Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix Clinical Trial

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Wed Jun 10, 2009 6:30am EDT

Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix
Clinical Trial

First-In-Class Human Collagen Technology Used in Cranial Surgical Procedures

EATONTOWN, N.J., June 10 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq:
OSTE), a leader in the emerging field of biologic products for regenerative
healing, announced today that it has completed enrollment for the clinical
trial of its DuraTech(TM) BioRegeneration Matrix.  Based upon Osteotech's
proprietary HCT(TM) (human collagen technology) platform, DuraTech is used to
repair dura mater (the tough, outermost membrane surrounding the brain and
spinal cord) during cranial surgical procedures.  

DuraTech is the first of several products that Osteotech is developing based
upon its first-in-class HCT platform. A total of 60 patients were enrolled in
the clinical study and the trial will evaluate the patients at 30 and 90 days
post-operatively to assess the safety of DuraTech compared to historical
surgical procedure outcomes. Osteotech plans to utilize the results stemming
from this trial to support its 510(k) filing for marketing clearance with the
United States Food and Drug Administration later this year.

"The new dural substitute, DuraTech, provides a unique solution for surgeons,"
said Dr. Carl Bruce, Consultant Neurosurgeon at the University of the West
Indies, who was one of the investigating surgeons participating in the
clinical trial. Dr. Bruce continued, "DuraTech is strong enough to hold
sutures, but at the same time handles easily and conforms to convexity, making
it ideal for onlay grafts. This important combination is not present in many
other products currently on the market." Dr. Oscar Aponte, Neurosurgeon,
Professor of Rosario University and Dr. Mauricio Riveros Castillo, Chief of
Neurosurgery, Samaritana University Hospital and Hospital Mayor, the two
remaining surgeons participating in the clinical trial added, "DuraTech was
easy to use, handled well and provided the flexibility needed for different
surgical procedures quickly taking the shape of the underlying tissue."

DuraTech is the leading product in Osteotech's HCT platform, which is based on
Osteotech's breakthrough and proprietary first-in-class biomaterial. DuraTech
will provide surgeons with greater flexibility to cut, shape and suture the
material to fit each patient's needs. Based on available data, Osteotech
estimates that the annual market for dural repair substitutes is approximately
$100 million.  
 
In addition to DuraTech, which is expected to launch late this year, Osteotech
plans to introduce additional tissue products based upon its HCT platform over
the next several years that address patient needs and expand the addressable
market for this innovative technology. These products include: rotator cuff
repair, wound care applications and abdominal wall reconstruction; Osteotech
estimates that this expanded addressable market opportunity will eventually be
in excess of $1 billion yearly.

"We remain on track to file our 510(k) for DuraTech during the third quarter
of 2009 and anticipate clearance of the product before the end of the year,"
said Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "We
look forward to evaluating the results of the clinical trial and believe that
the data will show that our first-in-class biomaterial stimulates the body's
natural healing processes and helps reduce the potential for immune reactions.
Our HCT platform will support a variety of new products currently in
development and we are excited about its future. We believe the technology
platform will yield safe and clinically effective regenerative healing
products that can satisfy the emerging needs of surgeons and the patient
communities they serve."

About DuraTech(TM) BioRegeneration Matrix 
Utilizing Osteotech's HCT platform, DuraTech is an engineered nano-structure
human collagen material that provides a porous scaffold to facilitate cellular
in-growth and healing. The DuraTech BioRegeneration Matrix is the lead product
in Osteotech's collagen platform and is designed to be utilized to repair the
dura mater, a fibrous membrane that protects the brain and the spinal cord,
when the dura mater has been compromised due to injury or surgery. Osteotech's
proprietary collagen technology platform is supported by three pending patent
applications.

About Osteotech
Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global leader in
providing biologic 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, please go to Osteotech's website at 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 June 10, 2009 and the Company does not intend to
update this information.


SOURCE  Osteotech, Inc.

Mark H. Burroughs, +1-732-542-2800; Investors: Jennifer Beugelmans,
+1-646-596-7473; or Media: Keri Mattox, +1-215-791-0105
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