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.

    LAUSANNE, Switzerland, IRVINE, California, December 8
/PRNewswire-FirstCall/ -- IsoTis OrthoBiologics (SWX/Euronext: ISON) (TSX:
ISO) today announced it received 510(k) clearance from the US Food and Drug
Administration (FDA) for the use of OrthoBlast II(R) in orthopedic
applications.
    IsoTis OrthoBiologics has previously obtained 510(k) clearances for
DynaGraft II(TM), Accell Connexus (TM), OsSatura(TM), and its bone marrow
aspiration kit Aspirex. Accell(R) DBM100 and Accell TBM(TM), having no
excipient carriers, are regulated by the FDA as human tissue and not as
medical devices requiring premarket clearance.
    Pieter Wolters, President and CEO of IsoTis said: "With the 510(k)
clearance of OrthoBlast II, all IsoTis' marketed products are in compliance
with FDA regulations, and we can continue to focus on servicing the
orthopedic profession with products that are first in class in the bone
grafting market. The increased uptake of our innovative Accell product line
as a result of the high levels of BMPs it contains, and the solid market
position of first generation products like OrthoBlast II, provide us with a
healthy basis for growth in the years to come."
    OrthoBlast II is a combination of demineralized bone matrix (DBM) with
cancellous bone chips delivered in a reverse phase medium. The reverse phase
medium becomes more viscous at body temperature, but less viscous at cooler
temperatures. Therefore, it is malleable at operating room temperatures, but
thickens when placed in the operative site. This allows the DBM to be
contained at the graft site with minimal loss through irrigation and suction.
    IsoTis OrthoBiologics has a product portfolio with several innovative and
proprietary natural and synthetic bone graft substitutes on the market and
others in development, an established North American independent distribution
network, and an expanding international presence. The company's main
commercial operations are based out of Irvine, CA; its international sales
headquarters is based in Lausanne, Switzerland.
    Certain statements in this Press Release are "forward-looking statements"
within the meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, including those that refer to management's plans and expectations
for future operations, prospects and financial condition. Words such as
'strategy,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'will,'
'continues,' 'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and other
words of similar meaning are intended to identify such forward-looking
statements. One can also identify them by the fact that they do not relate
strictly to historical or current facts. Such statements are based on the
current expectations of the management of IsoTis S.A. only. Undue reliance
should not be placed on these statements because, by their nature, they are
subject to known and unknown risks and can be affected by factors that are
beyond the control of IsoTis. Actual results could differ materially from
current expectations due to a number of factors and uncertainties affecting
IsoTis' business, including but not limited to the timely commencement and
success of IsoTis' clinical trials and research endeavors, delays in
receiving U.S. FDA or other regulatory approvals (a.o. EMEA, CE), market
acceptance of the Company's products, development of competing therapies
and/or technologies, the terms of any future strategic alliances, the need
for additional capital, the inability to obtain, or meet conditions imposed
for the required governmental and regulatory approvals and consents. IsoTis
expressly disclaims any intent or obligation to update these forward-looking
statements except as required by law. For a more detailed description of the
risk factors and uncertainties affecting IsoTis, refer to the Company's
Annual Report on Form 20-F for the fiscal year ended December 31, 2004, filed
with the SEC and to IsoTis' reports filed from time to time with the Swiss
Stock Exchange (SWX), Euronext Amsterdam N.V., and SEDAR at http://www.sedar.com, as
well as the Toronto Stock Exchange (TSX).



SOURCE IsoTis OrthoBiologics