EATONTOWN, N.J., July 29 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE), a leader in the emerging field of biologic solutions for
regenerative healing, announced today that the United States Food and Drug
Administration ("FDA") has cleared its 510(k) submission for Plexur M(TM)
Biocomposite for use in spinal applications. In spinal applications, Plexur
M(TM) may be used in conjunction with autograft as a bone void filler. In
March 2008, Osteotech received FDA clearance for Plexur M(TM) to be used in
filling bony voids or gaps in the pelvis and extremities.
Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer,
stated, "We are very pleased to receive FDA clearance for use of Plexur
M(TM) in the spine. Plexur M(TM) is the second, of what we hope to be many
more, bone-polymer biocomposites developed under our proprietary Plexur(R)
Technology."
Mr. Owusu-Akyaw continued, "We are in the process of completing all of
our internal activities for a limited launch of Plexur M(TM). By the end of
the third quarter, we plan to introduce Plexur M(TM) to a small, select
group of key surgeons who will utilize the product in a wide variety of
orthopedic procedures, including spine, trauma and joints. We will utilize
the knowledge gained from these surgeons to finalize our product uses,
complete our technique guides and marketing materials and train our sales
team."
The Plexur(R) Technology is designed to utilize bone tissue for
procedure-specific surgical applications in combination with a wide variety
of polymers. On a worldwide basis, Osteotech currently controls 33 patents
and over 65 pending patent applications covering the Plexur(R) Technology
for human and xenograft bone tissue.
Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global
leader in providing OsteoBiologic solutions for regenerative medicine to
support surgeons and their patients in the repair of the musculoskeletal
system through the development of innovative therapy-driven products that
alleviate pain, promote biologic healing and restore function. For further
information regarding Osteotech, this press release or the conference call,
please go to Osteotech's website at http://www.osteotech.com.
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 Company's ability to
develop and introduce new products, differences in anticipated and actual
product and service introduction dates, 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
filed with the Securities and Exchange Commission. All information in this
press release is as of July 29, 2008 and the Company does not intend to
update this information.
SOURCE Osteotech, Inc.
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Related links:
http://www.osteotech.com
http://www.prnewswire.com/comp/668050.html /
CONTACT:
Mark H. Burroughs of Osteotech, Inc.,
+1-732-542-2800
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