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Osteotech's Plexur P(TM) Receives FDA Clearance As Bone Void Filler And Bone Graft Extender In Spine
Osteotech, Inc.
(Nasdaq: OSTE), a leader in the emerging field of biologic solutions for
regenerative medicine, announced that the United States Food and Drug
Administration ("FDA") has cleared its 510(k) submission for the Plexur
P(TM) Biocomposite for use in spinal applications as a bone void filler and
as a bone graft extender. Previously, Osteotech received FDA clearance for
Plexur P(TM) for use in filling bony voids of the pelvis and extremities.
Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer,
stated, "We are very pleased to receive FDA clearance for the use of our
Plexur P(TM) product in the spine. We continue to receive many favorable
comments from orthopedic surgeons about the efficacy of Plexur P(TM) and we
will immediately offer our Plexur P(TM) product to spine surgeons supported
by the clinical information and experience we have gained over the last
year. Our proprietary Plexur(R) Technology continues to be one of the keys
to our product pipeline and future growth initiatives."
To date, the Plexur P(TM) Biocomposite has been used by a variety of
surgeons in tibial plateau fractures, tibial osteotomies and a variety of
foot and ankle procedures, and can now be used in the spine. Our Plexur
P(TM) product can be combined with our proprietary Grafton(R) DBM, local
bone or our new Kinesis(TM) BMAC(TM) cellular system. Plexur P(TM) is
available as granules, cylinders, blocks, wedges and sheets. For more
information about the Plexur P(TM) Biocomposite, please go to our websites
at http://www.plexur.com or http://www.osteotech.com.
The Plexur(R) Technology uses bone tissue for procedure specific
surgical applications in combination with a wide variety of polymers. On a
world-wide basis, Osteotech controls over 33 patents and over 65 pending
patent applications covering this 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 or this press release, 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 April 25, 2008 and the Company does not intend to
update this information.
Osteotech, Inc.
http://www.osteotech.com
Osteotech lui Plexur P (TM) Primeºte FDA Clearance Ca Bone Void de umplere ºi oase Graft extenderul În Spine - Osteotech's Plexur P(TM) Receives FDA Clearance As Bone Void Filler And Bone Graft Extender In Spine - articole medicale engleza - startsanatate