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Medyssey Spine Receives 510(k) Clearance for Its LP Cage(TM) Posterior Lumbar Interbody Fusion System
Date:4/13/2011

CHICAGO, April 13, 2011 /PRNewswire/ -- Medyssey Co., Ltd., the parent company of Medyssey Spine, a spinal implant manufacturer focused on commercializing products for the surgical treatment of spine disorders, today announced that the Company has received 510(k) clearance from the FDA for its LP Cage™ indicated for use in skeletally mature patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1 from a posterior approach for lumbar interbody fusion. The product is currently in limited, controlled release and is targeted for full commercial launch by Q4 2011.

According to Frost & Sullivan, more than 30 million people in the United States suffer from back pain. While physical therapy and medication provide a solution in many cases, a subset of approximately 15 percent, about 4.5 million people, still experience chronic back pain requiring the next level of treatment which is spinal surgery, involving spinal fusion, or in some cases, total disc replacement.  

Medyssey Spine's LP Cage™ device addresses the market need for advanced spinal fusion solutions with an indication comprised of two footprints with three varying degrees of lordosis and substantial graft windows for maximum endplate to endplate contact.  

"Given the challenging regulatory climate, we are extremely pleased to obtain clearance, and we are eager to introduce, market, and sell the first of many cages of what will ultimately be an extensive portfolio of interbody fusion systems," said Joseph Jin, the Company's vice president of sales for the Americas. "Medyssey's focus is to have the most complete thoracolumbar systems on the market, which is evidenced by our robust pipeline of new products currently in regulatory submission and commitment to building out our interbody and biologics platforms," Mr. Jin added.

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SOURCE Medyssey Co., Ltd.
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