SeaSpine Announces Launch of Regatta™ Lateral System
September 26 2018 - 8:15AM
SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical
technology company focused on surgical solutions for the treatment
of spinal disorders, today announced the launch of the
Regatta™ Lateral System, featuring
NanoMetalene® technology.
Regatta is a comprehensive, minimally invasive
lateral interbody fusion system designed to efficiently and
reproducibly treat the spine through indirect decompression and the
restoration of sagittal alignment. Regatta offers a wide variety of
implants to accommodate the patient’s anatomy, including 10 and 15
degree lordotic options for sagittal alignment and 18 and 23mm wide
implants for complete endplate coverage. The Regatta lateral
retractor and the EMG nerve detection dilators allow for
customizable access with minimal tissue disruption through the
psoas, while also providing the visualization necessary to
effectively perform the procedure. The addition of new streamlined
disc preparation and angled instruments to access challenging disc
spaces combine to deliver the complete procedural solution.
“We are excited to provide this comprehensive
lateral system to surgeons who perform less-invasive interbody
fusion procedures that minimize the tissue disruption that
typically accompanies traditional spinal fusion surgery. By
optimizing each procedural element, from access to fusion, the
surgeon can efficiently and effectively treat each patient’s unique
spinal condition,” said Keith Valentine, President and Chief
Executive Officer.
The Regatta interbody devices feature proprietary
NanoMetalene surface technology. NanoMetalene is a sub-micron layer
of commercially pure titanium molecularly bonded to a PEEK implant
using a high-energy, low-temperature process referred to as atomic
fusion deposition. It is designed to provide implants a
bone-friendly titanium surface on endplates and throughout graft
apertures, while retaining the benefits associated with traditional
PEEK implants, such as biocompatibility, a modulus of elasticity
similar to bone, and excellent radiographic visibility for
post-operative imaging.
“The Regatta system offers a variety of sizes and
angles of interbody implants to address the majority of patient
anatomy requirements and my surgical correction goals.
Additionally, the implant’s novel NanoMetalene titanium surface
technology may allow for more rapid and reliable fusion healing,
and allows me to consider a wider variety of graft materials,
potentially reducing the cost of care,” stated Dr. James Bruffey,
Orthopedic Spine Surgeon, Scripps Health - San Diego, CA.
SeaSpine will be conducting initial cases through a
limited launch over the coming months and expects a full commercial
launch of the Regatta Lateral System in the first half of
2019.
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 implants 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
implants product development allows SeaSpine to offer its surgeon
customers a differentiated portfolio and a complete procedural
solution to meet their fusion requirements. SeaSpine currently
markets its products in the United States and in over 30 countries
worldwide.
Forward-Looking StatementsSeaSpine
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 of the Regatta
Lateral System to efficiently and reproducibly treat the spine, to
provide customizable access with minimal tissue disruption while
providing necessary visualization, and to access challenging disc
spaces; the ability of the Regatta Lateral System to deliver a
complete procedural solution and efficiently and effectively treat
each patient’s unique spinal condition; and the timing of initial
cases and full commercial launch of the Regatta Lateral System.
Among the factors that could cause or contribute to material
differences between the Company’s actual results and the
expectations indicated by the forward-looking statements are risks
and uncertainties that include, but are not limited to: the ability
of newly launched products to perform as designed and intended and
to meet the needs of surgeons and patients, including as a result
of the lack of clinical validation of products in limited
commercial (or “alpha”) launch; unexpected delay, including as a
result of developing and supporting the launch of new products,
including the fact that newly launched products may require
substantial additional development activities, which could
introduce further delay, or as a result of obtaining regulatory
clearances; and other risks and uncertainties more fully described
in the Company’s 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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