SeaSpine Announces Limited Commercial Launch of Skipjack™ Expandable Interbody System
July 13 2017 - 4:05PM
SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical
technology company focused on surgical solutions for the treatment
of spinal disorders, today announced the limited commercial launch
of and completion of initial cases for its Skipjack Expandable
Interbody System.
Skipjack is an expandable interbody system based on patented
technology acquired as part of the NLT transaction announced in
August 2016. Skipjack is designed to provide continuous
in-situ expansion in either height or lordosis for a tailored
anatomical fit. Skipjack adds to SeaSpine’s portfolio of
differentiated solutions within the interbody device market, which
is estimated to be one of the fastest growing segments of the U.S.
spinal instrumentation market. Notably, Skipjack implants
provide up to 20 degrees of lordotic correction from a posterior
approach and are accompanied by integrated graft delivery
instrumentation to post-pack the implant and surrounding disc
space.
“The alpha launch of Skipjack reflects the culmination of our
ability to identify and acquire novel technologies and combine it
with our surgeon-focused development and marketing expertise to
rapidly bring innovative new products to market,” said Keith
Valentine, President and Chief Executive Officer of SeaSpine.
“In surgeon-responsive and rapid fashion, SeaSpine has translated
NLT’s intellectual property into what we believe will be high
clinical-value products that contribute to improving patient
lives.”
Skipjack provides surgeons the ability to place smaller implants
that expand within the interbody space, potentially enabling
smaller incisions and more limited nerve retraction without
sacrificing the advantages of larger, but more disruptive,
implants. This in-situ expansion is intended to reduce tissue
disruption, minimize endplate damage and, thereby, improve patient
outcomes.
“The parallel and lordotic options that Skipjack offers allow me
to expand in-situ for a more patient-specific fit. The
initial stability is excellent and being able to backfill the cage
with the same set of instruments helps simplify the procedure,”
stated Dr. James Brennan, Sentara Virginia Beach
Hospital.
About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology
company focused on the design, development and commercialization of
surgical solutions for the treatment of patients suffering from
spinal disorders. SeaSpine has a comprehensive portfolio of
orthobiologics and spinal instrumentation solutions to meet the
varying combinations of products that neurosurgeons and orthopedic
spine surgeons need to perform fusion procedures on the lumbar,
thoracic and cervical spine. SeaSpine’s orthobiologics products
consist of a broad range of advanced and traditional bone graft
substitutes that are designed to improve bone fusion rates
following a wide range of orthopedic surgeries, including spine,
hip, and extremities procedures. SeaSpine’s spinal instrumentation
portfolio consists of an extensive line of products to facilitate
spinal fusion in minimally invasive surgery (MIS), complex spine,
deformity and degenerative procedures. Expertise in both
orthobiologic sciences and spinal instrumentation product
development allows SeaSpine to offer its surgeon customers a
differentiated portfolio and a complete solution to meet their
fusion requirements. SeaSpine currently markets its products in the
United States and in over 30 countries worldwide.
Forward-Looking Statements
SeaSpine cautions you that statements included in this news
release that are not a description of historical facts are
forward-looking statements that are based on the Company's current
expectations and assumptions. Such forward-looking statements
include, but are not limited to, statements relating to: the design
and other potential benefits of the Skipjack Expandable Interbody
System, including its providing a tailored anatomical fit, its
differentiation and ability to compete in the interbody device
market, its ability to enable smaller incisions, limit nerve
retraction, reduce tissue disruption and minimize endplate damage,
and its clinical value and ability to improve patient lives.
Among the factors that could cause or contribute to material
differences between our actual results and the expectations
indicated by our forward-looking statements are risks and
uncertainties that include, but are not limited to: the fact that
the Skipjack Expandable Interbody System has not been validated
clinically, may not address adequately surgeon requirements, and
may require substantial additional development activities, which
could introduce unexpected expense and delay, including potentially
requiring resubmission of one or more products to FDA for
clearance, which clearance cannot be certain, whether on a timely
basis or at all; surgeons’ willingness to use the Skipjack
Expandable Interbody System; the risk that the Skipjack Expandable
Interbody System may not demonstrate adequate safety or efficacy,
independently or relative to competitive products, to support a
full commercial launch; the risk of supply shortages, including as
a result of our dependence on a limited number of third-party
suppliers for components and raw materials, or otherwise; and other
risks and uncertainties more fully described in our news releases
and periodic filings with the Securities and Exchange Commission.
The Company’s public filings with the Securities and Exchange
Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date when made. SeaSpine
does not intend to revise or update any forward-looking statement
set forth in this news release to reflect events or circumstances
arising after the date hereof, except as may be required by
law.
Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com
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