Irvine, California (ots/PRNewswire)
- Update on Recent Events
IsoTis, Inc. (NASDAQ: ISOT), the orthobiologics company, today
reported preliminary unaudited revenues for the fourth quarter and
full year ended December 31, 2006. Revenue was approximately US$10
million (unaudited) for the fourth quarter of 2006, representing a
16% increase over revenue of the fourth quarter of 2005. For the full
year 2006, revenue was approximately US$40 million (unaudited),
representing a 27% increase over revenue for the full year 2005.
IsoTis will report its complete fourth quarter and full year 2006
results on February 26, 2007.
Pieter Wolters, President and CEO of IsoTis said: "We are very
pleased with our continued progress in 2006 and the last quarter of
the year. I believe our 2006 revenues speak to the continued success
and acceptance of our Accell line of products, especially in the US
markets, and the healthy growth in our International markets and
increase in revenue from our Private Label agreements."
NASDAQ listing and Delisting from Euronext, TSX and SWX
IsoTis Inc. started trading on NASDAQ on January 26, 2007 after it
acquired approximately 75% of the outstanding IsoTis S.A.
(SWX/Euronext: ISON) (TSX: ISO) shares through an exchange offer
launched on December 15, 2006. Since that date, the Company has
acquired additional IsoTis S.A. shares through the exchange offer and
will hold greater than 90% of the outstanding IsoTis S.A. shares when
it closes the final portion of the exchange offer on February 14,
2007. IsoTis S.A. intends to have its shares delisted from Euronext
Amsterdam and the Toronto Stock Exchange as soon as possible.
Following a back-end merger to acquire the remaining IsoTis S.A.
shares, IsoTis, Inc. will cause the IsoTis S.A. shares to be delisted
from the SWX Swiss Exchange. Unless the context otherwise states,
references throughout this press release to "IsoTis" or the "company"
refer to the business of IsoTis S.A. and its subsidiaries for all
periods prior to the consummation of the exchange offer and to the
business of IsoTis, Inc. and that of its subsidiaries for all periods
subsequent to the consummation of the exchange offer.
On February 7, 2007 IsoTis received a letter from the U.S. Food
and Drug Administration (FDA) with additional comments and questions
regarding the Company's pending 510(k) application for its Accell
products. The letter raises a jurisdictional question as to whether
the Accell products should be regulated as a medical device.
Moreover, if regulated as a medical device, the letter questions
whether the Accell products are Class II or Class III devices.
IsoTis markets Accell Plus (previously referred to as Accell
Connexus) as a Class II medical device pursuant to a 510(k) received
from the FDA on July 7, 2005. IsoTis markets Accell Putty (previously
referred to as Accell DBM100) and Accell TBM, based upon the
Company's conclusion that they meet the requirements for regulation
solely as human cells, tissues and cellular and tissue-based
products, or 361 HCT/Ps, and do not require 510(k) clearance. On
October 19, 2006, IsoTis received a written determination from the
FDA that Accell Putty is not eligible for regulation solely as a 361
HCT/P. Although IsoTis continues to believe Accell Putty and Accell
TBM do satisfy the requirements to be regulated solely as a 361
HCT/P, because of the uncertainty surrounding the applicability of
the FDA's definition of a 361 HCT/P, the Company included the Accell
Putty and Accell TBM in its 510(k) submission for the entire Accell
family. That 510(k) submission remains pending with the FDA.
While IsoTis continues to believe that Accell Putty and Accell TBM
are 361 HCT/Ps, if the FDA were to definitively determine that they
are not, the Company believes they are class II medical devices and
that a 510(k) clearance will suffice to market the products. This is
consistent with the treatment of other competing products, the
Company's prior discussions with the FDA and the 510(k) clearance
previously received for Accell Plus.
Pieter Wolters stated: "Since the introduction of the first Accell
product in 2002, we have sold in excess of 50,000 units of Accell
products for use in a variety of orthopedic procedures such as spinal
fusion, joint replacements and trauma surgery. We have not received
any reported adverse events that have been attributed directly to our
materials, products or processes. We intend to continue to market the
Accell products and look forward to resolving the questions raised by
the FDA in a constructive and timely manner."
Today IsoTis is responding to both the October 2006 and February
2007 FDA letters and requesting to meet with the FDA to discuss the
Agency's questions. The Company believes that it can continue to
market Accell Putty and Accell TBM as 361 HCT/Ps until it receives
510(k) clearance, although there is no assurance that this will be
the case. There is also no assurance that the FDA will agree that
Accell Putty and Accell TBM are 361 HCT/Ps or, if the FDA were to
definitively determine that they are not 361 HCT/Ps, that they are
Class II medical devices. If the FDA were to determine that these
products are Class III medical devices or biologic products, the
Company will be subject to a more costly, lengthy and uncertain
approval process that could involve significant additional clinical
data or premarket approval. Moreover, there is no assurance that the
FDA will not take compliance measures against one or more of its
Accell products before the products receive market clearance, which
could include fines, injunctions and recalls of IsoTis' products.
Update on Public Offering
In light of the above described regulatory situation, the Company
has determined not to proceed with its proposed public offering of
common stock at this time and has withdrawn the Form S-1 registration
statement it filed with the Securities and Exchange Commission on
January 29, 2007.
February 26, 2007: Q4 and FY 2006 Results and Conference Call
IsoTis will report its complete fourth quarter and full year 2006
results on February 26, 2007. The Company has scheduled a conference
call to discuss these results on February 26, 2007at 5 pm EST. The
Company's results release will be distributed at approximately 4:30
p.m. EST that same day. US Dial In: 1 617 614 6206; UK Dial In 44 20
7365 8426; Continental Europe Dial In: 41 1 800 9569; no password
required. Digital playback is available from February 27 at 7:00 p.m.
for 24 hours. US Dial In: 1 617801 6888; European Dial In 44 20 7365
8427; playback ID: 22040500. To listen to the conference call live
via the internet, visit the Investors section of the IsoTis website
. Please go to the website 15 minutes prior to the
call to register, download and install the necessary audio software.
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, failure to obtain sufficient shareholder support for
the exchange offer, inability to list the IsoTis Inc, shares on
NASDAQ in a timely manner, if at all, 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 (a.o. EMEA,
CE), including the risk that the FDA determines that our Accell Putty
and Accell TBM products are not human tissue or class II medical
devices, that the Company is unable to obtain 510(k) clearance for
its Accell products, that the FDA requires the Company to obtain
premarket approval of its Accell products prior to continuing their
marketing, 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
ots Originaltext: IsoTis OrthoBiologics
Im Internet recherchierbar: http://www.presseportal.ch
For information contact:: Rob Morocco, CFO, +1-949-855-7155,
. Hans Herklots, Director IR,