EATONTOWN, N.J., July 29 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative healing, announced today that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for Plexur M(TM) Biocomposite for use in spinal applications. In spinal applications, Plexur M(TM) may be used in conjunction with autograft as a bone void filler. In March 2008, Osteotech received FDA clearance for Plexur M(TM) to be used in filling bony voids or gaps in the pelvis and extremities.
Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer, stated, "We are very pleased to receive FDA clearance for use of Plexur M(TM) in the spine. Plexur M(TM) is the second, of what we hope to be many more, bone-polymer biocomposites developed under our proprietary Plexur(R) Technology."
Mr. Owusu-Akyaw continued, "We are in the process of completing all of our internal activities for a limited launch of Plexur M(TM). By the end of the third quarter, we plan to introduce Plexur M(TM) to a small, select group of key surgeons who will utilize the product in a wide variety of orthopedic procedures, including spine, trauma and joints. We will utilize the knowledge gained from these surgeons to finalize our product uses, complete our technique guides and marketing materials and train our sales team."
The Plexur(R) Technology is designed to utilize bone tissue for procedure-specific surgical applications in combination with a wide variety of polymers. On a worldwide basis, Osteotech currently controls 33 patents and over 65 pending patent applications covering the Plexur(R) Technology for human and xenograft bone tissue.
Osteotech, Inc., hea
|SOURCE Osteotech, Inc.|
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