LAUSANNE, Switzerland, IRVINE, California, December 8
/PRNewswire-FirstCall/ — IsoTis OrthoBiologics (SWX/Euronext:
ISON) (TSX:
ISO) today announced it received 510(k) clearance from the US Food and
Drug
Administration (FDA) for the use of OrthoBlast II(R) in orthopedic
applications.
IsoTis OrthoBiologics has previously obtained 510(k) clearances for
DynaGraft II(TM), Accell Connexus (TM), OsSatura(TM), and its bone
marrow
aspiration kit Aspirex. Accell(R) DBM100 and Accell TBM(TM), having no
excipient carriers, are regulated by the FDA as human tissue and not as
medical devices requiring premarket clearance.
Pieter Wolters, President and CEO of IsoTis said: “With the 510(k)
clearance of OrthoBlast II, all IsoTis' marketed products are in
compliance
with FDA regulations, and we can continue to focus on servicing the
orthopedic profession with products that are first in class in the bone
grafting market. The increased uptake of our innovative Accell product
line
as a result of the high levels of BMPs it contains, and the solid market
position of first generation products like OrthoBlast II, provide us
with a
healthy basis for growth in the years to come.”
OrthoBlast II is a combination of demineralized bone matrix (DBM)
with
cancellous bone chips delivered in a reverse phase medium. The reverse
phase
medium becomes more viscous at body temperature, but less viscous at
cooler
temperatures. Therefore, it is malleable at operating room
temperatures, but
thickens when placed in the operative site. This allows the DBM to be
contained at the graft site with minimal loss through irrigation and
suction.
IsoTis OrthoBiologics has a product portfolio with several
innovative and
proprietary natural and synthetic bone graft substitutes on the market
and
others in development, an established North American independent
distribution
network, and an expanding international presence. The company's main
commercial operations are based out of Irvine, CA; its international
sales
headquarters is based in Lausanne, Switzerland.
Certain statements in this Press Release are “forward-looking
statements”
within the meaning of Section 21E of the Securities Exchange Act of
1934, as
amended, including those that refer to management's plans and
expectations
for future operations, prospects and financial condition. Words such as
'strategy,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'will,'
'continues,' 'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and
other
words of similar meaning are intended to identify such forward-looking
statements. One can also identify them by the fact that they do not
relate
strictly to historical or current facts. Such statements are based on
the
current expectations of the management of IsoTis S.A. only. Undue
reliance
should not be placed on these statements because, by their nature, they
are
subject to known and unknown risks and can be affected by factors that
are
beyond the control of IsoTis. Actual results could differ materially
from
current expectations due to a number of factors and uncertainties
affecting
IsoTis' business, including but not limited to the timely commencement
and
success of IsoTis' clinical trials and research endeavors, delays in
receiving U.S. FDA or other regulatory approvals (a.o. EMEA, CE), market
acceptance of the Company's products, development of competing therapies
and/or technologies, the terms of any future strategic alliances, the
need
for additional capital, the inability to obtain, or meet conditions
imposed
for the required governmental and regulatory approvals and consents.
IsoTis
expressly disclaims any intent or obligation to update these
forward-looking
statements except as required by law. For a more detailed description
of the
risk factors and uncertainties affecting IsoTis, refer to the Company's
Annual Report on Form 20-F for the fiscal year ended December 31, 2004,
filed
with the SEC and to IsoTis' reports filed from time to time with the
Swiss
Stock Exchange (SWX), Euronext Amsterdam N.V., and SEDAR at http://www.sedar.com,
as
well as the Toronto Stock Exchange (TSX).
SOURCE IsoTis OrthoBiologics