EATONTOWN, N.J., Dec. 8 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration ("FDA")
has cleared its 510(k) application for Viagraf(TM) DBM Paste, one of
Osteotech's private label tissue forms, for use as a bone void filler in
orthopedic procedures. In these procedures, Viagraf(TM) DBM Paste is intended
to be used to fill bone defects in the extremities that may be created
surgically or by traumatic injury to the bone.
Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer,
stated, "We are very pleased that three of the five 510(k) applications filed
with the FDA by the Company for its family of DBM products have been cleared
so far, with all the claims that we had requested. We continue to work
diligently with the FDA on the remaining two 510(k) applications covering the
remainder of our DBM family of products and look forward to receiving FDA
clearance in the near future."
The Company previously announced on November 29, 2005 that it had received
510(k) clearance for Grafton Plus(R) DBM Paste for use in orthopedic
procedures and announced on December 5, 2005 that it had received 510(k)
clearance for Grafton Plus(R) DBM Paste for use in dental, oral and
cranio/maxillofacial 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 December 8, 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 of Osteotech,
+1-732-542-2800
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