EATONTOWN, N.J., Nov. 11 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that it has been informed by the Food and Drug
Administration ("FDA") that FDA is granting Osteotech an extension to clear
its previously filed Grafton(R) DBM 510(k) applications until such time as the
Agency is able to complete its work on the applications. Specifically, the
FDA said it has decided to continue its enforcement discretion for all 510(k)
applications that are under review prior to the original deadline of
November 15, 2005. FDA also advised the Company that during the period of
enforcement discretion, Osteotech may continue to distribute its Grafton(R)
DBM products, despite the absence of cleared 510(k)s. This will remain the
case while FDA concludes its review of Osteotech's 510(k)s, so long as the
Company is actively and aggressively pursuing premarket clearance with the
Agency.
Richard W. Bauer, Osteotech's Chief Executive Officer stated, "Beginning
in 2004, Osteotech filed a series of five 510(k) applications with the FDA,
including Grafton(R) DBM Orthopedic, Grafton(R) DBM Dental, Grafton Plus(R)
DBM Orthopedic, Grafton Plus(R) Dental and Viagraf(TM) Paste Orthopedic,
covering the Company's family of Grafton(R) DBM tissue forms. Osteotech has
been working diligently with the FDA reviewers to clear all of our 510(k)
applications and expects that they will receive clearance by the Agency."
Mr. Bauer continued, "Since its initial introduction in 1991, Grafton(R)
DBM has been used in more than 600,000 procedures with an outstanding record
of being both safe and effective. The clearance issue before the FDA is one
of classification and not an issue involving either the safety or efficacy of
the family of Grafton(R) DBM products. We are pleased to have the opportunity
to continue to work closely with the FDA reviewers to gain clearance of all
our 510(k) applications."
As we previously reported, in an FDA letter dated September 16, 2005 to
all manufacturers of demineralized bone matrix products, the FDA required all
manufacturers to file and have cleared 510(k) applications covering their DBM
products by November 15, 2005. The extension, which has now been issued by
the FDA supercedes the September 16, 2005 letter and the deadline imposed by
that letter.
Certain statements made throughout 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 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 510(k) submissions for its
Grafton(R) DBM and private label product lines. 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 the first three quarters of 2005) filed with the Securities
and Exchange Commission. All information in this press release is as of
November 11, 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 and
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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