Spine Wave, Inc. Receives FDA Clearance for CapSure(TM) PS Pedicle Screw System
Published: Apr 17, 2007
SHELTON, CT -- (MARKET WIRE) -- 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.
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"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, Inc.
Spine Wave, headquartered in Shelton, Connecticut, 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 NuCore™ 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.
Contact: Carmen L. Diersen Chief Financial Officer (203) 944-9494, extension 111 CDiersen@SpineWave.com
SOURCE: Spine Wave