Osteotech Receives Its First Grafton(R) DBM 510(k) FDA Clearance Bone Graft Paste

Osteotech Receives Its First Grafton(R) DBM 510(k) FDA Clearance Bone
Graft Paste

EATONTOWN, N.J., Nov. 29 /PRNewswire-FirstCall/ — Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration
(“FDA”)
has cleared its 510(k) for Grafton Plus(R) DBM Paste for use as a bone
graft
extender, bone graft substitute and bone void filler in orthopedic
procedures.
    Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer,
stated, “The Grafton Plus(R) DBM Paste 510(k) for orthopedic use is the
first
of five previously reported 510(k) applications that the Company has
filed
with the FDA covering its family of Grafton(R) DBM products.  We are
particularly pleased that this 510(k) application has been cleared for
all the
indications for which we applied.  To our knowledge, this is the only
DBM
product on the market to receive clearance as a bone graft extender,
bone
graft substitute and bone void filler.”
    Mr. Owusu-Akyaw concluded, “We look forward to the FDA clearing, in
the
near future, the remaining four 510(k) applications covering our
Grafton(R)
DBM family of products.  We have been working diligently with the FDA
reviewers on all of our 510(k) applications and we believe that they
will
receive clearance by the Agency.”
    Grafton Plus(R) DBM Paste is a demineralized bone product that has
been
proven to be osteoinductive in an athymic rat in vivo model as well as
being
osteoconductive.  Further, results of bone formation studies in animals
showed
that Grafton Plus(R) DBM Paste performed comparably to autograft. 
Grafton
Plus(R) DBM is prepared utilizing a proprietary processing method that
has
been validated to consistently produce DBM that is osteoinductive in an
athymic rat model and has been validated to inactivate a panel of
viruses,
including: HIV-1, hepatitis B (using a duck hepatitis virus as a model),
hepatitis C (using a bovine diarrhea virus as a model), CMV and polio. 
This
validated process is used to further reduce the risk of disease
transmission
beyond the protection provided by donor testing and screening
procedures.

    Certain statements made in 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 the 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 failure of the FDA to clear the Company's additional
510(k)
submissions for its Grafton(R) DBM and private label product lines, the
continued acceptance and growth of current products and services,
differences
in anticipated and actual product and service introduction dates, the
ultimate
success of those products in their marketplace, 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 (including the Annual report on Form 10-K for the year
ended
December 31, 2004 and the Form 10-Q for each of the first three
quarters of
2005) filed with the Securities and Exchange Commission.  All
information in
this press release is as of November 28, 2005 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 homepage at
http://www.osteotech.com
and to Osteotech's Financial Information Request Form
website page at http://www.osteotech.com/finrequest.htm.

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