30.05.2007 – 15:22

IsoTis OrthoBiologics

IsoTis Regulatory Review of Accell Products Back on Track

Irvine, California (ots/PRNewswire)

- FDA Reinitiates 510(k) Review

IsoTis, Inc. (NASDAQ: ISOT), the orthobiologics company, today
announced that it recently received a positive response from the
Center for Biologics Evaluation and Research (CBER) and the Center
for Devices and Radiological Health (CDRH) of the U.S. Food and Drug
Administration (FDA), confirming that IsoTis' Accell family of
demineralized bone matrix products will be regulated under the device
provisions of the Federal Food, Drug, and Cosmetic Act.

Following receipt of the response letter, the company engaged in
discussions with the Office of Device Evaluation (ODE) of CDRH. Based
on these discussions, the company submitted a 510(k) supplement
clarifying the claims and labeling for its Accell products today. The
company also addressed ODE's additional questions regarding the
Accell process. These discussions resulted in a confirmation that the
agency will restart the review of the pending 510(k) notice for the
Accell family of products submitted in July 2006, which had been put
on hold in February 2007. While there can be no assurance that CDRH
will not request additional information after review of the
supplement, which may cause further delays, based on it's discussions
with FDA, IsoTis hopes to receive a timely 510 (k) clearance.

Pieter Wolters, President and CEO of IsoTis said, "We are very
pleased with the outcome of our discussions with the FDA. The
confirmation from the FDA that the Accell products are regulated as
devices ends a period of uncertainty about which Center within FDA
has jurisdiction. We look forward to continue to work closely with
the FDA toward obtaining a timely 510(k) clearance of our Accell
family of products."

About IsoTis, Inc.

IsoTis is a leading 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.

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 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, 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 Company is unable to obtain 510(k)
clearance for its Accell products, that the FDA requires the Company
to produce additional clinical data to support approval or clearance
of its products, that the FDA imposes compliance measures against the
Company for the marketing of its Accell products, including imposing
fines and injunctions or causing the Company to recall its Accell
products, market acceptance of IsoTis' products, effectiveness of
IsoTis' distribution channels, 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 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, 2005 of IsoTis SA, the predecessor of
the Company, filed with the SEC, to IsoTis SA's reports filed from
time to time with the Swiss Stock Exchange (SWX), Euronext Amsterdam
N.V., SEDAR at www.sedar.com and the Toronto Stock Exchange (TSX),
and to the reports filed from time to time by the Company with the
SEC.

Contact:

For information contact: Rob Morocco, CFO, +1-949-855-7155,
robert.morocco@isotis.com; Hans Herklots, Director IR,
+1-949-855-7195 or +41-21-620-6011, hans.herklots@isotis.com