Alphatec’s Arsenal™ Deformity Adolescent Scoliosis (AIS) System Launched in Limited Markets in the U.S.
28 Februar 2017 - 10:37PM
Alphatec Spine, Inc., (Nasdaq:ATEC), a global provider of spinal
fusion technologies, announced today that the Company has launched
its new Arsenal Deformity Adolescent Idiopathic Scoliosis (AIS)
System and has successfully completed initial patient cases.
The limited release further expands the Company’s Arsenal Spinal
Fixation System and targets the $650M U.S. deformity spine
market.
The Arsenal AIS System gives surgeons a complete solution to
address complex deformity pathologies, including unique uniplanar
screws, which enable easier screw positioning and rod placement
through a tulip that has 360 degrees of rotation, while restricting
motion in the medial/lateral plane for derotation correction.
Additionally, the AIS system includes a wide variety of low-profile
implants providing a better anatomical fit and increased ability to
address patient pathologies, ergonomically designed instrumentation
to improve surgical efficiency and comfort during complex
surgeries, and proven biomechanical strength necessary to achieve a
solid fusion.
Terry Rich, Alphatec Spine’s Chief Executive Officer commented,
“With the launch of our differentiated AIS Deformity System we are
able to compete directly with the market leaders in complex spine
and it opens up a new segment for us in pediatric procedures.
This unique system extends our Arsenal platform and provides
surgeons with easy-to-use, differentiated surgical tools for
corrective maneuvers to better treat adolescent patients who are
diagnosed with idiopathic scoliosis. These successful initial
patient cases demonstrate ATEC’s ongoing commitment to developing
innovative solutions that are targeted at improving overall patient
outcomes and surgeon experience. The Arsenal AIS system gives
us the opportunity to gain greater share in the deformity market
and to benefit a vast number patients who are suffering today.”
Dr. Sheldon St. Clair, a pediatric orthopedic surgeon, and Dr.
John Birknes, a pediatric neurosurgeon, co-directors of the
Spine Program at the Children's Hospital of the King’s
Daughters in Virginia, have partnered to treat pediatric spine
deformities and performed the first deformity correction using the
Arsenal AIS system. The patient was a skeletally immature
13-year-old with a hypokyphotic 49-degree thoracic scoliosis.
Drs. St. Clair and Birknes performed the surgery using the Arsenal
uniplanar implants and cobalt-chromium alloy rods on a long
construct across 9 levels from thoracic vertebrae T3 to T12.
Post-surgery, the patient’s thoracic curve has been eliminated,
appropriate kyphosis has been restored, and the patient’s rib hump
is no longer present.
“The entire Arsenal Deformity AIS set is fantastic, but the
shining star is the ability to spin the uniplanar bodies
independent of the screw shank, which allows surgeons to achieve
optimal fixation and placement of the pedicle screws,” said Dr. St.
Clair. “This unique feature enables the tulips to be placed at the
perfect height and orientation to accept the rod and correct the
deformity. The slotted reduction towers are used both to
reduce the rod into the tulips as well as to perform vertebral
column manipulation to correct the spine in three planes of
deformity. The reduction towers and transverse links
are designed to be attached and removed with ease.
The Arsenal AIS system provides strong, reliable
implants, and two choices of cobalt chrome rods, enabling the
surgeon to obtain excellent spinal deformity correction, which
improves quality of life for the patient both now and for the
future.”
About Alphatec Spine
Alphatec Spine, Inc., a wholly owned subsidiary
of Alphatec Holdings, Inc. (Nasdaq:ATEC), is a medical device
company that designs, develops, manufactures and markets spinal
fusion technology products and solutions for the treatment of
spinal disorders associated with disease and degeneration,
congenital deformities and trauma. The Company's mission is to
improve lives by delivering advancements in spinal fusion
technologies. The Company and its affiliates market products in the
U.S. via a direct sales force and independent distributors.
Additional information can be found at
www.alphatecspine.com.
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 the Company's
ability to achieve profitable growth; the Company’s ability to
achieve both domestic and international growth and future
profitability. 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
within forecast timeframes, or at all, including without limitation
the products discussed in this press release; the Company’s ability
to compete directly with the market leaders in complex spine and
open up a new segment for the Company in pediatric procedures; the
Company’s ability to gain greater share in the deformity market and
to benefit a vast number patients in such market; the acceptance of
Alphatec Spine's products by the surgeon community, including
without limitation the products discussed in this press
release; and Alphatec Spine's ability to develop and expand
its U.S. revenues. 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:
Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com
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