EATONTOWN, N.J., March 4 /PRNewswire-FirstCall/ -- Osteotech, Inc. , 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 activities under our Plexur(R) Technology and expect to deliver additional innovative products in the future.”
Mr. Owusu-Akyaw concluded, “Plexur M(TM) will be positioned to compete against osteoconductive and settable synthetic bone void fillers. We expect to begin distributing Plexur M(TM) in the next three to six months to centers of key opinion leaders to allow for the gathering of human clinical information. Osteotech will host hands-on sessions to demonstrate the Plexur M(TM) on March 5 and 6, 2008 at the American Academy of Orthopedic Surgeons 2008 Annual Meeting in San Francisco, California.”
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., headquartered in Eatontown, New Jersey, is a global leader in providing OsteoBiologic solutions for regenerative medicine to support surgeons and their patients in the repair of the musculoskeletal system through the development of innovative therapy-driven products that alleviate pain, promote biologic healing and restore function. For further information regarding Osteotech or this press release, please go to Osteotech’s website at www.osteotech.com.
Certain statements made throughout this press release that are not historical facts contain forward-looking statements (as such are defined in the Private Securities Litigation Reform Act of 1995) regarding the Company’s future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company’s ability to develop and introduce new products, differences in anticipated and actual product and service introduction dates, the ultimate success of those products in the marketplace, the continued acceptance and growth of current products and services, the impact of competitive products and services, the availability of sufficient quantities of suitable donated tissue and the success of cost control and margin improvement efforts. Certain of these factors are detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission. All information in this press release is as of March 4, 2008 and the Company does not intend to update this information.
CONTACT: Mark H. Burroughs of Osteotech, Inc., +1-732-542-2800
Web site: http://www.osteotech.com/
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