EATONTOWN, N.J., Dec. 20 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration ("FDA")
has cleared its 510(k) application for the GraftCage(TM) TLX System, the
second approval for Osteotech's GraftCage(TM) Product Line in the last two
weeks. The GraftCage(TM) TLX, along with the GraftCage(TM) ACX, is
manufactured from Invibio's PEEK-OPTIMA(R) polymer.
Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer,
stated, "We now have FDA clearance to distribute two different products in our
GraftCage(TM) Product Line, the GraftCage(TM) ACX and GraftCage(TM) TLX, both
of which we anticipate distributing in the first quarter of 2006. These two
new products, along with additional GraftCage(TM) Product Line extensions we
expect to introduce in 2006, will allow Osteotech to compete in that portion
of the spinal interbody market dominated by PEEK products, which in 2005
approximates $221 million."
Mr. Owusu-Akyaw continued, "We have coordinated the design of our
GraftCage(TM) Product Line with the design of our Xpanse(TM) Bone Inserts to
allow us to have an Xpanse(TM) Bone Insert which can be utilized with each
GraftCage(TM) Product configuration. When used together, the GraftCage(TM)
Products and the Xpanse(TM) Bone Inserts create a unique vertebral body spacer
allowing for maximum endplate contact, structural support, osteoinductivity
and osteoconductivity. We believe the use of our Xpanse(TM) Bone Inserts with
our GraftCage(TM) PEEK based products gives us a competitive advantage over
other spinal implants manufactured from PEEK."
The GraftCage(TM) TLX, like the GraftCage(TM) ACX, is designed for
strength and ease of insertion by surgeons, can be implanted utilizing
existing Osteotech instrumentation and features titanium markers to facilitate
intra-operative and post-operative radiographic assessments. The
GraftCage(TM) TLX is intended to replace a collapsed, damaged, or unstable
vertebral body in the thoracic or lumbar spine. It is indicated for a partial
or total vertebrectomy in cases of tumor or trauma related damage to the
vertebral body. The GraftCage(TM) TLX is intended to achieve anterior
decompression of the spinal cord and neural tissues and to restore the height
of a collapsed vertebral body.
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
20, 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, Inc.,
+1-732-542-2800
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