TORONTO, ONTARIO--(Marketwired - March 7, 2017) - Spectral Medical Inc. ("Spectral" or the
"Company") (TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic
septic shock using a medical device, today announced that it has received approval of the third module of its rolling PMA
submission from the United States Food and Drug Administration ("FDA) for Toraymyxin™. The third PMA module details the
device description and principles of operation and all manufacturing processes, including risk management and quality system
integration.
"We are very encouraged with the FDA's response and approval of the third module. This follows our announcement on February
23, 2017, that we plan to file our fourth and final module containing clinical data early in the second quarter of this year,"
stated Dr. Paul Walker, President and CEO of Spectral. "The acceptance of the third PMA module by the FDA is another step forward
on our regulatory pathway."
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 FDA cleared diagnostic for the risk of
developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, 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, whether the FDA will accept the Company's
submission of the final PMA module seeking potential approval of Toraymyxin™, the successful and timely completion of
clinical studies, the safety or efficacy of the Toraymyxin™, column, 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.