Alphatec Spine Receives U.S. FDA 510(K) Market Clearance for Two New Products and Receives Japanese Shonin Approval to Begin Ma
03 Janvier 2013 - 1:35PM
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of
Alphatec Spine, Inc., a medical device company that designs,
develops, manufactures and markets products for the surgical
treatment of spine disorders, with a focus on treating conditions
related to the aging spine, today provided an update related to its
product commercialization efforts.
The Company announced that it has recently received 510(k)
market clearance from the U.S. Food and Drug Administration (FDA)
for two new products in the Company's new product pipeline:
- An anchored, anterior cervical interbody device, called
Pegasus™, which offers single-step deployment of the anchoring
blades without the need for impaction; and,
- A new MIS system, called ILLICO® FS Facet Fixation System,
which enables spine surgeons to immobilize and stabilize spinal
segments without the need for pedicle screw and rod
constructs.
Additionally, the Company said that it has received Shonin
approval in Japan from the Pharmaceuticals and Medical Devices
Agency to market and sell three lines of the Company's Novel PEEK
Spinal Spacers, including the Novel SD, the Novel LCC and the Novel
TL, which are used in posterior spine fusion procedures. PEEK, or
polyetheretherketone, is a radiolucent material containing
radiographic markers, which enhance interbody visualization and
alignment during the fusion process.
"I am pleased to announce these important new developments
related to our new product commercialization strategy at Alphatec
Spine," said Les Cross, Chairman and CEO of Alphatec Spine. Our
initiatives to strengthen the top-line growth of the Company
through robust internal product development, acquisitions and
license arrangements, and continued global expansion are gaining
momentum. Our new Pegasus anchored cervical interbody device and
ILLICO FS system represent key additions to our cervical and MIS
offerings in the U.S., respectively.
"In Japan, product registration has been a long and complex
process and we are pleased to have achieved that significant
milestone for our Novel PEEK Spinal Spacer Systems, complementing
the strong sales presence we have already established there."
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec
Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device
company that designs, develops, manufactures and markets products
for the surgical treatment of spine disorders, primarily focused on
the aging spine. The Company's mission is to combine world-class
customer service with innovative, surgeon-driven products that will
help improve the aging patient's quality of life. The Company
is poised to achieve its goal through new solutions for patients
with osteoporosis, stenosis and other aging spine deformities,
improved minimally invasive products and techniques and integrated
biologics solutions. In addition to its U.S. operations, the
Company also markets its products in over 50 international markets
through its affiliate, Scient'x S.A.S., via a direct sales force in
France, Italy and the United Kingdom and via independent
distributors in the rest of Europe, the Middle East and Africa. In
Latin America, the Company conducts its business through its
subsidiary, Cibramed Produtos Medicos. In Japan, the Company
markets its products through its subsidiary, Alphatec Pacific,
Inc. In the rest of Asia and Australia, the Company sells its
and Scient'x's products through its and Scient'x's
distributors.
The Alphatec Holdings, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3520
Forward Looking Statements
This press release may contain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 that involve risks and uncertainty. Such statements are
based on management's current expectations and are subject to a
number of risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. Alphatec Spine cautions investors that there can be no
assurance that actual results or business conditions will not
differ materially from those projected or suggested in such
forward-looking statements as a result of various factors.
Forward-looking statements include references to the Company's
ability to develop and commercialize new products targeted for U.S.
and international markets. The words "believe," "will,"
"should," "expect," "intend," "estimate" and "anticipate,"
variations of such words and similar expressions identify
forward-looking statements, but their absence does not mean that a
statement is not a forward-looking statement. The important
factors that could cause actual operating results to differ
significantly from those expressed or implied by such
forward-looking statements include, but are not limited to; the
uncertainty of success in developing new products or products
currently in Alphatec Spine's pipeline; the uncertainty of success
in acquiring new products or technologies; the successful launch of
the Company's new products and the products in its development
pipeline, including the products discussed in this press release;
failure to achieve acceptance of Alphatec Spine's products by the
surgeon community, including the products discussed in this press
release; failure to successfully implement streamlining activities
to create operating cost savings; failure to successfully begin
in-house manufacturing of certain products; failure to obtain or
maintain regulatory clearance or approval for products, including
the products discussed in this press release, or unexpected or
prolonged delays in the process; Alphatec Spine's ability to
develop and expand its U.S. and/or global revenues; continuation of
favorable third party payor reimbursement for procedures performed
using Alphatec Spine's products; unanticipated expenses or
liabilities or other adverse events affecting cash flow or Alphatec
Spine's ability to successfully control its costs or achieve
profitability; uncertainty of additional funding; Alphatec Spine's
ability to compete with other competing products and with emerging
new technologies; product liability exposure; failure to meet all
financial obligations in the Cross Medical Settlement; patent
infringement claims and claims related to Alphatec Spine's
intellectual property. Please refer to the risks detailed from time
to time in Alphatec Spine's SEC reports, including its Annual
Report Form 10-K, as well as other filings on Form 10-Q and
periodic filings on Form 8-K. Alphatec Spine disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise, unless required by law.
CONTACT: Investor/Media Contact:
Mark Francois
Senior Director, Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
mfrancois@alphatecspine.com
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