IsoTis Extends Private Label With AlloSource for First Generation DBM Products $2.5 Million Payment on Closing
22 Mai 2007 - 3:01PM
PR Newswire (US)
IRVINE, California, May 22 /PRNewswire-FirstCall/ -- IsoTis, Inc.
(NASDAQ:ISOT), the orthobiologics company, today announced that it
has expanded its existing private label agreement with AlloSource.
AlloSource is IsoTis' primary supply partner and one of the
nation's largest non-profit providers of bone and soft tissue
allografts for use in surgical procedures. Under the agreement
AlloSource receives an exclusive license to use the intellectual
property necessary to manufacture products similar to IsoTis' first
generation DBM products in North America, and a non-exclusive
license to market them to and through AlloSource's own distribution
or private label partners. IsoTis retains all intellectual property
and rights on global manufacturing and distribution, including the
ability to enter into additional private label agreements. IsoTis
will remain the sole manufacturer for its own first generation
products, DynaGraft(R) II & OrthoBlast(R) II, for the first
generation DBM products it currently manufactures under private
label agreements with parties other than AlloSource, as well as for
private label products under potential new contracts IsoTis may
enter into. IsoTis' Accell family of products (Accell 100, Accell
Connexus, Accell TBM and any new Accell products IsoTis may
develop), are not related to nor affected by the expanded agreement
with AlloSource. IsoTis remains the sole and exclusive manufacturer
and market supplier of Accell products. The agreement took effect
on May 18, 2007. Upon closing, IsoTis received an upfront payment
of $2.5 million. On the first Anniversary of the expanded
agreement, an additional earnout payment may be due by AlloSource,
based on and depending on first year sales by AlloSource. Pieter
Wolters, President and CEO of IsoTis said, "We are pleased to
strengthen our relationship with AlloSource, our primary supplier
of tissue and one of our trusted private label partners. The
agreement fits our increased focus on the further development of
our proprietary Accell technology and the commercial rollout of the
Accell products, which represented approximately 70% of our US
sales in the first quarter of 2007. The $2.5 million upfront
payment gives us additional room to consider the various financing
alternatives for investments in our future growth and current
operations." 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, the Company's need to raise additional capital
to continue operations, a competitive sales and marketing
environment, the effects of the Allosource license agreement on the
Company's ongoing operations, 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
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, 2006 of IsoTis S.A. (the predecessor
to IsoTis, Inc.), and its 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 March 31, 2007
and other reports filed with the SEC from time to time by IsoTis,
Inc. DATASOURCE: IsoTis Inc CONTACT: For information contact: Rob
Morocco, CFO, +1-949-855-7155, ; Hans Herklots, Director IR,
+1-949-855-7195 or +41-21-620-6011,
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