Irvine, California (ots/PRNewswire) - IsoTis, Inc. (NASDAQ: ISOT)
("IsoTis"), an orthobiologics company, today announced that it
received a letter dated August 15, 2007 from the US Food and Drug
Administration ("FDA"), clearing the Accell Family of Products for
marketing in the US as Class II medical devices.
The Accell Family of Products includes Accell 100, Accell Connexus
and Accell Total Bone Matrix, as well as a new Accell product that is
not currently marketed. The products are indicated for use as bone
graft extenders in the spine, extremities and pelvis, or as bone void
fillers in extremities and pelvis.
Pieter Wolters, President and CEO of IsoTis said, "We are very
pleased with the final outcome of our discussions with the FDA. With
the clearance of the Accell Family of Products we can now focus on
advancing the clinical benefits of Accell for both patients and
surgeons. The expected merger with Integra LifeSciences will further
enhance our ability to successfully market these products going
IsoTis is an orthobiologics company that develops, manufactures
and markets proprietary products for the treatment of musculoskeletal
diseases and disorders. IsoTis' current orthobiologics products are
bone graft substitutes that promote the regeneration of bone and are
used to repair natural, trauma-related and surgically-created defects
common in orthopedic procedures, including spinal fusions. IsoTis'
current commercial business is highlighted by its Accell line of
products, which the company believes represents the next generation
in bone graft substitution.
On August 7, 2007 Integra LifeSciences Holdings Corporation
(NASDAQ: IART) ("Integra") and IsoTis announced that they have
reached a definitive agreement to create a global orthobiologics
leader. The combination would create a comprehensive orthobiologics
portfolio, one of the largest sales organizations focused on
orthobiologics in the US, and multiple cross-selling opportunities.
The transaction is subject to approval of IsoTis' shareholders, as
well as other closing conditions and approvals. Upon closing, IsoTis
will become a wholly-owned subsidiary of Integra. Integra will be one
of the largest companies in the world focused on advanced technology
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, among other things, future
operations, strategies, prospects, performance and financial
condition and IsoTis' proposed acquisition by Integra. Words such as
"strategy," "expects," "plans," "anticipates," "believes," "may,"
"will," "might," "could," "would," "continues," "estimates,"
"intends," "pursues," "projects," "goals," "targets" or the negative
or other variations thereof 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 and projections of the management of IsoTis 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 and
projections due to a number of factors and uncertainties affecting
IsoTis' business, including, but not limited to the following factors
as well as other factors described from time to time in IsoTis'
reports filed with the SEC: the effects of economic, credit and
capital market conditions on the economy in general and on medical
device and health care companies in particular; IsoTis' need to raise
additional capital to continue operations; a competitive sales and
marketing environment; the timely commencement and success of IsoTis'
clinical trials and research endeavors; delays in receiving U.S. Food
and Drug Administration or other regulatory approvals (i.e., EMEA,
CE), including the risk that the FDA requires IsoTis to produce
additional clinical data to support approval or clearance of its
products, and that the FDA imposes compliance measures against IsoTis
for the marketing of its Accell products, including imposing fines
and injunctions or causing IsoTis to recall its Accell products;
market acceptance of IsoTis' products; the effectiveness of IsoTis'
distribution channels; the development of competing therapies and/or
technologies; the terms of any future strategic alliances; changes in
laws (including increased tax rates), regulations or accounting
standards, third-party relations and approvals, and decisions of
courts, regulators and governmental bodies; litigation outcomes and
judicial actions; and the inability to obtain, or meet, conditions
imposed for 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 Annual Report on Form 20-F for the
fiscal year ended December 31, 2006 of IsoTis S.A. (the predecessor
to IsoTis, Inc.), and IsoTis S.A.'s other reports filed with the SEC,
IsoTis S.A.'s reports filed from time to time with the Swiss Stock
Exchange (SWX), Euronext Amsterdam N.V., SEDAR at
http://www.sedar.com and the Toronto Stock Exchange (TSX) and the
quarterly report on Form 10-Q for the quarter ended June 30, 2007
and other reports filed with the SEC from time to time by IsoTis.
Any forward-looking statements are made pursuant to the Private
Securities Litigation Reform Act of 1995 and, as such, speak only as
of the date made. IsoTis undertakes no obligation to publicly update
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Important Information for Investors and Stockholders
IsoTis will file a proxy statement and other relevant materials
with the SEC in connection with the proposed merger with Integra.
IsoTis urges IsoTis stockholders to read the proxy statement when it
becomes available and any other relevant documents filed by IsoTis
with the SEC because they will contain important information.
Investors and stockholders will be able to obtain the proxy statement
and other documents filed with the SEC free of charge at the website
maintained by the SEC at http://www.sec.gov. Documents filed with
the SEC by IsoTis will be available free of charge on the investor
relations portion of the IsoTis website at http://www.IsoTis.com.
Participants in the Solicitation
IsoTis, and its directors and executive officers may be deemed to
be participants in the solicitation of proxies from IsoTis'
stockholders in connection with the proposed merger with Integra. The
names of IsoTis' directors and executive officers and a description
of their interests in IsoTis are set forth in IsoTis S.A.'s Annual
Report on Form 20-F, which was filed with the SEC on May 11, 2007.
Investors and stockholders can obtain more detailed information
regarding the direct and indirect interests of IsoTis' directors and
executive officers in the merger by reading the definitive proxy
statement when it becomes available.
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