EATONTOWN, N.J., Jan. 9 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration ("FDA")
has cleared Osteotech's fifth 510(k) submission for its family of DBM
products. This 510(k) submission, which covers Osteotech's Grafton(R) DBM
Gel, Putty, Flex, Matrix and Crunch, cleared these tissue forms for use in
dental, oral and cranio/maxillofacial procedures. In these procedures,
Grafton(R) DBM is intended to be used to fill and/or augment bone defects that
may be surgically created or created by traumatic injury to the bone.
Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer,
stated, "Beginning in late 2004, we began the process to obtain FDA clearance
for our DBM product line by filing five separate 510(k) applications between
late 2004 and mid 2005. We have now been successful in obtaining clearance
for all five of these 510(k) submissions. We are particularly pleased that we
have been successful in obtaining clearance for all of the indications for
which we have applied, and we believe our Grafton(R) DBM product line has
received FDA clearance for the broadest product indications of any DBM product
on the market, including Grafton(R) DBM as a bone graft substitute in
orthopedic indications."
Grafton(R) DBM is an osteoinductive and osteoconductive, demineralized
bone product that is utilized for bony voids or gaps of the skeletal system
not intrinsic to the stability of the bony structure and is remodeled and
replaced by host bone during the healing process. Grafton(R) DBM may be
processed utilizing our aseptic process or with our new validated, proprietary
terminal sterilization process. Grafton(R) DBM is prepared utilizing a
proprietary processing method that has been validated to consistently produce
a DBM that is osteoinductive in an athymic rat model. Our proprietary process
is also 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 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
January 9, 2006 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.
SOURCE Osteotech, Inc.
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Related links:
http://www.osteotech.com
Company News On-Call:
http://www.prnewswire.com/comp/668050.html
CONTACT:
Mark Burroughs, Osteotech, Inc.,
+1-732-542-2800
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