Osteotech's Next Generation Grafting Material, MagniFuse(TM) Bone Graft, a Breakthrough in Bone Regeneration; MagniFuse(TM) Bone Graft seeks to redefine the standard of care in the U.S. bone graft substitute market estimated to be in excess of $1.2 billion
EATONTOWN, N.J., Nov. 7 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE), a leader in the emerging field of biologic products for
regenerative healing, announced today that its next generation grafting
material will be marketed under the brand name, MagniFuse(TM) Bone Graft.
Robert M. Wynalek, Osteotech's President - Domestic, commented, "The
MagniFuse(TM) line of next generation bone regeneration products was developed
in response to surgeon interest in a high performing, cost effective bone
graft material. We believe that the distinctive properties of MagniFuse(TM)
will redefine the bone grafting market and allow Osteotech to go head-to-head
with bone morphogenetic protein products within the marketplace. This market
is primed for a product that provides powerful bone formation and fewer
complications, all at a cost effective price. We expect MagniFuse(TM) to be
available for customers in the middle of 2009."
MagniFuse(TM) is a unique combination of allograft bone within a polymer
mesh that will provide targeted and contained delivery. The polymer mesh is
made from a biodegradable suture material and is designed for effective
cellular in-growth and complete resorption within three to six months, while
not interfering with bone regeneration. The polymer mesh provides a controlled
environment for proximate allograft interaction eliminating issues with graft
site migration or irrigation that is often seen with currently available bone
graft substitutes. As previously announced, Osteotech has received 510(k)
clearance from the United States Food and Drug Administration for
MagniFuse(TM) as a bone graft substitute, and as a bone void filler, for use
in the spine, pelvis and extremities.
The MagniFuse(TM) line of bone grafting solutions will provide a wide
range of market opportunities with tissue products specifically designed for
use in the Posterolateral Spine, Deformity and Minimally Invasive Procedures.
MagniFuse(TM) will compete in the bone graft substitute market, which is
estimated to be in excess of $1.2 billion in the United States.
"The pre-clinical animal data for MagniFuse(TM) supports its use as a
stand alone product in the Posterolateral Spine," remarked Mohammed Attawia,
MD, MS, Osteotech's Vice President of Product Development. "Further
pre-clinical work is ongoing and will be available for product launch. Our
work to date indicated that the architecture of MagniFuse(TM) delivers
performance beyond that of current bone grafting materials. We believe this
breakthrough will allow us to redefine the standard of care for bone
regeneration."
Larry Shimp, Ph.D., Osteotech's Principal Technology Officer, stated, "We
believe the enhanced properties of MagniFuse(TM) go beyond that of many other
products currently in the marketplace. We have developed a new, proprietary
process that is designed to preserve a higher concentration of naturally
occurring growth factors already present in human bone, while preserving the
natural orientation and nanofibrous structure of the bone. The process of
recovering a higher growth factor content from allograft bone is the subject
of an outstanding patent application, and the technology that preserves the
nanofibrous structure is covered by a patent and a pending patent
application."
Osteotech also has a patent pending technology that controls the
remodeling properties of the allograft bone used in MagniFuse(TM).
MagniFuse(TM) is designed to be radiopaque allowing the surgeon to identify
the bone graft in post operative x-rays, which is the subject of another one
of Osteotech's patents. Overall, the MagniFuse(TM) technology is supported by
seven total patents and patent applications.
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 November 7, 2008 and the Company does not intend
to update this information.