EATONTOWN, N.J., Dec. 22 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration ("FDA")
has cleared its 510(k) submission for the majority of its family of Grafton(R)
DBM products for use as a bone graft extender, bone graft substitute and bone
void filler in orthopedic indications. Covered in this application are
Osteotech's Grafton(R) DBM Gel, Putty, Flex, Matrix, Crunch and Orthoblend.
The FDA previously cleared Osteotech's 510(k) submissions for Grafton Plus(R)
DBM Paste for use in dental and orthopedic procedures and Osteotech's private
label Viagraf(TM) DBM Paste for orthopedic procedures.
Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer,
stated, "We are very pleased that in this most recent clearance, approval was
received for Osteotech to process Grafton(R) DBM products utilizing our
current aseptic process or with our new validated, proprietary terminal
sterilization process. Our goal of receiving FDA clearance for our Grafton(R)
DBM product line as a bone graft extender, bone graft substitute and bone void
filler in orthopedic indications has been achieved. We believe Grafton(R) DBM
is the only DBM product on the market to receive clearance for all of these
indications and we believe the only DBM product to be cleared as a bone graft
substitute."
Mr. Owusu-Akyaw continued, "Our Grafton(R) DBM products are 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."
Mr. Owusu-Akyaw concluded, "We are particularly pleased that we have been
successful in obtaining clearance for all of the indications for which we have
applied related to the four 510(k) clearances received to date. In the near
future, we anticipate receiving one additional 510(k) clearance for our
Grafton(R) DBM product line for use in dental applications. We would like to
thank our surgeons, customers and other users of our Grafton(R) DBM products
for their support and patience during this approval process."
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. The voids or gaps may
be surgically created defects or defects created by traumatic injury to the
bone. Grafton(R) DBM is remodeled and replaced by host bone during the
healing process.
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, 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
December 22, 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.
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:
Michael J. Jeffries, Osteotech, Inc.,
+1-732-542-2800
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