TORONTO, March 9 /CNW/ - Spectral Diagnostics Inc. (TSX:SDI) today
announced that it has signed a license agreement with Toray Industries, Inc.
of Japan granting Spectral the exclusive development and commercial rights in
the U.S. for Toraymyxin(TM), a therapeutic device for the treatment of sepsis
that removes endotoxin from the bloodstream. Under the terms of the agreement,
Spectral will seek FDA approval for Toraymyxin(TM) and intends to
commercialize the product together with its Endotoxin Activity Assay
(EAA(TM)), the only FDA cleared diagnostic for the measurement of endotoxin.
"The finalization of this agreement, on schedule, is an important
milestone for Spectral and demonstrates the significant progress we have made
on our path to delivering an effective treatment for severe sepsis in the
United States. Toraymyxin(TM) has been used on more than 70,000 patients to
date, primarily in Europe and Japan, for the treatment of severe sepsis caused
by endotoxemia," said Dr. Paul Walker, President and CEO of Spectral.
"Furthermore, together with our proprietary EAA(TM), the combination has
demonstrated a significant reduction in the mortality of patients with severe
sepsis compared to standard of care in European clinical trials. This
innovative product has the potential to fulfill a severely unmet need for the
approximately 100,000 patients that develop severe sepsis or septic shock in
the U.S. each year."
Spectral plans to conduct a pre-Investigational Device Exemption
(pre-IDE) meeting with the U.S. FDA this quarter as a first step towards
gaining clearance for its clinical strategy, with the objective of initiating
clinical trials in the latter half of 2009.
Toray Industries, Inc. is a leading diversified chemicals corporate group
that has been technology-focused since its foundation in 1926. The company's
operations are underpinned by technological expertise in organic synthetic
chemistry, polymer chemistry, and biochemistry. These innovative technologies
have yielded "advanced materials" that Toray is now exploiting to provide
customers with comprehensive solutions through Fibers and Textiles, Plastics
and Chemicals, IT-related Products, Carbon Fiber Composite Materials,
Environment and Engineering, Life Science and Other Business divisions. In
FY2008, Toray had consolidated sales of 1,650 billion yen (approx $15 billion
US), and over 33,000 employees worldwide. For further information, please
About Spectral Diagnostics
Spectral is a developer of innovative technologies for comprehensive
disease management. Spectral's lead product is its EAA(TM) Endotoxin Activity
Assay, the only FDA approved diagnostic for the measurement of endotoxin.
Spectral technologies provide accurate and timely information to clinicians
enabling the early initiation of appropriate and targeted therapy. Spectral is
listed on TSX under the symbol SDI.
Information in this news release that is not current or historical
factual information may constitute forward-looking information within the
meaning of securities laws. Implicit in this information, particularly in
respect of the future outlook of Spectral and anticipated events or results,
are assumptions based on beliefs of Spectral's senior management as well as
information currently available to it. While these assumptions were considered
reasonable by Spectral at the time of preparation, they may prove to be
incorrect. Readers are cautioned that actual results are subject to a number
of risks and uncertainties, including the availability of funds and resources
to pursue R&D projects, the successful and timely completion of clinical
studies, the ability of Spectral to take advantage of business opportunities
in the biomedical industry, the granting of necessary approvals by regulatory
authorities as well as general economic, market and business conditions, and
could differ materially from what is currently expected.The TSX has not reviewed and does not accept responsibility for the
adequacy or accuracy of this statement.%SEDAR: 00002006E
For further information: Dr. Paul Walker, President & CEO, (416)
626-3233 ex. 2100; Casey Gurfinkel, Investor Relations, (416) 815-0700 ext.