SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh
November 30 2017 - 8:30AM
SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical
technology company focused on surgical solutions for the treatment
of spinal disorders, today announced that it has received 510(k)
clearance from the United States Food and Drug Administration (FDA)
for use of its OsteoBallast™ Demineralized Bone Matrix (DBM) in
Resorbable Mesh.
The OsteoBallast product is the latest innovation in SeaSpine’s
orthobiologics portfolio that is designed to facilitate
fusion. OsteoBallast, which consists of a resorbable mesh
containing 100% DBM without a carrier, simplifies graft placement
and helps prevent graft migration while maximizing DBM content.
OsteoBallast is designed to provide surgeons with a simple means
for delivering bone graft in posterior spine surgery that contours
to the local anatomy while maintaining shape and volume under
compression. The simplified technique is particularly valuable in
MIS procedures, where placing the graft accurately through tubes
and small incisions can be challenging.
“This product demonstrates SeaSpine’s continued commitment to
innovation and our focus on delivering improved procedural spine
solutions and clinical value through cost-effective
orthobiologics,” commented Tyler Lipschultz, SeaSpine’s Vice
President of Orthobiologics and Business Development. “Coupled with
the recent launch of our OsteoStrand™ Demineralized Bone Fibers
product and our established Accell Bone Matrix (ABM) technology,
SeaSpine now can offer surgeons additional options to address the
varied needs of their patients.”
SeaSpine plans to launch the OsteoBallast product with a limited
release by year-end and full commercial launch by mid-2018.
About SeaSpineSeaSpine (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 implants 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 implant 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
fusion hardware product development helps SeaSpine to
offer its surgeon customers 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 features and potential benefits of
OsteoBallast DBM in Resorbable Mesh, including its ability to
provide surgeons a simple means for delivering bone graft in
posterior spine surgeries and help prevent graft migration during
posterolateral fusion, as well as contour to local anatomy and
maintain shape and volume under compression; and the timing of
limited and full commercial launches of OsteoBallast DBM in
Resorbable Mesh. 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 OsteoBallast DBM in Resorbable Mesh 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
OsteoBallast DBM in Resorbable Mesh; the risk that OsteoBallast DBM
in Resorbable Mesh may not demonstrate adequate safety or efficacy,
including improved fusion, 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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