четверг, 14 апреля 2011 г.

Osteotech Receives FDA Clearance For Plexur M(TM) Biocomposite

Osteotech, Inc.
(Nasdaq: OSTE), a leader in the emerging field of biologic solutions for
regenerative medicine, announced 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 osteotech.



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.


Osteotech, Inc.

osteotech

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