FDA Accepts Spectral's PMA for Toraymyxin(TM) for Review
TORONTO, ONTARIO--(Marketwired - July 24, 2017) - Spectral Medical Inc. (TSX:EDT), a Phase
III company developing the first treatment for patients with septic shock, today announced that the United States Food and
Drug Administration ( "FDA") has accepted its rolling PMA application for Toraymyxin™ ("PMX") for review.
The acceptance of the filing means that the FDA has made a threshold determination that the application is sufficiently
complete to permit a substantive review. The Company will continue to work closely with the FDA to facilitate a timely
process.
"The acceptance of this PMA filing for review by the FDA represents another significant step forward in our regulatory pathway
towards potential approval of our personalized treatment for patients with endotoxemic septic shock. The incidence of sepsis
continues to rise in North America with no specific treatment yet available," said Dr. Paul Walker, President and CEO of
Spectral.
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, 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.