Alphatec Advances Clinical Distinction With OsseoScrew® Clearance
September 26 2018 - 9:00AM
Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq:
ATEC), a provider of innovative spine surgery solutions with a
mission to improve patient lives through the relentless pursuit of
superior outcomes, today announced that it has received 510(k)
clearance from the U.S. Food & Drug
Administration (FDA) for its OsseoScrew® System, making it
available for clinical use for the first time in the United
States.
"I am exceptionally pleased that OsseoScrew has
been cleared for the U.S. market,” said Pat Miles, Chairman and
Chief Executive Officer. “The system will create new market
opportunities for ATEC by uniquely addressing an unmet need for an
underserved patient population. We are building an organic
innovation machine and today’s announcement represents another
significant step toward creating a clinically distinguished
portfolio.”
The OsseoScrew System
OsseoScrew is a next-generation expandable
pedicle screw system, intended to restore the integrity of the
spinal column in elderly patients with advanced stage tumors
involving the thoracic and lumbar spine. It is designed to be
implanted into the pedicle, then expanded after implantation to
achieve increased screw fixation and reduced post-operative pullout
in bone with poor density. OsseoScrew has been clinically
proven to increase pullout and holding strength, improving fixation
in the bone-implant interface by 29%, as compared to conventional
pedicle screws. It performs comparably to cemented
fenestrated screws without the risk associated with cement
leakage.
Alphatec will display OsseoScrew this week at
the North American Spine Society (NASS) 2018 Annual Meeting, which
is being held from September 26-29 at the Los Angeles Convention
Center.
About Alphatec Holdings,
Inc.
Alphatec Holdings, Inc., through its
wholly-owned subsidiaries, Alphatec Spine,
Inc. and SafeOp Surgical, Inc., is a medical device
company that designs, develops, and markets technology for the
treatment of spinal disorders associated with disease and
degeneration, congenital deformities and trauma. The Company's
mission is to improve lives by providing innovative spine surgery
solutions through the relentless pursuit of superior outcomes. The
Company markets its products in the U.S. via independent sales
agents and a direct sales force.
Alphatec, Alphatec Spine, the Alphatec logo,
SafeOp Surgical and OsseoScrew are trademarks or registered
trademarks of Alphatec Holdings, Inc., its affiliates and/or
subsidiary companies. All other marks are the property of their
owners. Additional information can be found
at www.atecspine.com.
Forward-Looking Statements
This press release contains "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. The Company 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 the references to the
Company’s strategy in significantly repositioning the ATEC brand
and turning the Company into a growth organization. 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 the Company’s pipeline; the uncertainties in the
Company’s ability to execute upon its strategic operating plan; the
uncertainties regarding the ability to successfully license or
acquire new products, and the commercial success of such products;
failure to achieve acceptance of the Company’s products by the
surgeon community, including OsseoScrew, Battalion and Arsenal
Deformity; failure to obtain FDA or other regulatory clearance or
approval for new products, or unexpected or prolonged delays in the
process; continuation of favorable third party reimbursement for
procedures performed using the Company’s products; unanticipated
expenses or liabilities or other adverse events affecting cash flow
or the Company’s ability to successfully control its costs or
achieve profitability; uncertainty of additional funding; the
Company’s ability to compete with other competing products and with
emerging new technologies; product liability exposure; an
unsuccessful outcome in any litigation in which the Company is a
defendant; patent infringement claims; claims related to the
Company’s intellectual property and the Company’s ability to meet
its financial obligations under its credit agreements and the
Orthotec settlement agreement. 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. A further list
and description of these and other factors, risks and uncertainties
can be found in the Company's most recent annual report, and any
subsequent quarterly and current reports, filed with
the Securities and Exchange Commission. ATEC 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.
Investor/Media Contact:Tina JacobsenInvestor
Relationstjacobsen@moreeffectiveir.com
Company Contact:Jeff BlackExecutive Vice
President and Chief Financial OfficerAlphatec Holdings,
Inc.ir@atecspine.com
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