Osteotech Receives FDA Clearance for Plexur M(TM) Bi...( EATONTOWN N.J. March 4 /- Osteote...)

EATONTOWN, N.J., March 4 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative medicine, announced today that the Food and Drug Administration ("FDA") has cleared its 510(k) submission for its Plexur M(TM) Biocomposite. Adapting the Company's proprietary Plexur(R) Technology, Plexur M(TM) is intended for use in filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. During the healing process, Plexur M(TM) is remodeled and replaced by host bone.

Plexur M(TM) is a uniquely flexible biomaterial composed of mineralized cortical fibers bound in a resorbable polymer. When heated, this biocomposite becomes moldable and pliable allowing a surgeon numerous options for use during surgery. During the cooling process, Plexur M(TM) hardens providing a versatile porous scaffold to assist in regeneration of damaged and diseased bones. It is an ideal medium for placing screws with no cracking or resultant particulate shedding and can be reamed and reverse-reamed without dislodging the graft or damaging the surrounding bone. Plexur M(TM) uses proprietary processing steps that have been shown to inactivate viruses and is terminally sterilized.

Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer, stated, "We are very pleased to be able to introduce the Plexur M(TM) Biocomposite. Our internal team has done an excellent job to develop this product and receive FDA clearance for orthopedic applications. We anticipate filing an additional 510(k) submission for the use of Plexur M(TM) in spinal applications in the first part of the second quarter. We plan to continue our research and development activitie
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