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, announced today the first clinical use
of Alphatec NEXoss, a next generation synthetic bone graft
indicated for use in posterolateral spine fusions in conjunction
with bone marrow aspirate, autograft bone and appropriate hardware.
Alphatec NEXoss is composed of two unique patented technologies.
The first is an engineered extracellular collagen bioscaffold that
provides a physical structure for cell infiltration and attachment.
The second is osteoconductive nano-structured bone crystals that
have similar composition, structure and size as human bone. These
two technologies function together to provide an ideal environment
for a natural bone growth solution. Alphatec NEXoss is supported by
in vitro and in vivo clinical data.
Last month, Alphatec announced the acquisition of exclusive U.S.
distribution rights to market the product under its own brand name
called Alphatec NEXoss. Alphatec NEXoss is FDA-cleared for
commercial sale.
The three-level posterior lumbar fusion procedure was performed
by Joseph Stern, M.D., a neurosurgeon in private practice in
Greensboro, NC. The patient was treated for progressive worsening
of spondylolisthesis of L3-4 and L5-S1 with spinal stenosis and
degenerative changes at L3-4, L4-5, and L5-S1 levels.
Dr. Stern chose Alphatec NEXoss as the fusion graft material
based on the proven safety and effectiveness of the product
technology. "I am very pleased with the excellent handling
properties of Alphatec NEXoss," said Dr. Stern. The mixing and
delivery system has been designed with the surgeon in mind and
provides a very easy and effective way to deliver the graft both in
open and MIS cases."
"Alphatec NEXoss is an excellent product and an important
addition that strengthens our biologics portfolio with a synthetic
bone matrix offering," said Les Cross, Alphatec Spine's Chairman
and Chief Executive Officer. "What makes NEXoss effective is that
its patented structure is nearly identical in composition to
natural human bone.
"Having a synthetic bone graft solution enables Alphatec Spine
to offer one of the most comprehensive biologics portfolios in the
industry, which includes structural allografts, DBMs, scar
barriers, a stem cell allograft and now synthetic bone grafts. In
addition to the many internal new product development programs we
have underway, this supply agreement is representative of the many
opportunities available in the marketplace today that will help the
Company maintain a continuous flow of new products."
Many surgical procedures of the spine require bone grafts to
regenerate bone that has been removed or damaged due to disease or
trauma. The current "gold standard" for bone grafting incorporates
an autograft of bone harvested from the patient's iliac crest.
Although considered the gold standard, use of autograft is not
without its significant disadvantages. In addition to the need for
a second operation to harvest the bone from the iliac crest, the
supply of harvested autograft is limited and the patient may
experience significant post-operative pain at the harvest site for
an extended period of time.
A second type of bone used in grafting procedures uses allograft
bone derived from processed human cadaver bone. While allograft
bone has been used for many years, it also has some disadvantages
in that the risk of disease transmission can never be completely
ruled out.
The newest technological development for bone grafting products
includes synthetic materials. Alphatec NEXoss is an advanced
bone graft combining an engineered extracellular matrix bioscaffold
proven as an ideal pathway for cell infiltration and
osteoconductive nano-structured crystals that mimic the
composition, structure and size of human bone, providing a natural
bone growth solution.
The spinal orthobiologics market is estimated to be
approximately $2 billion annually in the U.S. Synthetics are one of
the fastest growing markets in the spinal orthobiologics space and
are expected to grow at a compound annual growth rate of
approximately 10% over the next 5 years. (Source: i-Data)
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, with respect to the agreement
described in this press release, references to the size of the
market for spinal orthobiologics and the adoption rate of the
product by U.S. spinal surgeons. In addition, forward-looking
statements include the Company's ability to develop and
commercialize new products internally, and its ability to
successfully pursue and commercialize complementary acquisitions of
new products and technologies. 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 product
discussed in this press release; failure to achieve acceptance of
Alphatec Spine's products by the surgeon community; 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 FDA clearance or
approval for products, including the product 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 for the year ended December 31, 2011 filed on
March 5, 2012 with the Securities and Exchange Commission, 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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