- Pivotal trial results to be announced immediately after end of Q3 16 - Final PMA Module scheduled for submission to FDA in Q4
16
TORONTO, ONTARIO--(Marketwired - Aug. 18, 2016) - Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF) (the
"Company"), a Phase III company developing the first treatment for patients with endotoxemic septic shock guided by a
companion diagnostic, today announced that it expects to release primary end point results for its pivotal EUPHRATES trial
immediately after the end of the third quarter ended September 30, 2016. The trial was completed in June of this year.
In addition, the Company announced that the United States Food and Drug Administration ("FDA") has completed its initial
review of the third module of the Company's PMA submission and the 510k submission for the Company's standalone pump. The Company
is in the process of responding to the FDA's initial queries and is on track to file the final PMA module with clinical data in
the fourth quarter of this year.
"We are eagerly awaiting the results of our clinical trial, which was designed to show a significant reduction in the
mortality of patients with endotoxemic septic shock. Pending satisfactory results, we would expect to proceed with completion of
our regulatory filings in the fourth quarter as we seek approval for our targeted treatment which is guided by a diagnostic",
said Dr. Paul Walker, President and CEO of Spectral. "If approved, this treatment could be available to patients by as early as
the first half of 2017", added Dr. Walker.
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 directed 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. Approximately 350,000 patients are diagnosed with severe sepsis and septic shock in North America each
year, representing a greater than $3 billion market opportunity for Spectral. Currently there is no specific treatment available
for this condition. Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTCQX under the symbol
EDTXF. 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.