EATONTOWN, N.J., Dec. 5 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration ("FDA")
has cleared an additional 510(k) for Grafton Plus(R) DBM Paste for use in
dental, oral and cranio/maxillofacial procedures. In these procedures,
Grafton Plus(R) DBM Paste 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. On November 29, 2005, the Company announced that it had received 510(k)
clearance 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 dental, oral and
cranio/maxillofacial procedures is the second 510(k) clearance received by the
Company from a series of five previously reported 510(k) applications that the
Company has filed with the FDA covering its family of DBM products. We look
forward to the FDA clearing, in the near future, the remaining three 510(k)
applications covering our DBM family of products."
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 5, 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
http://www.osteotech.com/finrequest.htm
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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