Spectral to bring anti-sepsis therapy to the U.S. market



    TORONTO, Sept. 23 /CNW/ - Spectral Diagnostics Inc. (TSX: SDI) today
announced that it has agreed to key terms with Toray Industries Inc. of Japan
to obtain the exclusive development and commercial rights in the U.S. for
Toraymyxin(TM), a therapeutic for the treatment of sepsis that removes
endotoxin from the bloodstream. Under the terms of the agreement, the Company
will seek FDA approval for a combined product for the treatment of severe
sepsis that will include Toraymyxin(TM) and Spectral's Endotoxin Activity
Assay (EAA(TM)), the only FDA cleared diagnostic for the measurement of
endotoxin. The conclusion of final commercial agreements is subject only to
the completion of due diligence by Spectral and the determination of an
approved clinical development pathway with the U.S. FDA.
    "Toraymyxin(TM) is marketed in Japan and Europe and has been used to
treat more than 50,000 sepsis patients safely and effectively. Spectral's
EAA (TM) can identify patients that will benefit from Toraymyxin(TM) and
monitor the effects of the treatment," said Dr. Paul Walker, President and CEO
of Spectral. "This combination of the EAA(TM) diagnostic and the
Toraymyxin(TM) therapeutic has been utilized by clinicians in Europe since
November 2007 and has demonstrated the potential to lead to a significant
reduction in mortality, as documented in the findings presented at the 28th
International Symposium on Intensive Care and Emergency Medicine in March
2008. We believe that this combined treatment can fulfill a major unmet need
for the approximately 100,000 patients that develop severe sepsis or septic
shock in the U.S. each year."
    "The business alliance with Toray and the specific combination of our
approved diagnostic with their therapeutic device represent a significant
market opportunity for Spectral," said Anthony Businskas, Spectral's Executive
Vice-President and CFO. "Over the coming months, we expect to complete our due
diligence and discuss the clinical development pathway for this combined
product with the U.S. FDA. Finalization of the exclusive license and material
supply agreements with Toray is anticipated to occur in the first quarter of
2009."

    About Toray

    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
check www.toray.co.jp.

    About Spectral Diagnostics

    Spectral is a leader in the battle against sepsis. Spectral's lead
product is its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay
for the measurement of endotoxin. With the growing awareness for the role of
endotoxemia in sepsis and the increasing number of therapies being developed
for this indication, Spectral is well-positioned to drive the adoption of the
EAA(TM), which can be used to identify patients, enable therapeutics and
monitor treatment. Spectral is listed on TSX under the symbol SDI.

    Forward-looking statement

    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:

For further information: Dr. Paul Walker, President & CEO, (416)
626-3233 ex. 2100; James Smith, Investor Relations, (416) 815-0700 ext. 229,
jsmith@equicomgroup.com

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