The Company expects modest sales
outside the U.S. in the near term, with product revenue of $100 million
annually within three years of U.S. commercialization.
The initial payment for purchase of Cervitech will be approximately $47
million, with an additional contingent payment of $33 million upon FDA
approval of the device. At NuVasive's discretion, all payments may be made in
up to 50 percent NuVasive stock. The transaction will be dilutive in 2009,
but the Company expects to absorb any dilutive effects in its operations as
indicated by the increased guidance detailed in today's first quarter 2009
earnings release.
Additional Information on PCM® Acquisition
PCM® Clinical Data:
Cervical Disc Replacement in Patients With and Without Previous Adjacent Level Fusion Surgery: A Prospective Study
Superiority of Multilevel Cervical Arthroplasty Outcomes Versus Single-Level Outcomes: 229 Consecutive PCM Prostheses
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 primarily on the $4.6 billion U.S.
spine implant market. Additionally, the Company has expanded into the $1.5
billion global biologics market, the $1.5 billion international market, and
is developing products for the emerging motion preservation market.
NuVasive's principal product offering is based on its Maximum Access
Surgery, or MAS(R) platform. The MAS platform combines four categories of
products that collectively minimize soft tissue disruption during spine
surgery with maximum visualization and safe, easy reproducibility for the
surgeon: NeuroVision(R), a proprietary software-driven nerve avoidance system;
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 nearly 50 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,
relative to the proposed acquisition, include, but are not limited to: the
risk that the parties may not consummate the transaction in the expected
timeframe or that intervening factors may cause the parties to alter the terms
(financial or otherwise)of the transaction; the risk that NuVasive may not be
able to achieve expected synergies and strategic benefits from the technology
owned by the acquired company; and the risk that NuVasive will not be able to
successfully integrate the operations of the acquired company. 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 the Company's financial
projections may prove incorrect because of unexpected difficulty in generating
sales or achieving anticipated profitability; 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: Investors:
Kevin C. O'BoylePatrick F. Williams
EVP & Chief Financial Officer Vice President, Finance
NuVasive, Inc. & Investor Relations
858-909-1998 NuVasive, Inc.investorrelations@nuvasive.com 858-638-5511
investorrelations@nuvasive.com
Media:
Jason RandoThe Ruth Group
646-536-7025
jrando@theruthgroup.com
SOURCE NuVasive, Inc.
04/22/2009
CONTACT: Kevin C. O'Boyle, EVP & Chief Financial Officer,
+1-858-909-1998, investorrelations@nuvasive.com, or Investors, Patrick F.
Williams, Vice President, Finance & Investor Relations, +1-858-638-5511,
investorrelations@nuvasive.com, both of NuVasive, Inc.; or Media, Jason Rando
of The Ruth Group, +1-646-536-7025, jrando@theruthgroup.com
Web Site: http://www.nuvasive.com