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Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the United States
Date:4/22/2010

facets, and is designed to achieve segmental reconstruction from a single posterior approach," declared Erik Wagner, Chief Technical Officer.

"We are extremely proud of reaching this milestone after completing the tremendous amount of work that went into the development of the FSU device.  We are moving into this next phase of our business to verify and validate the science and technology behind the product," stated Vincent Jannetty, President and CEO of Flexuspine.

"We also just recently received multiple 'notices of allowance of claims' from the U.S. Patent and Trademark Office.  We are very pleased that these claims cover both the system and key features of the product.  This recognition by the patent office of the novelty of the system along with the launch of the clinical study, create the solid business foundation we have been working towards," continued Jannetty.  

Flexuspine plans to begin patient enrollment in the U.S. feasibility study soon while continuing to establish similar clinical study sites in several countries outside the U.S.  The goal of these international studies was, and still is, to collect additional data that may be used in support of a U.S. Pivotal Clinical Trial.  

About Flexuspine

Flexuspine is a privately held spine company based in Pittsburgh, PA.  Flexuspine is dedicated to the sole focus of pioneering the field of total spine arthroplasty by developing the FSU device as an alternative to lumbar fusion. For more information on Flexuspine please visit

SOURCE Flexuspine, Inc.
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