вторник, 26 апреля 2011 г.

Osteotech Receives FDA Clearance For First Product Under Its Plexus Technology Platform

Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration
("FDA") has cleared its 510(k) submission for an osteoconductive,
bone/polymer biocomposite, which will be the first commercial product
manufactured under Osteotech's proprietary Plexus Technology Platform. This
new product, which will be marketed under the trade name Plexur(TM) P, is a
porous, resorbable scaffold that can be used to fill bony voids of the
pelvis and extremities.



Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer,
stated, "We are very pleased to be able to introduce the Plexur(TM) P. Our
internal team has done an excellent job developing this product and with
this approval we expect to introduce additional products utilizing the
Plexus Technology in the future."



Plexur(TM) P is an osteoconductive biocomposite of cortical mineralized
bone fibers suspended in a resorbable porous polymer scaffold that has
demonstrated controlled remodeling and resorption characteristics.
Plexur(TM) P incorporates overlapping bone fibers with interconnected
pores, which simulate bone structure, facilitate absorption of blood and
allowing multiple pathways for bone forming cells to begin the remodeling
process. Plexur(TM) P will initially be available as granules and
cylindrical plugs, but ultimately, will be available in multiple forms
including blocks, wedges and sheets. Plexur(TM) P uses proprietary
processing steps that have been shown to inactivate viruses. Plexur(TM) P
is also terminally sterilized.



Mr. Owusu-Akyaw concluded, "Plexur(TM) P will be officially introduced
at the American Academy of Orthopedic Surgeons 2007 Annual Meeting,
February 14 through 16, 2007, in San Diego, California. Plexur(TM) P will
be positioned to compete against osteoconductive synthetic bone void
fillers. We expect to begin distributing Plexur(TM) P in March 2007 at key
centers of excellence to allow for the gathering of human clinical
information before a worldwide launch of the product in the third quarter
of 2007. This is in line with our strategy to use science to market
osteo-biologic products."



The Plexus 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 controls over 17 patents and over
68 pending patent applications covering the Plexus Technology for human and
xenograft bone tissue.



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 inability to obtain
required regulatory approvals for products on a timely basis or at all,
differences in anticipated and actual product and service introduction
dates, the ultimate success of those products in the market place, 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
February 8, 2007 and the Company undertakes no duty to update this
information.



Osteotech, Inc., headquartered in Eatontown, New Jersey, is a leading
provider of human bone and bone connective tissue for transplantation and
an innovator in the development and marketing of biomaterial and implant
products for musculoskeletal surgery. For further information regarding
Osteotech or this press release, please go to Osteotech's website at
osteotech.


Osteotech, Inc.

osteotech

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