Spectral Medical to Present at the 3rd Annual H.C. Wainwright BioConnect Investor Conference
Investors interested in scheduling a meeting with the Company's management team should contact their H.C. Wainwright representative or email
meetings@hcwco.com
.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ ('PMX'). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company's FDA cleared Endotoxin Activity Assay (EAA™), the clinically available test for endotoxin in blood.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively over 360,000 times to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis
https://www.youtube.com/watch?v=6RANrHHi9L8
.
The trial methods are detailed in '
Bayesian methods: a potential path forward for sepsis trials
'.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit
www.spectraldx.com.
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 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.
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