IsoTis Receives FDA Clearance for Accell Family of Products

    IRVINE, CA, Aug. 20 /CNW/ - 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 forward."

    About IsoTis

    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 in

    Forward-Looking Statements

    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 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 Documents
filed with the SEC by IsoTis will be available free of charge on the investor
relations portion of the IsoTis website at

    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.

For further information:

For further information: Rob Morocco, CFO, (949) 855-7155,; Hans Herklots, Director IR, (949) 855-7195 or

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890