Spine Wave, Inc. Receives FDA Clearance for the StaXx(R) FX Structural Kyphoplasty System

2007-04-16

SHELTON, CT--(MARKET WIRE)--Apr 16, 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 StaXx® FX Structural Kyphoplasty System for the treatment of vertebral compression fractures. The StaXx® FX System features innovative PEEK wafers which are stacked in situ to simultaneously distract and support the fractured vertebral body. The minimally invasive system is designed to provide pain relief and a controlled vertical fracture reduction. Mark LoGuidice, Chairman and Chief Executive Officer of Spine Wave, commented: "The FDA's clearance of the StaXx® FX System is a key milestone for Spine Wave. This allows us to enter a large, rapidly growing market with a very promising and highly differentiated technology. As one of three major products we will bring to the U.S. market in 2007, the StaXx® FX System will play a pivotal role in helping us to attract and build a world-class direct U.S. sales organization." "I have been working closely with the Spine Wave engineers on the development of this technology for several years," stated Harvinder Sandhu, M.D., of the Hospital for Special Surgery in New York. "The system has performed well in extensive laboratory tests. In addition, the European clinical results have been very encouraging. I believe the StaXx® FX System will prove to be a tool which will allow physicians to provide immediate pain relief and meaningful sagittal correction when treating patients with vertebral compression fractures." Spine Wave will begin a controlled release of the StaXx® FX System during the second quarter of 2007. Physician training will be the focus throughout the remainder of 2007 with a market launch expected later in the year. 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(TM) PS Spine System and several additional products in development. For further information, visit the Company's website at Contact: Contact: Carmen L. Diersen Chief Financial Officer (203) 944-9494, extension 111 CDiersen@SpineWave.com Source: Spine Wave >>> Discuss This Story

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