EATONTOWN, N.J., Sept. 12 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that it will introduce two new products at the
20th Annual Meeting of The North American Spine Society (NASS) to be held at
the Pennsylvania Convention Center in Philadelphia, Pennsylvania; the
Xpanse(TM) Bone Insert and the GraftCage(TM) TLX vertebral body replacement
device. The GraftCage(TM) TLX is pending 510(k) clearance from the U.S. Food
and Drug Administration. Attendees will be able to view both products at the
Osteotech booth (Booth No. 915) during the NASS meeting from Wednesday,
September 28, 2005 through Friday, September 30, 2005.
The Xpanse(TM) Bone Insert incorporates Osteotech's proprietary
demineralized bone fiber technology and demineralized cancellous chips to
provide a tissue graft that is osteoinductive, osteoconductive and
osteoconforming. Utilizing Osteotech's patent-pending Osteoconforming(TM)
Technology, the Xpanse(TM) Bone Insert expands up to 10 millimeters when re-
hydrated in vivo, thus providing more complete bone surface contact during a
variety of orthopaedic and reconstructive applications. The Xpanse(TM) Bone
Insert is expected to be available to surgeons beginning in October 2005.
Osteotech's GraftCage(TM) TLX, manufactured from Invibio's PEEK-OPTIMA(R)
polymer, is a vertebral body replacement device designed for strength and ease
of insertion. The GraftCage(TM) TLX can be implanted utilizing existing
Osteotech instrumentation for transverse spinal interbody procedures. The
GraftCage(TM) TLX features a large opening for the insertion of fusion
enhancing materials, including the Xpanse(TM) Bone Insert, to allow for
maximum graft exposure. It also features three titanium alloy markers to
facilitate intra-operative and post-operative radiographic assessments.
Osteotech filed for 510(k) clearance of the GraftCage(TM) TLX with the FDA in
June 2005 and anticipates receiving clearance in the fourth quarter of 2005.
Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer,
stated, "We are pleased to continue to bring new and innovative products to
the market. With the new Osteoconforming(TM) Technology, we continue to
develop and implement leading technological advancements. The Xpanse(TM) Bone
Insert and the GraftCage(TM) TLX are two products in a series of procedure-
specific products we anticipate introducing within the next year."
Mr. Owusu-Akyaw continued, "We sized the Xpanse(TM) Bone Insert to fit
within the GraftCage(TM) TLX; however, it can be utilized alone or with other
spinal implants where allograft or autograft bone would be used. Used
together, the Xpanse(TM) Bone Insert and the GraftCage(TM) TLX create a unique
vertebral body spacer allowing for maximum endplate contact, structural
support, osteoinductivity and osteoconductivity, which are the four key
components to a successful fusion."
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, differences in anticipated and actual product and service introduction
dates, the timing of approvals, if required, by governing regulatory bodies,
the ultimate success of those products in the marketplace, the continued
acceptance and growth of current products and services, 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 the each of the
first two quarters of 2005) filed with the Securities and Exchange Commission.
All information in this press release is as of September 12, 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, or Chris Allieri, The Global Consulting Group,
+1-646-284-9450
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