Pioneer(R) Surgical Technology's NuBac(R) Nucleus Replacement Device Wins FDA Approval for IDE Piv...( First Company to Reach Pivotal S...),Health

First Company to Reach Pivotal Study for Spine Nucleus Replacement

MARQUETTE, Mich., Oct. 30 /PRNewswire/ -- Pioneer Surgical Technology, Inc. announced today, the U.S. Food and Drug Administration (FDA) granted approval to proceed to IDE Pivotal Study of the NuBac(R) Nucleus Replacement Device for the spine.

Pioneer's CEO and Chairman of the Board, Matthew N. Songer, MD, MBA says, "This is a huge milestone and accomplishment for Pioneer to be the first to receive FDA approval to start the IDE pivotal study for nucleus replacement. Many other companies, pursuing nucleus replacement technology, have spent more time and money than Pioneer and have not achieved this significant goal." Songer added, "This record speed to obtain FDA approval to proceed demonstrates our dedication to focused innovation and ability to bring new products to market faster than many of our competitors."

The NuBac implant system is the only Nucleus Replacement device that utilizes an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions while minimizing extrusion risk. The NuBac implant is made of PEEK-OPTIMA(R) material which offers well established biocompatibility, biodurability, excellent wear resistance, and radiolucency.

Pioneer's Vice President for Advanced Spine, Chip Bao, PhD states, "There are some inherent challenges in the development of nucleus replacement devices. Pioneer's unique design features of the NuBac implant have led to a series of successful pre-clinical studies and encouraging results from both the initial U.S. IDE feasibility study and post-market surveillance outside the U.S. under the CE mark."

Spinal Disc Arthroplasty surgery includes Total Disc Replacement (TDR) and Nucleus Replacement procedures. Both techniques seek to relieve discogenic back pain caused by degenerative disc disease, restore stability and flexibility to
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