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Spine Wave Receives FDA Clearance for CapSure™ PS
Pedicle Screw System; U.S. Sales Force Expansion Underway to Support
Product Portfolio
Shelton, CT – April 17, 2007
Spine Wave, Inc., a company that develops and markets innovative spinal
surgical solutions, announced it has received FDA 510(k) clearance to
market its CapSure™ PS Spine System. The CapSure™ PS pedicle screw
system will complement the Company’s StaXx® XD expandable PEEK spacer,
which has also received 510(k) clearance. The Company is initiating a
limited release of the CapSure™ PS System during the second quarter of
2007 and anticipates a broader market release of both products by the
end of 2007.
Mark LoGuidice, Chairman and Chief Executive Officer, commented: “The
CapSure™ PS System has a strong intellectual property position and a
unique design which allows it to maintain maximum polyaxial angulation
even when the screw is fully seated into the pedicle. Our innovative
product portfolio, which also includes the recently cleared StaXx® FX
System - a new means for treating vertebral compression fractures - and
the NuCore™ Injectable Nucleus, has allowed us to recruit a very strong
sales management team which has already begun to build the foundation
for a world-class sales organization.” The sales management team is led
by three executives: Nick Lake, Vice President of Sales; Jim Skinner,
Vice President of Sales Development; and Ed Traurig, Vice President of
Market Development.
“With three new products and a recently announced $45 million financing,
we can aggressively pursue rapid sales team expansion,” said Nick Lake.
“Our goal is to build a strong, technically-oriented sales team that
provides first class customer service.”
About Spine Wave
Spine Wave is focused on the development of clinical solutions for three
of the largest and fastest growing spinal market segments: nuclear
replacement and augmentation, vertebral compression fracture repair and
spinal fusion. The Company’s product portfolio includes the NuCoreTM
Injectable Nucleus, the StaXx® FX Structural Kyphoplasty System, the
StaXx® XD Expandable Device, the CapSure™ PS Spine System and several
additional products in development. For further information, visit the
Company’s website at
www.spinewave.com.
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