TORONTO, Feb. 21, 2019 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”)
(TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic septic shock
guided by a companion diagnostic, today announces that, following the execution of the previously announced distribution agreement
for its proprietary continuous renal replacement therapy (CRRT) machine with a private U.S. company, Spectral is now ready to ship
out the first order of machines and related disposable for a cumulative revenue of $120,000 CAD. A second order in excess of
$450,000 CAD has been processed and will be ready for shipment in Q2.
“The Spectral CRRT machine was developed to be user friendly and flexible in performing continuous renal
replacement therapy in a variety of modalities. We are working closely with our early adopters to ensure its successful launch,”
said Dr. Gualtiero Guadagni, Vice President of Sales & Marketing at Spectral.
About Spectral’s CRRT Machine
The Spectral CRRT machine (previously known as the “SAM” PUMP) is an innovative instrument based on a patented cassette technology
that can be used for CRRT and therapeutic plasma exchange (TPE) modalities. This CRRT Machine is user friendly, built on a small
footprint, and allows for use of any dialyzer and/or dialysis membrane available on the market. The Company has exclusive license
rights for the CRRT machine in North America for all hospital applications and has worldwide exclusivity for hemoperfusion
application.
About Spectral
Spectral is a Phase III 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 Endotoxin Activity Assay (EAA™), the only US FDA cleared diagnostic for the risk of developing
sepsis.
PMX has been approved for therapeutic use in Japan, Europe and Asia and has been used safely and effectively on
more than 150,000 patients 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. Approximately 350,000
patients are diagnosed with severe sepsis and septic shock in North America each year. 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
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 and clinical trials, 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, general economic, market and business conditions, as well
as other risks and uncertainties which are more fully described in Spectral’s Annual Information Form dated March 28, 2018, and in
other filings of Spectral with securities and regulatory authorities which are available at www.sedar.com. Spectral does not
undertake any obligation to update forward-looking statements should these assumptions change. Nothing in this document should be
construed as either an offer to sell or a solicitation to buy or sell Spectral securities.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this
statement.
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